Healthcare Diagnostics – Procedure

Document Name: DQSP-00080

Document Title: Product Labeling Procedure
Effective Date: 15-Apr-2021 Version: 8.0

1.0 Purpose
The purpose of this procedure is to define global regulatory and commercial requirements and
harmonized guidelines for labeling of products within Siemens Healthcare Diagnostics, including
Laboratory Solutions (LS) and Point of Care (POC). These requirements include those for In
Vitro Diagnostics (IVD), Research Use Only (RUO), Investigational Use Only (IUO), General
Purpose Reagent (GPR), and Analyte-Specific Reagent (ASR) regulatory classifications.

New requirements in this version of the procedure shall be applied to new product labeling
projects starting 90 days after this procedure is effective. Requirements in this procedure may
be incorporated into labeling revision of commercial products, but the impact of content changes
to product registration or importation must be evaluated by Quality and Regulatory functions.

2.0 Scope
This procedure applies to product labeling for products that are manufactured or distributed as
Siemens or Siemens Healthineers-branded. “Product Labeling” is defined as information
provided to end-users, either directly on a product or supplied with a product, describing
features, performance claims and specifications, storage and handling requirements, correct
product use, and product safety. Examples of product labeling include on-product marking,
instructions for use, operator guides, online help, user interface content, quick reference guides,
text and graphics for primary component, outer container/unit of sale carton, and shipping
container packaging.

Requirements for other forms of customer communication, including Service, Marketing, and
Advertising materials, are not within the scope of this procedure.

This procedure includes regulatory and corporate requirements, including the FDA Labeling
Regulations, EC-In Vitro Diagnostic Directive (IVDD), EC In Vitro Diagnostic Regulation (IVDR),
EN and ISO standards, global country regulatory requirements, and Siemens EHS, Legal,
Corporate Communications and Design requirements.

NOTE: The new requirements for IVDR need to be fulfilled after the application date on May 26,
2022, unless the prolonged transitional provision of the IVDR (latest May 26, 2024) is used for
non-changed products. However, the registration requirements need to be fulfilled starting May
26, 2022.

This document does not define country-specific regulatory or product safety requirements for
Russia, Japan, China, Taiwan, Korea, Vietnam, or Thailand. Developers shall obtain labeling
requirements directly from Quality/Regulatory functions in these countries. Many countries
require additional labeling on products for commercial importation or customs purposes with
local contact information; these requirements are not covered in this document.

This procedure does not include guidance on local language requirements for system or assay
labeling or use of electronic delivery of IFUs.

This procedure reflects use of both Siemens and Siemens Healthineers branding guidance; the
organization’s PLM function is responsible for decisions regarding a specific product’s branding.

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Healthcare Diagnostics – Procedure

Document Name: DQSP-00080

Document Title: Product Labeling Procedure
Effective Date: 15-Apr-2021 Version: 8.0

3.0 Roles, Responsibilities and Functional Group(s)

Roles Responsibilities Functional Group(s) /

(Who is responsible (Major tasks to be carried out) Teams that typically
to carry out the tasks) perform this role
Regulatory Affairs  Monitor, define, and communicate new and revised  Regulatory Affairs
global regulations and regional directives that may
impact product labeling content.
 Provide assessment of regional impact when new
content requirements are planned for product labeling,
to ensure proposed content does not conflict with local
labeling requirements, affects commercial product
registration or importation.

Corporate  Provide and maintain corporate guidelines for  Corporate

Communications application and use of the Siemens Healthineers Communications
graphic identity as applied to products, packaging, and
documentation.
Legal  Advise on legal address variations and providing country  Legal
of origin guidance.
Intellectual Property  Provide and maintain corporate guidelines for  Intellectual Property
application and use of Siemens and OEM trademarks,
patent marking, copyrights, and legal statements.
 Maintain listing of all active product trademarks.
 Provide product patent information relevant for labeling.

Environment, Health  Provide product safety classifications and guidelines for  Environment, Health and
and Safety (EHS) the specification of Hazard, Risk and Safety information, Safety
including placement and delivery of that information to
product users.

Technical  Monitor, define, and communicate new and revised  Technical Regulations
Regulations and Technical Regulations and Standards (TR&S) that are and Standards
Standards relevant to product labeling content requirements. Management (TRSM-
Management Support the business through interpretation and DX)
(TRSM-DX) analysis of TR&S.

Product Labeling  Understand applicable regulatory, commercial, and  Product Labeling

corporate requirements that affect product labeling
content and delivery.
 Develop labeling content and design solutions to reflect
this procedure. If needed, propose design, format, or
delivery options for functional review.
 Produce product labeling artwork and documents,
following appropriate review/approval procedures, and
transfer final/approved versions to appropriate control
and delivery systems.
 Maintain alignment of these product labeling standards
to applicable internal and external standards and
regulations.

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Healthcare Diagnostics – Procedure

Document Name: DQSP-00080

Document Title: Product Labeling Procedure
Effective Date: 15-Apr-2021 Version: 8.0

4.0 Process Description

This procedure is to be used by labeling project leaders, content developers, and designers as
the basis for planning and development of new labeling or substantial modification of existing
product labeling. Developers are cautioned to confirm the extent of labeling changes to
commercial products with Regulatory Affairs (RA) representatives, as labeling changes to these
products may result in product re-registration or notification activities in some regions.

Requirements in this procedure shall be implemented as specified, in order to produce materials

that are in compliance with all applicable country and corporate regulatory requirements.

Requirements listed are preceded by the word “shall” or “will”; suggested practices are generally
preceded with the word “may”. Italicized examples in the document are guidance for the
structure of required words or phrases.

Issues that limit the complete implementation of specified labeling requirements shall be
reviewed with the appropriate Quality and Product Labeling functional management before
content deletions or modifications may be implemented.

In some cases, physical space on labeling limits the application of complete information. In such
cases, alternative specifications and formats are described in the requirements. If an alternative
specification cannot be implemented, contact appropriate Quality and Product Labeling
functional management to identify implementation options.

4.1 Reagent / Assay Labeling Requirements

Product labeling for reagents includes component labeling (labeling on the device or
reagent container), outer container/unit of sale carton labeling and instruction for use or
product insert that is provided to customers.

4.1.1 Component Labeling

The basic content requirements for reagent component labeling are included in the table
below. If a reagent or consumable is shipped to its end-user without outer packaging, the
component label shall also contain information required of the outer container/unit of
sale carton labeling (4.1.2).

Each component shall be identified by name, letter, number, symbol, color, or graphics
in the same manner on all labels and in the instructions for use.

Required Element General Requirement Minimum requirement References

for space-constrained (within this
application procedure)
Manufacturer Full “Siemens” or “Siemens Legal Manufacturer’s 4.3.2
Healthineers” logo, plus Legal address in text; full 4.3.6
Manufacturer’s address. branding and legal
address must be on outer
Packaging and in the IFU.

Product Name Unique proprietary name in Short-form or Mnemonic 4.3.4

English. only (such as “TSH”)

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Healthcare Diagnostics – Procedure

Document Name: DQSP-00080

Document Title: Product Labeling Procedure
Effective Date: 15-Apr-2021 Version: 8.0

Required Element General Requirement Minimum requirement References

for space-constrained (within this
application procedure)
System If component name is not unique Same 4.3.4
within Siemens, include system
or application name.

Product mnemonic Assay/reagent ‘short’ name or Same See Product Name

EDMA-formatted self- defined
symbol.

Batch/Lot Code “LOT” symbol with code. Same 4.3.8

DQSP-00080-G1
Symbols Glossary

Use By/Expiration “EXP” (Use By) symbol plus Same 4.3.8

Date formatted date YYYY-MM-DD. DQSP-00080-G1
Symbols Glossary

Number of Tests, Number of tests contained Same 4.3.9

Volume, Quantity adjacent to “sufficient for” DQSP-00080-G1
symbol; mass or volume with Symbols Glossary
units or measure.

Intended Use “IVD” symbol or other intended Same 4.3.13

use symbols or statements (e.g. DQSP-00080-G1
IUO symbol).
Symbols Glossary

Intended Purpose IVD symbol plus product name Same 4.3.13

DQSP-00080-G1
Symbols Glossary

Storage and “Storage Temperature” symbol Same 4.3.10

Handling and storage temperature range. DQSP-00080-G1
Symbols Glossary

Warnings and Any storage and handling risks, Space-constrained sizing 4.3.10
Precautions including GHS Chemical Safety for symbols (refer to 4.5
Information Hazard Symbol and attachment DQSP-00080-
DQSP-00080-G1
Signal Word. G1, Symbols Glossary);
Symbols Glossary
GHS Hazard Symbol

Compliance Marking CE mark, for IVD products sold CE mark provided on 4.3.12
(if component is a in the EU; with Notified Body outer packaging and IFU
registered medical number for IVDD Annex II is acceptable
device) products and IVDR class B, C
and D products.

Microbiological State “Sterile” symbol if applicable . Same DQSP-00080-G1

Symbols Glossary

Reuse “Do Not Reuse” symbol if device Same DQSP-00080-G1

cannot be used or replenished Symbols Glossary
after single use.

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Healthcare Diagnostics – Procedure

Document Name: DQSP-00080

Document Title: Product Labeling Procedure
Effective Date: 15-Apr-2021 Version: 8.0

Required Element General Requirement Minimum requirement References

for space-constrained (within this
application procedure)
Biological Hazard “Biohazard” Symbol if product Same 4.3.11
contains a known biological DQSP-00080-G1
hazard. Symbols Glossary

Device Identification Manufacturer’s product code Same N/A

(component part number) or
other identifier.

Patent/IP US Patent Number or Patent Number or URL on 4.3.5

appropriate URL where patent outer carton or IFU is
number is available, if applicable acceptable
(recommended directly on
container or its label).

Specimen Type Type of specimen(s) required to Outer packaging and IFU N/A
(devices for self- perform the test (e.g. blood, acceptable.
testing only) urine, or saliva).

Additional Materials The need for additional materials Outer packaging and IFU N/A
(devices for self- for the test to function properly. acceptable.
testing only)

Contact Details Contact details for further advice Outer packaging and IFU N/A
(devices for self- and assistance. acceptable.
testing only)

Self-testing or Near “Self-Test” or “Near Patient Test” Outer packaging and IFU 4.3.13
Patient Testing symbol if the device is intended acceptable. DQSP-00080-G1
Indication (product for self-testing or near-patient Symbols Glossary
sold in EU countries testing.
only)

Exclusion for Rapid “Non Self-Test” or “Non Near Outer packaging and IFU 4.3.13
Assays (product sold Patient Test” symbol where rapid acceptable. DQSP-00080-G1
in EU countries only) assays are not intended for self- Symbols Glossary
testing or near-patient testing.

4.1.2 Outer Container / Unit of Sale Carton Labeling

The content requirements for outer container / unit of sale packaging are
included in the summary table below.

Required Element General Requirement Minimum requirement References

for space-constrained (within this procedure)
application

Manufacturer “Siemens” or “Siemens Same 4.3.2

Healthineers” logo and full Legal 4.3.6
Manufacturer’s address.

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Healthcare Diagnostics – Procedure

Document Name: DQSP-00080

Document Title: Product Labeling Procedure
Effective Date: 15-Apr-2021 Version: 8.0

Required Element General Requirement Minimum requirement References

for space-constrained (within this procedure)
application

EC Authorized Full address of EC Authorized Same 4.3.6

Representative Representative near the legal
manufacturing address, if the
product is CE marked and the
Legal Manufacturer is located
outside of the European Union.

Product Name Proprietary name in English. Same 4.3.4

Country of Origin Origin: (Country code) Same 4.3.7

Product mnemonic Assay/reagent ‘short’ name or Same 4.4.1

EDMA-formatted self-defined
component symbol.

System If product name is not unique Same 4.3.4

within Siemens, include system or
application name.

Unique Device UDI content (for registered Same DQSP-00080-A1

Identification (UDI) devices), manufacturer’s product Product Identification
and Product Code code with “REF” symbol, and “UDI” Labeling
symbol if there is more than one DQSP-00080-G1
barcode on the saleable product. Symbols Glossary

Batch/Lot Code “LOT” symbol with code. Same 4.3.8

DQSP-00080-G1
Symbols Glossary

Use By/Expiration “EXP” (Use By) symbol plus Same 4.3.8

Date formatted date (YYYY-MM- DD). DQSP-00080-G1
Symbols Glossary

Contents Description of items contained Same 4.3.9

(e.g. number of tests). 4.3.14
4.3.16
For Kits with multiple components,
description of items contained.

For US and Canada, Active

ingredients and other ingredients
as applicable in English.

Preparation Reconstitution or other preparation May be included in IFU N/A

information if reagent is not ready only
to use.

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Healthcare Diagnostics – Procedure

Document Name: DQSP-00080

Document Title: Product Labeling Procedure
Effective Date: 15-Apr-2021 Version: 8.0

Required Element General Requirement Minimum requirement References

for space-constrained (within this procedure)
application

Intended Use “IVD” symbol, or other intended Same 4.3.13

use graphic symbol. 4.3.14
For US/CA, Intended Use DQSP-00080-G1
statement in English. RUO Symbols Glossary
products, Intended Use statement
is required in local language.

Intended Purpose “IVD” symbol plus product name. Same 4.3.13

DQSP-00080-G1
Symbols Glossary

Storage and Handling “Storage Temperature” symbol + Same 4.3.10

Storage temperature range, DQSP-00080-G1
“Fragile”, “Keep away from” and Symbols Glossary
other handling symbols as
appropriate to insure correct
handling.

Warnings and Any storage and handling risks, Same 4.3.10

Precautions including GHS Chemical Safety 4.5
Information Hazard Symbol, Signal
DQSP-00080-G1
Word, H+P Codes.
Symbols Glossary

Compliance Marking CE mark, for IVD products sold in Same 4.3.12

the EU; with Notified Body number
for IVDD Annex II products and
IVDR class B, C and D products.

Microbiological State “Sterile” symbol if applicable. Same DQSP-00080-G1

Symbols Glossary

Instructions for Use “Consult Instructions for Use” Same 4.4.2

symbol unless instructions for use DQSP-00080-G1
are on the product or the carton. Symbols Glossary
Note: URL must include
If product IFU is delivered /eifu
electronically, use of “eIFU”
symbol, with access URL and IFU
version code.

Reuse “Do Not Reuse” symbol if device Same DQSP-00080-G1

cannot be used or replenished Symbols Glossary
after single use.

Biological Hazard “Biohazard” Symbol and warning “Biohazard” symbol alone, 4.3.11
phrase if product contains a known statement shall be in IFU. DQSP-00080-G1
biological hazard. Symbols Glossary

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Document Name: DQSP-00080

Document Title: Product Labeling Procedure
Effective Date: 15-Apr-2021 Version: 8.0

Required Element General Requirement Minimum requirement References

for space-constrained (within this procedure)
application

Country-Specific TK number, “T.K. 00-00” if Same 4.3.15

applicable for products sold in
Canada containing controlled
substances.

Patent/IP US Patent Number or appropriate Patent number or URL in 4.3.5

URL identifying where patent IFU is acceptable.
number is available, if applicable (if
marking on component is not
possible).

Label Part Number Unique identifier to control version Same N/A

and use of labeling artwork on
packaging.

Specimen Type Type of specimen(s) required to If outer packaging is N/A

(devices for self-testing perform the test (e.g. blood, urine space constrained, IFU
only) or saliva). only is acceptable.

Additional Materials The need for additional materials If outer packaging is N/A
(devices for self-testing for the test to function properly. space constrained, IFU
only) only is acceptable.

Contact Details Contact details for further advice If outer packaging is N/A
(devices for self-testing and assistance. space constrained, IFU
only) only is acceptable.

Self-testing or Near “Self-test” or “Near Patient Test” Same 4.3.13

Patient Testing symbol if the device is intended for DQSP-00080-G1
Indication (products self-testing or near-patient testing. Symbols Glossary
sold in EU countries
only)

Exclusion for Rapid “Non Self-Test” or “Non Near- Same 4.3.13

Assays (products sold Patient Test” symbol where rapid DQSP-00080-G1
in EU countries only) assays are not intended for self- Symbols Glossary
testing or near-patient testing.

4.1.3 Labeling Content for Assay/Reagent Instructions for Use (IFU)

Instructions for Use (IFUs) are required for all IVD reagent products, except certain
ancillary reagents and supplies under these conditions:
a. the reagents are used for a specific analytical process step (such as wash,
sample dilution or pretreatment).
b. provide no direct test result.
c. Product description, material handling procedures, intended use and product
safety risks are adequately included in the product labeling, primary reagent IFU
or instrument manual.

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Document Name: DQSP-00080

Document Title: Product Labeling Procedure
Effective Date: 15-Apr-2021 Version: 8.0

d. Risk and Safety information (GHS) required for safe handling is provided on
product packaging or other means with the product.

All assay/reagent product IFUs shall be developed using a standardized sequence of

information topics; although the content within each heading may vary due to product
classification, use and performance. Determining whether IFU content constitutes
performance or usability claims is the responsibility of the Regulatory Affairs function.

Where applicable, information regarding batch to batch variation with relevant figures
and units of measure shall be provided to the customer. This information may be
included in the IFU or in another document that accompanies the IFU.

Information shall be provided defining traceability of values assigned to calibrators and

control materials, including identification of applied reference materials and/or
measurement procedures. This information may be included in the IFU or in another
document that is provided to customers.

Requirements for Reagent Instructions for Use

4.1.3.1 Company Logo and Company Name
“Siemens” or “Siemens Healthineers” logo, and platform logo, if
applicable.

4.1.3.2 Readability
For Self-Test and CLIA-waived products, the IFU shall be written to
audiences with limited diagnostics training, and for Self-Test products,
enabling a lay user (for example, in the US, at a seventh grade reading
level) to correctly and safely perform the IVD test procedure and
understand the IVD test results.

4.1.3.3 Revisions
Changes to content from old to new versions of IFUs shall use change-
bars or other highlighting features that visually identifies new or revised
text. Alternatively, a revision information section can be added identifying
new or updated content. Change bars, highlighting or revision information
section shall be included in all language IFUs.

4.1.3.4 Compliance Marking

For CE marked IVD products sold in the European Union, the CE mark is
required. For IVDD Annex II and IVDR class B, C, and D devices, the CE
marking shall be followed by the identification number of the notified body
responsible for the conformity assessment procedures.

4.1.3.5 Regulatory Classification

a. IFUs for RUO product shall include the for research use only
statement.

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Document Name: DQSP-00080

Document Title: Product Labeling Procedure
Effective Date: 15-Apr-2021 Version: 8.0

b. IFUs for IUO product shall include the for investigational use only
statement.

c. IFUs for PEO product shall include the for performance evaluation
only statement.

d. IFUs for devices for performance studies shall include the device
for performance study only statement.

4.1.3.6 Proprietary Name of product

a. Include any mnemonic or symbol for product used on labeling.
b. If applicable, include name of system that reagent is used with.

4.1.3.7 Intended Use and Intended Purpose

Note: For US-PMA assays, any warnings that are part of the intended use
must appear before the intended use section
Note: All elements of the intended purpose as required by the EC IVD
Regulation must be included in the IFU, however, not all elements need
to be under the Intended Use section of the IFU. For Self-Test products,
the device’s intended purpose shall provide sufficient information to
enable the user to understand the medical context and to allow the
intended user to make a correct interpretation of the results. A statement
that the product is intended for self-testing shall be provided. For IVDR
CE marked near-patient test products, a statement that the product is
intended for near-patient testing shall be required.
For IVDR CE marked rapid assays, rapid tests which are not intended for
self-testing or near-patient testing shall indicate this.

4.1.3.8 Summary and Explanation

4.1.3.9 Principles of the Procedure

For Self-Test products: The principle of the examination method shall be
briefly described, in terminology suitable for a lay person, to provide the
user with the necessary basic information.
4.1.3.10 Reagent Description
a. Established name, and quantity, proportion or concentration of each
reactive ingredient; for biological material, the source and a measure
of its activity.
b. Warnings and Precautions
• Warnings and warning statements
• For in vitro diagnostic use statement (unless RUO or IUO
product)
• Statement limiting the use of a prescription IVD (if applicable)
• Cautions and caution statements
• Hazardous disposal statement
• Intended user

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Document Title: Product Labeling Procedure
Effective Date: 15-Apr-2021 Version: 8.0

• Residual risks required to be communicated to the user shall be

included as limitations, contraindications, precautions, or
warnings.
• Where appropriate, warnings, precautions, and/or measures to
be taken shall be added to the instructions for use in the event of
malfunction of the device or its degradation, as suggested by
changes in the appearance that may affect performance.
• For IVDR class C and D devices sold in the EU, a statement shall
be added to the instructions for use identifying where the safety
and performance summaries are available.
• For Self-Test products used for the monitoring of a previously
diagnosed existing disease or condition, the information shall
specify that the patient should only adapt the treatment if he/she
has received the appropriate training to do so.
c. Preparing Reagents (Note: for manual methods see 4.1.3.12
Procedure)
d. Storage and Stability, including Onboard Stability if applicable,

4.1.3.11 Specimen Collection and Handling

a. Collecting the Specimen
b. Storing the Specimen
c. Transporting the Specimen (if applicable to analytical method)
d. Preparing the Samples

4.1.3.12 Procedure
a. Materials Provided
b. Materials Required but Not Provided
c. Optional Materials (if applicable)
d. Procedure
e. Preparing the Reagents (for manual methods)
f. Preparing the System
g. Performing Calibration
h. Performing Quality Control
For Self-Test products, details of the test procedure shall be given,
including any reagent preparation, specimen collection and/or
preparation and information on how to run the test and interpret the
results.

4.1.3.13 Results
a. Calculation of Results

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Document Title: Product Labeling Procedure
Effective Date: 15-Apr-2021 Version: 8.0

b. Interpretation of Results

For Self-Test products, the following principles must be complied with

as well.
a. Results shall be expressed and presented in a way that is
readily understood by the intended user.
b. Significance of the test results obtained shall be explained,
including actions to be taken based on the test results, taking
into account the possibility of incorrect results and any factors
that can affect the test results.
c. The information shall include a statement directing the user not
to make any medical decision without first consulting his or her
healthcare provider, information on disease effects and
prevalence, and where available, information specific to the
Member State(s) where the device in marketed on where a user
can obtain further advice such as national helplines and
websites.

4.1.3.14 Limitations

4.1.3.15 Expected Values

a. Reference Interval
b. Therapeutic Interval (if applicable)

4.1.3.16 Performance Characteristics (include as appropriate)

The instructions for use shall contain clinical performance characteristics,

such as threshold value, diagnostic sensitivity and diagnostic specificity,
positive and negative predictive value.
a. Measuring Interval
b. Extended Measuring Interval (if applicable)
c. Detection Capability
d. Clinical Sensitivity and Specificity (if applicable, may replace
Detection Capability)
e. Precision
f. Assay Comparison
g. Specimen Equivalency
h. Interferences
i. Specificity
j. Linearity
k. On-board Dilution (if applicable)
l. High-Dose Hook Effect
m. Standardization

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4.1.3.17 Technical Assistance (If required within Commercial business unit)

For products sold in the EU, a serious incident reporting statement shall
be added instructing the user to report serious incidents to the
manufacturer and the competent authority of the EU Member State in
which the user and/or patient is established.

4.1.3.18 Definition of Symbols

All symbols used to convey product labeling description, use or handling

information on components or unit-of-sale packaging

4.1.3.19 Trademarks, Patents and Copyright Notices

4.1.3.20 Name and address of Legal Manufacturer

Full address of Legal Manufacturer, plus Siemens Healthineers
Headquarters address, phone number and internet URL:

Siemens Healthineers Headquarters

Siemens Healthcare GmbH
Henkestr. 127
91052 Erlangen Germany
Phone: +49 9131 84-0
siemens-healthineers.com

For products sold in the European Union, the name and address of the
manufacturer's EC Authorized Representative is required if the product
is CE marked and the legal manufacturer is not located within the EU.
Note: If the name and address of the EC Authorized Representative is
present on the outer packaging, they are not required to be in the
instructions for use.

4.1.3.21 Unique Document identifier to control use with specific product

configurations: SMN, revision code and date of issuance of revision
(YYYY-MM).

4.1.3.22 Where relevant, requirements for special facilities, special training

or qualifications of the intended user.

4.2 System / Software Labeling Requirements

This procedure provides the basic requirements for product labeling of systems and
software products, system supplies and consumables. Requirements are derived from
IVD and Medical Device directives, electrical and mechanical safety regulations.

Product labeling for systems and software includes on-product marking, packaging /unit
of sale carton and the Instructions for Use and other mandatory information that is
provided to customers.

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Document Title: Product Labeling Procedure
Effective Date: 15-Apr-2021 Version: 8.0

4.2.1 System Identification/Rating Label

The basic content requirements for the system identification/rating label are
included in the summary table below. All product identification content shall be
marked on a permanent part of the system, printed using permanent inks, label
stocks and adhesive systems from approved and compliant marking systems.
Some elements may be presented on the UDI labeling adjacent to the rating
label.

Required Element General Requirement Minimum requirement References

for space-constrained (within this
application procedure)

Manufacturer “Siemens” or “Siemens Same 4.3.2

Healthineers” logo and full Legal
Manufacturers address.

EC Authorized Full address of EC Authorized Same

Representative Representative, if the product is DQSP-00080-
CE marked and the Legal G2 Legal
Manufacturer is located outside Manufacturer
of the European Union. Address

Country of Origin Origin: (Country code) Same 4.3.7

Product Name Unique proprietary name in Same 4.3.1

English.

System If product is used in combination Same 4.3.4

with a system, identify the
system.

Unique Device UDI content and customer- Same DQSP-00080-

Identification (UDI) orderable product code. A1 Product
and Product Code “UDI” symbol if there is more Identification
than one barcode on the final Labeling
product when it reaches the
customer.

Serial Number Unique number as defined by Same 4.3.8

manufacturer. For accessories
used with an IVD product, a
batch code can be used instead
of a serial number.

Intended Purpose IVD symbol, if applicable Same 4.3.13

System description, consistent DQSP-00080-
with trademark and product G1 Symbols
registration. Glossary

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Required Element General Requirement Minimum requirement References

for space-constrained (within this
application procedure)

Electrical Supply Allowable input voltages, or Same DQSP-00080-

voltage range. G1 Symbols
Glossary

AC or DC input.

Allowable input frequency or

range of frequencies.

Use of symbols for

voltage/frequency and range
units of measure is required.

Compliance Marking CE mark; for products sold in the Same DQSP-00080-

EU; with Notified Body number G1 Symbols
for IVDD Annex II products and Glossary
IVDR class B, C and D products.

Electrical Safety
Electrical/mechanical safety Standards as
compliance marking (UL, TUV, applicable
etc.) as required.

Patent/IP US Patent Number or appropriate Same 4.3.5

URL where patent number is
available, if applicable.

Usage Information “Refer to Instructions for Use” Same DQSP-00080-

symbol. G1 Symbols
Glossary

Date of Manufacture “Date of Manufacture” symbol Same DQSP-00080-

with date of manufacture (YYYY- G1 Symbols
MM or YYYY-MM-DD). Glossary

Laser Safety Laser classification as applicable. Same DQSP-00080-

G1 Symbols
Glossary

Electrical “WEEE” symbol (EU). DQSP- 00080-

Component Waste “EUP” Symbol (systems sold in G1 Symbols
and RoHS China). Glossary

Label Part Number Unique identifier to control Same N/A

version and use of labeling
artwork on product

4.2.2 Descriptive and Hazard Marking

If on-product marking is required to indicate system features, hazards or interfaces

with its user, utilities or other products, these markings and their meanings shall
be provided in a translated glossary with the system’s Instructions for Use.

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Where possible, descriptive and hazard marking shall be provided as normalized

symbols or pictograms, to aid in user recognition and reduce the need to localize
these markings. If text is required, unless it is part of normalized content (IEC
laser safety warnings, for example), this content shall be localized consistent with
regional requirements.

4.2.3 System Consumables and Supplies (not applicable to reagents)

The basic content requirements for system supplies and consumables labeling
are included in the summary table below. Examples of system consumables
include plastic disposables, such as cuvettes, reaction tubes or sealing caps.
Consumable components that are active parts of an analytical process, such as
single-use and multi-use electro-chemical sensors, shall follow the labeling
requirements found under the assay/reagent section as applicable.

This information may be applied directly to the container or the unit-of-sale

packaging.

Any handling, storage or usage information not conveyed through use of

harmonized symbols must be translated consistent with requirements of the
country the product is sold in. The meaning of any non-harmonized symbols
must be explained in the Instructions for Use.

As there are generally no labeling space issues with system consumables and
supplies supplied in bulk packaging, requirements have not been adjusted for
space- constraint.

Required Element General Requirement References

Manufacturer “Siemens” or “Siemens Healthineers” 4.4.2

logo and full Legal Manufacturers
address.

EC Authorized Full address of EC Authorized DQSP-00080-G2

Representative Representative, if the product is CE Legal Manufacturer
marked and the Legal Manufacturer is Address
located outside of the European
Union.

Country of Origin Origin: (Country code). 4.3.7

Product Name Unique proprietary name in English. 4.3.1

Compliance Marking CE mark, for products sold in the EU; 4.3.12

(if product or with Notified Body number for IVDD
accessory is a Annex II products and IVDR class B,
registered medical C and D products.
device)

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Required Element General Requirement References

System If product is used in combination with 4.3.4

a system, identify the system.

Unique Device UDI content (for registered devices) DQSP-00080-A1

Identification (UDI) and customer- orderable product Product Identification
and Product Code code. Labeling
“UDI” symbol if there is more than one
barcode on the packaging.

Batch/lot or serial Unique number as defined by 4.3.8

number manufacturer.

Contents Number of devices/components in N/A

package, mass or volume as
applicable.

Intended Purpose “IVD” symbol, if applicable. 4.3.13

System description, consistent with DQSP-00080-G1
trademark and product registration. Symbols Glossary

Reuse of supplies “Do not Reuse” symbol if applicable. DQSP-00080-G1

Symbols Glossary

Handling and If performance or use life is affected 4.3.10

Storage information by temperature, “Shipping/storage ” DQSP-00080-G1
temperature symbol with allowable Symbols Glossary
range.
Handling symbols: “Fragile”, “This
Side Up”, “Keep away from
Wet/Heat/Cold” as applicable.

Patent/IP US Patent Number or appropriate 4.3.5

URL identifying where the patent
number is available, if applicable,
recommended on device or immediate
container.

Usage information “Refer to Instructions for Use” symbol, DQSP-00080-G1

unless use is obvious and intuitive. Symbols Glossary

Use Life Date of product expiration, if the DQSP-00080-G1

performance of the product is affected Symbols Glossary
by age: “Expiration” symbol plus date
YYYY-MM-DD.

If no stated use life, date of

manufacture shall be included:“Date
of Manufacture” symbol with date of
manufacture (YYYY-MM).

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Required Element General Requirement References

Safety All safety warnings use graphics DQSP-00080-G1

symbols or are translated in the Symbols Glossary
required languages.

Label part Unique identifier to control version and N/A

numbering use of labeling artwork on product.

4.2.4 System and Accessory Packaging

The basic content requirements for the system packaging are included in the
summary table below. As there is generally no labeling space issues with system
or accessory packaging, requirements have not been adjusted for space-
constraint cases.

Required Element General Requirement References

Manufacturer “Siemens” or “Siemens Healthineers” 4.4.2

logo and full Legal Manufacturers
address.

EC Authorized Full address of EC Authorized DQSP-00080-G2

Representative Representative, if the product is CE Legal Manufacturer
marked and the Legal Manufacturer is Address
located outside of the European
Union.

Country of Origin Origin: (Country code) DQSP-00080-G2

Legal Manufacturer
Address

Product Name Unique proprietary name in English. 4.4.1

4.4.4
For Packages with multiple
components, description of items
contained.

System If product is used in combination with 4.4.4

a system, identify the system.

Unique Device UDI content (for registered devices) DQSP-00080-A1

Identification (UDI) and customer-orderable product code. Product Identification
and Product Code “UDI” symbol if there is more than one Labeling
barcode on the saleable product.

Serial Number Unique number as defined by 4.4.8

manufacturer.

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Required Element General Requirement References

Intended Purpose “IVD” symbol, if applicable. 4.4.13

System description, consistent with DQSP-00080-G1
trademark and product registration. Symbols Glossary

Compliance Marking CE mark; for products sold in the EU; 4.3.12

(if system or with Notified Body number for IVDD
accessory is a Annex II products and IVDR class B,
registered medical C and D products.
device)

Handling and safety Add shipping handling risk, including 4.3.10

information temp/humidity range, as applicable to DQSP-00080-G1
maintain product performance and Symbols Glossary
stability.

Usage information “Refer to Instructions for Use” symbol. DQSP-00080-G1

Symbols Glossary

Date of Manufacture “Date of Manufacture” symbol and DQSP-00080-G1

formatted date YYYY-MM. Symbols Glossary

Label part Unique identifier to control version and N/A

numbering use of labeling artwork on product.

4.2.5 Electronic / Software Media

The general content requirements for software media (including but not limited to
CD/DVD/Flash Drive) labeling are included in the summary table below. All
product identification content shall be marked on a permanent part of the media,
printed using permanent inks, label stocks and adhesive systems from compliant
marking systems.
Media devices which are too small to contain all information may have content
included on outer packaging or the instructions for use. See space- constrained
applications below.

Required Element General Requirement Minimum requirement References

for space-constrained
application

Manufacturer “Siemens” or “Siemens Siemens name 4.4.2

Healthineers” logo and full
Legal Manufacturers address.

EC Authorized Full address of EC Authorized on outer packaging DQSP-00080-G2

Representative Representative, if the product is Legal Manufacturer
CE marked and the Legal Address
Manufacturer is located outside
of the European Union.

Country of Origin Origin: (Country code) on outer packaging 4.3.7

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Required Element General Requirement Minimum requirement References

for space-constrained
application

Product Name Unique proprietary name in Same 4.3.1

English.

System If product is used in Same 4.3.4

combination with a system,
identify the system.

Unique Device UDI content (for registered DQSP-00080-A1

Identification (UDI) devices) and customer- Product
and Product Code orderable product code. Identification
“UDI” symbol if there is more Labeling
than one barcode on the
saleable product.

Serial Number or Unique number defined by Same 4.3.8

Batch/Lot Number manufacturer. Batch/Lot DQSP-00080-G1
number to be preceded by Symbols Glossary
“LOT” symbol.

Intended Purpose “IVD” symbol, if applicable. Same 4.3.13

DQSP-00080-G1
Symbols Glossary

CE Mark, if applicable, with on outer packaging 4.3.12

Compliance Marking Notified Body number for IVDD
(if product or accessory Annex II products, self-test
is a registered medical products, and medical devices
device) and for IVDR class, B, C & D
products.

Date of Manufacture The date when the source code Same N/A
was completed, for IVDD
Annex II and IVDR class C or D
Standalone Medical Device
Software on outer packaging.

Patent/IP US Patent Number or on outer packaging 4.3.5

appropriate URL identifying
where patent number is
available, if applicable.

Usage Information “Refer to Instructions for Use” Same DQSP-00080-G1

symbol. Symbols Glossary

Trademarks and Ownership of trademarks and on outer packaging 4.3.5

Copyright Notices copyrights.

Label Part Number Unique identifier to control Same, unless N/A

version and use of labeling information is directly
artwork on product. marked on product

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4.2.6 Content for System Instructions for Use

Instructions for Use (IFUs) are required for all IVD, consumables and
accessories. In many cases, instructions for use for consumables and supplies
are most effectively included as part of the system’s IFU.
All Instructions for Use shall be developed using a standardized sequence of
information topics, based on both regulatory and usability criteria. Determining
whether IFU content constitutes performance or usability claims is the
responsibility of the Regulatory Affairs function.

For Self-Test and CLIA-waived products, the IFU shall be written to audiences
with limited diagnostics training, and for Self-Test products, enabling a lay user
th
(for example, in US at a 7 grade reading level) to correctly and safely perform
the IVD test procedure, understand the IVD test results, and complete any
customer maintenance activity required to maintain product readiness and
performance.

The FDA has defined the following information sections for system instructions
for use that shall be provided, except where information is not applicable, or as
specified in requirements for a particular product class:
 The proprietary name and common name, if any.
 The model number included on the system’s UDI.
 The intended use or uses of the product and the type of procedure,
e.g. qualitative or quantitative
 The intended purpose
 Use or function
 Installation procedures and requirements
 Principles of operation
 Performance characteristics and specifications
 Operating instructions
 Calibration procedures, including equipment and/or materials
 Operational precautions and limitations
 Hazards
 Service and maintenance information
 Name and place of business of legal manufacturer
 Revision code and date of issuance of revision (YYYY-MM)

General Requirements for System Instructions for Use

Note: the section sequence below is optional

4.2.6.1 Manufacturer
To include full address of Legal Manufacturer, plus Siemens
Healthineers headquarters address and internet URL:

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Siemens Healthineers Headquarters

Siemens Healthcare GmbH
Henkestr. 127
91052 Erlangen Germany
Phone: +49 9131 84-0
siemens-healthineers.com

For products sold in the European Union, the name and address of the
manufacturer's EC Authorized Representative is required if the product
is CE marked and the legal manufacturer is not located within the EU.
Note: If the name and address of the EC Authorized Representative is
present on the outer packaging, they are not required to be in the
instructions for use.

4.2.6.2 Identification of the IVD system

The full proprietary name of the IVD system shall be provided.

When the name does not uniquely identify the IVD instrument, an
additional means of identification shall also be given. (Example: Model
Number, Catalogue number)

Separate instrument modules and/or software shall be identified by

name and, if applicable, version.

4.2.6.3 Table of Contents

4.2.6.4 Intended Use and Intended Purpose

The intended use and intended purpose of the IVD instrument shall be
described. Refer to section 4.3.13.

Benefits and limitations of the IVD medical device with respect to the
intended use shall be described. Medical use may be described, where
appropriate.

4.2.6.5 System installation

Instructions for installation of the IVD instrument shall be given when

the installation is intended to be carried out by the user. These
instructions are not necessary when the installation is carried out
exclusively by personnel of the manufacturer or their representatives.

Information on available accessories including proper connectivity shall

be provided. For example: computer interface, modules, optional
software, connectivity hardware.

A statement of specific warranty limitations or where such warranty

information can be obtained shall be provided. An example would be
statements of actions by users that invalidate the manufacturer's
warranty.
Site preparation prior to installation, for example;

a) Physical environment required for proper functioning;

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(Limits of humidity, temperature, vibration, magnetic fields, external

electrical influences, electrostatic discharge, pressure,
acceleration, thermal ignition sources, environmental noise,
proximity to air conditioning or heating ducts)

b) Space requirements and clearance limits;

c) Technical requirements (Load-bearing capacity, appropriate

utilities, voltage, water pressure)

d) Dimensions, mass;

e) Basic settings made by the manufacturer;

f) Consumption values; Electrical power, water.

g) Noise level generated by the instrument (in decibels);

h) Electromagnetic compatibility, emission, and immunity.

Action upon delivery, information shall be provided on the following:

a) Unpacking;

b) Checking delivery for completeness;

c) Checking for damage during transport.

Bringing into operation: (If user is responsible for setup)

a) Set-up process including procedural steps (Example: connection to

utilities, connection to necessary components)

b) Function checks by the user for proper installation/readiness.

4.2.6.6 Theory of operation

Overview of operating elements

Basic principles of the technology used in system operation shall be

given.

4.2.6.7 Functions
For each specific IVD system function, information shall be provided on
the following:

a) Subsystems and their purpose;

b) Functional specifications for major subsystems. (Example: a

sample pipette delivery volume is within ± 2 % relative volume
error from 5 μl to 20 μl; a reagent pipette dispenses within CV 2 %
from 50 μl to 200 μl).
4.2.6.8 Performance of the IVD instrument

Information shall be provided on the performance characteristics of the

IVD instrument.

Examples: Throughput, Carryover, Cross-contamination, Sample

volume, Absorbance linearity of photometer, Wavelength.

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4.2.6.9 Limitations of use

Information shall be provided on the limitations of use of the IVD

system. (Example: Sample viscosity, accessory compatibility, computer
connectivity)

4.2.6.10 Preparation prior to operation

a) Specific training of the user that is required;

b) Special materials and/or equipment required in order to use the IVD

instrument properly;

c) Ordering information for reagents and consumables;

d) Allowable types of sample containers;

e) Acceptable primary samples; whole blood, serum, plasma, urine,

spinal fluid, etc.

f) System checks for safe and correct operation, including calibration;

g) Hardware adjustments, if required.

4.2.6.11 Operating procedure

A detailed description of the procedure for performing the IVD

examination shall be provided. The procedure shall include all phases
of the operation from start-up to reading of results.

Abbreviated operating instructions, such as on a card to be attached to

the instrument, may be helpful to the user.

4.2.6.12 Control procedure

Adequate information about the performance of the IVD instrument and

a means to verify that it is performing within specifications shall be
provided. Note: Users are responsible for determining the appropriate
quality control procedures for their laboratory and for complying with
applicable laboratory regulations.

4.2.6.13 Calculation of examination results

The mathematical approach, when examination results are calculated

If the user must perform a calculation, an example calculation may aid

the user's understanding.

4.2.6.14 Special functions

Information on the following shall be provided, where appropriate:

a) Special function and specific performance checks

b) Automatic checks on the system

c) Primary sample identification

d) Data output, notation, storage, security and transfer

e) Special settings other than the normal mode of operation

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f) Interface protocol

4.2.6.15 Emergency primary samples

A procedure for inserting an emergency primary sample into the routine

operation shall be provided, as appropriate.

4.2.6.16 Storage and handling

Instructions relevant to any particular environmental requirements and

handling and/or storage conditions shall be given.

4.2.6.17 Warnings and precautions Information relevant to the following

shall be provided:

a) Residual risks related to installation, operation, maintenance,

transportation, storage or disposal of the IVD instrument and/or its
accessories. (Such as risks related to handling and disposal of
infectious or potentially infectious materials)

b) Known interferences that present significant risk

c) Electromagnetic compatibility, emission and immunity

4.2.6.18 Shut-down procedure Information shall be provided on the

following:

a) Placing the IVD instrument on stand-by

b) Switching the IVD instrument off

c) Temporarily taking the IVD instrument out of operation

4.2.6.19 Maintenance

a) Preventive maintenance to be performed by the user (nature and

frequency)

b) Instructions for cleaning to be performed by the user (compatible

materials, procedure, frequency)

c) Guidance on sterilization, decontamination or disinfection to be

performed by the user to ensure safe use and prior to an
intervention by the supplier or service personnel;

d) Components list, including relevant working materials and tools

e) Servicing contact information

f) Recommended spare parts and consumables to be replaced by the

user

4.2.6.20 Disposal information shall be provided on the safe disposal of

hazardous waste materials, accessories and instruments at their end of
life. (Examples: consumables, including those mixed with reagents or
samples; system, components and accessories)

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IFU should encourage users to check with local waste disposal

authorities for specific requirements.

4.2.6.21 Troubleshooting

a) Interpretation of malfunction messages

b) Determining causes of common malfunctions

c) Problems that can be corrected by the user

d) Problems that necessitate service calls

e) Actions to be taken in the event of a change in the performance
characteristics of the IVD instrument.
4.2.6.22 Follow-up action (for Self-Test Products) - Advice shall be given on
actions to be taken based on the IVD examination results, taking into
account the possibility of incorrect results. The information shall include
a statement directing the user not to make any decision of medical
relevance without first consulting his or her healthcare provider.

4.2.6.23 Technical Assistance (If required within the commercial business)

4.2.6.24 Definition of Symbols- All symbols used to convey product labeling

information on system, consumables, software media and accessories

4.2.6.25 References

4.2.6.26 Trademarks, Patents and Copyright Notices

4.2.6.27 Unique Document identifier to control version and its use with
specific product configurations. SMN, revision code and date of
issuance of revision (YYYY-MM).

Additional Requirements for System Instructions for Use, derived from IVDR
European Requirements

Under the Regulation (EU) 2017/746 of the European Parliament and of the council
of 5 April 2017, all instrument Instructions for Use for products imported into the
European Union must contain the following additional content:

4.2.6.28 Serious Incident Reporting Statement

A serious incident reporting statement shall be added instructing the
user to report serious incidents to the manufacturer and the competent
authority of the EU Member State in which the user and/or patient is
established.

4.2.6.29 Residual Risks

Residual risks required to be communicated to the user shall be

included as limitations, contraindications, precautions, or warnings.

4.2.6.30 Revision Information

A revision information section shall be added identifying new or updated

topics. Alternatively, change bars can be used to identify new or

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updated content. The revision information section or change bars shall

be included in all language IFUs.

4.2.6.31 Hardware, IT Network Characteristics and IT Security Measures

For devices that incorporate electronic programmable systems,

including software or standalone medical device software, minimum
requirements concerning hardware, IT network characteristics, and IT
security measures necessary to run the software as intended shall be
included in the instrument Instructions for Use.

4.2.6.32 CE Marking

For class B, C and D devices, the CE marking shall be followed by the

identification number of the notified body responsible for the conformity
assessment procedures.

4.2.6.33 Malfunction of the Device

Warnings, precautions, and/or measures to be taken shall be added to

the instructions for use in the event of malfunction of the device or its
degradation as suggested by changes in its appearance that may affect
performance.

4.3 General Labeling Content Requirements

4.3.1 Design and Usability

Design and construction of Product Labeling shall respect these design and
usability requirements:
 Critical-for-use content shall be provided in a type size of at least 7 points.
Such content includes product code, proprietary name, warnings or
precautions. Approved sans-serif type families shall be used. Use of smaller
font sizes in product labeling shall be evaluated first for legibility and usability.
Refer to Siemens corporate design guidelines for supported fonts and
application guidance (brandville.siemens.com).
 Data and parameters shall be expressed in measurement units required by the
countries that the product is sold in, in all cases including SI units. All data shall
be displayed with its unit of measure.
 Product and System names shall not be rendered as a logo or type-mark.
Adequate contrast of image to background shall be maintained for legibility.
 Product protection information shall be provided on the carton surfaces and
shall be visible in normal storage (for example, visible on the packaging surface
when product is in a refrigerator or on a shelf). Critical product information,
including risk and safety information shall be placed in a prominent and visible
position on the carton or component.

4.3.2 Company Logo and Company Name

The Siemens or Siemens Healthineers Logo shall be used on product marking,

packaging and IFU applications, unless the application is significantly space-
constrained. Logo placement, size, color, proportion, and use shall comply with
corporate design guidelines.

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If component labeling application is space-constrained so that the logo cannot be

used within its minimum size/placement requirements, the use of the Legal
Manufacturer’s address in approved typeface is an acceptable option, providing
that sales packaging and instructions for use carry the full branding and address.

The “Legal Manufacturer”, if not the actual manufacturer, is the entity that has
taken legal responsibility for the product’s sale and use. If Siemens is not the
Legal Manufacturer, the Siemens or Siemens Healthineers logo shall not be used
on product labeling or related customer documents.

4.3.3 Company Name in Product Labeling Text

After the prominent use of the full company name (in document text, any
subsequent references to the company may be shortened to “Siemens” or
“Siemens Healthineers”.

4.3.4 Product Name

The proprietary product name shown in the IFU and on outer container/unit of
sale labeling ensures correct and unique identification to the user. The name on
products shall align with the naming used in product registration and sales.
Reagent/Consumable components shall be uniquely identified so that they are
used properly. If a reagent or consumable name is not unique within Siemens,
the product name on outer container/unit of sale labeling and the IFU shall
include reference to the system or application that it is used with.

Example: ADVIA Centaur ® Total IgE or Dimension ® ISE Urine Diluent

Product and component proprietary names or trademarks are provided in English

only. Any common descriptive terms not part of the proprietary name that help to
clarify the product name or trademark shall be translated into local languages.

Examples:

®
Clinitek Microalbumin 9 (proprietary product name)
Reagent Strips for Urinalysis (descriptive phrase to be translated)
or
MultiCap (proprietary product name)
Blood collection capillary tubes (descriptive phrase to be translated)

In the case of a kit or similar assembly of components, each component shall be

identified and referred to in the same manner between labeling and instructions
for use.

4.3.5 Trademarks, Copyright and Patents

Both trademark and copyright notices should appear on all product labeling
documents that are published externally.

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Trademarks and Trademark Notice

Contact the Intellectual Property (IP) group to determine the strategy, use and
restrictions for product trademarks.

Any product trademarks or service marks displayed on packaging or

documentation, including customer documents shall indicate whether trademarks
are fully registered (®) or not (™).
The ® (registered trademark) or ™ (trademark) symbols are used the first time
that a Siemens trademark is used in a document or within a new chapter or
section of a document or instruction for use.

The Trademark notice must also appear as below for documents authored and
produced within the USA:
“(trademark A), (trademark B) and (trademark C) are trademarks of (Legal
Entity).
If third-party trademarks are used as part of the product or in product labeling,
the statement “All other trademarks and brands are the property of their
respective owners.” shall be included.
To determine trademark requirements of OEM-sourced or co-branded products,
contact the IP department for any contractual agreements or restrictions in use.
®
Do not use the ™ or with another company’s product name without first
contacting the IP group.

Copyright Notice

The copyright notice shall appear on all product manuals, instructions for use and
related technical documents distributed to customers. The copyright notice shall
appear as below:
© YYYY (Legal Entity). All rights reserved

For revised content from original copyright date:

© YYYY-UUUU (Legal Entity). All rights reserved
YYYY is original copyright date; UUUU is revised document copyright date.

Patent Marking

Patent Marking is the application of patent numbers (a) directly to products that
contain or incorporate patented features or aspects, or (b) indirectly to product
labeling, packaging or associated materials.

The purpose of Patent Marking is to inform the public of a product’s patented

status to enable the patent owner to collect damages for proven infringement as
of the date of first marking. In order to collect such damages, a product that is
made in, offered for sale in, sold in, or imported into the United States (US) is
required to be marked with the number(s) of any unexpired US patent(s) that
claim the product or any component thereof. Patent marking is not required for
US patents that contain only method or process claims.

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The IP department should be consulted to determine if new patent numbers need

to be added to, or numbers of expired patents need to be removed from,
products or associated labeling / packaging / documentation.

Direct marking of the product is recommended; however, if the nature or size of

the product precludes direct marking, indirect marking is permitted in the
following order:

 Tag or label that is directly applied to the product (e.g., with an adhesive)
 Immediate container for the product
 Other product packaging, product insert documentation, operator manual,
or documentation sold with and accompanying the product at sale.
 Applicable patent URL displayed on packaging and instructions for use.
Format Example:
 US Pat 4,745,181 (Single patent)
 US Pats 4,745,181; 4,918,192; D341,779 (Multiple patents)

Both the patent numbers and the application instructions are provided by the
IP Department.

4.3.6 Legal Manufacturer Address

All product labeling shall clearly identify the Legal Manufacturer by its full name
and address.

The Legal Manufacturer address must have these elements:

Number/House/Floor (as appropriate to site),
 Street / Road
 City, State / Region
 Country
 Postal Code

The CE-Norm “Manufacturer” symbol shall be provided adjacent the Legal

Manufacturer address block.

In addition to the address, the Siemens Healthineers URL shall be included for all
products

For space-constrained component labeling applications, the minimum

requirements to specify Legal Manufacturer are name, city, state (if USA),
country code and post code / zip code. In those applications, the full address
shall be printed on the sales carton and instructions for use.

There shall be alignment between the Legal Manufacturer address in product

labeling and the address in related regulatory, commercial, and quality
documents associated with the product.

If the product is CE marked and the Legal Manufacturer is located outside of the
European Union, the EC Authorized Representative name and address shall be
included adjacent the Legal Manufacturer address block on outer container/unit
of sale labeling and/or IFUs.

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If the name and address of the EC Authorized Representative is present on the

outer packaging, they are not required to be in the instructions for use.

4.3.7 Country of Origin

Many countries require a notification of Country of Origin for goods to comply

with local customs/import procedures. The Country of Origin determination is
made for each product individually, and for products with component from
multiple sources, it depends on where ‘substantial transformation’ occurs. The
Country of Origin two-letter country code preceded by the word “Origin:” shall be
provided as part of or adjacent to the UDI label, or near the Legal Manufacturer
address block on all sales/outer container labeling.

4.3.8 Manufacturing Information

Batch/Lot Code

A medical device’s point of manufacture shall be indicated on both component

and unit-of-sale products, this is usually provided through a Batch or Lot code.
This code is preceded by the “LOT” symbol.

The Batch/Lot number provided on the outer container shall be specific enough
to enable product history to be traced to individual components and production
processes in the manufacturer’s production file. For multi -component kits or bulk
packaging, there is no regulatory requirement to print individual Batch/Lot codes
on the outer package for all contained components. For lot marking of duplicated
software media, if there is no established lot code, it is recommended to use
numeric week/year of manufacture, in the format WWYYYY.

Use By / Expiration Date

All product components and unit-of-sale kits that have a defined use life shall
have a “use by” or “expiration” date on labeling, preceded by the “Expiration”
symbol (See Symbols Glossary). The date may be printed in one of four formats:
YYYY-MM (Year-Month): Expiration is assumed to be the last day of that month

YYYY-MM-DD (Year-Month-Day)

A legend “YYYY-MM-DD” printed near the date code is a useful tool for making
month/day order clear, due to regional conventions for month/day order. This is a
good practice but not a requirement.

The Expiration date printed on the outer container of components shall be the
date of the component having the earliest expiration date, or earlier if appropriate
to product use. There is no regulatory requirement to print expiration dates for
individual components on the outer unit-of-sale package.

For products that do not have a stated expiration date or use life, the date of
manufacture (YYYY-MM) shall be provided on the sales/kit packaging, marked
with the “Date of Manufacture” symbol. Alternatively, the date may be included as
part of the batch/lot code or serial number, provided the date portion is clearly
identifiable.

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4.3.9 Content, Number of Tests, Volume, Quantity

The physical contents of reagent components shall be indicated on the label.
Examples for providing this information include:
 “Contents” Symbol (see Symbols Glossary) with number (n) adjacent;
describing that the product contains sufficient supplies for (n) tests.
 Fluid Volume or Mass, providing the content in appropriate measurement
units (such as 500mL). For products that are reconstituted in situ, fluid volume
value shall be as reconstituted.

The contents of a unit-of-sale package shall be indicated on its labeling and

instructions for use. This shall include:

a. Description of items contained in package. This may take the form of

component symbols (see multiple-component kit example below) Refer to
4.5.1 for construction of Component Symbols.

i.

b. Quantity, proportion, or concentration of all active ingredients: e.g. weight per

unit volume, mg. /dL. For reagents derived from biological materials the
source and measure of its activity, e.g., bovine, I.U.
c.As applicable: buffers, preservatives, stabilizers (concentration is not required
for non-reactive ingredients).
d. As the description of ingredients is a requirement for IVD products in the US,
this information shall be placed within a “ For US/CA’ zone on the carton
packaging.
4.3.10 Transport, Storage and Handling information
Any conditions needed to adequately maintain product performance or maintain
the stability of the product in its unopened state shall be described on the
product packaging and IFU. These conditions could include temperature,
orientation, transit, or environmental limitations.

Storage Temperature

Labeling of components and unit-of sale packaging for products whose

performance or use life is affected by temperature shall include a storage
temperature range; expressed in degrees Celsius and used with the Storage
Temperature symbol. Refer to the Symbols Glossary for examples. This
temperature range shall be included in the IFU and be aligned to validated
product performance data.

Typical Storage Temperature ranges include:

–80°C to –60°C
–25°C to –10°C

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+2°C to +8°C
+15°C to +25°C

Room Temperature (ambient)

Products with Room Temperature / ambient storage conditions normally do not

require storage temperature labeling.

Transport and Environmental Risks

Any risk to performance or use life as a result of exposure to environmental

conditions while in transit to a customer’s site shall be identified on the unit of
sale packaging (if that is how the product is shipped to the customer) or shipping
container (typical for consolidated shipment of products).

Risks related to storage conditions at a customer’s site shall be defined on the

product packaging and IFU. On packaging, this is generally provided as symbols
from industry-supported standards; examples of information to protect the
product in storage include:
Fragile
Do not Freeze
Keep away from Light or Heat This Side Up

All symbols shall be explained in the reagent IFU and/or system manual.

GHS Chemical Risk/Safety Information

Chemical Risk and Safety classification and customer information is defined for a
reagent or consumable product by the EHS function. This information is aligned
to the chemical Safety Data Sheet developed and controlled by EHS. Risk
Management procedures are also used during the product lifecycle to identify
other potential material hazards.

The Globally Harmonized System of Classification and Labeling of Chemicals

(GHS) developed by the United Nations has been adopted into the new EU
Classification, Labeling and Packaging (CLP) regulations.

GHS Content Requirements:

GHS information shall be provided on the component label, sales/kit packaging

and Instructions for Use

Component (reagent pack/bottle/vial) and Sales/Kit Packaging

Requirements
 Hazard Graphic Symbol
For components, each symbol shall measure at least 1.4 cm across corners
unless labeling area available cannot accommodate placement of symbol.
Minimum symbol size for legibility in space-constrained component
placements is 7% of available label area. For example, on a 30x30 mm label,
the symbol may
2
be scaled to 63 mm or about 8 mm square, but legibility of the symbol must
be maintained in all cases.

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 For Sales/Kit Packaging, each symbol shall measure 1.4 cm across corners.

 Example:

 Signal Word, if the material is so classified: Danger or Warning, printed

adjacent the symbol on the component label and sales/kit packaging.

 For space-constrained component labeling applications, the minimum labeling

content required is the Hazard symbol.
 GHS Hazard and Precaution (H+P) codes shall be provided adjacent the
symbol on sales/kit packaging with Hazard codes listed first, followed by
Precaution codes. In some cases, chemical classifications require that only
H+P codes be provided on the carton with no associated warning symbol.

IFU and Manuals

 Hazard Graphic(s) and GHS Signal word if so classified: Danger or Warning,

printed adjacent the graphic.

 Hazard and Precaution code(s) and Hazard and Precaution statements(s) in

local language.

 EU Supplemental labeling information

• Statement(s) relating to particular physical or health property.

• Statement(s) for certain mixture(s).

If the product is not accompanied by instructions for use, the warning symbol(s),
signal word, H+P statements, and supplemental labeling shall either be included
on the label of the outer/unit-of-sale container or on another document supplied
with the product, translated into the languages appropriate for the market.

Guidance on the application GHS Hazard symbol, minimum and nominal sizing
and printing constraints is contained in Symbols Glossary.

4.3.11 Biological Hazards

A statement defining any biological hazards is required in the product IFU.

For product containing known biological hazards, the Biohazard symbol (see
Symbols Glossary) shall be printed on the component and outer container/unit of
sale labeling.

For human-sourced materials that represent a potential biohazard, the statement

shall comply with the Clinical and Laboratory Standards Institute (CLSI) standard
and current Centers for Disease Control and Prevention (CDC) guidelines on
precautions for prevention of HIV and other blood-born infections.
 The biohazard statement may vary in wording depending upon source
materials, but in all cases, these elements shall be included:

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 Source of biohazard (human/animal sera or viral). As applicable, statement

whether materials used came from sources with specific antibodies, or that
human sources have been tested for non-reactivity to specific viruses
 Statement that all source materials should be handled as potentially
infectious, and managed under good laboratory practices
 The ‘Biohazard’ symbol shall be included prior to these statements; guidance
on minimum and nominal sizing is found in the Symbols Glossary.
 Specific language describing Biological Hazards should be developed with the
support of EHS and RA functions as the content is dependent on biological
source and associated testing.
An example for products containing human source material:

Warning! Potential Biohazard

Contains human source material. Each donation of human blood or blood component
was tested by FDA-approved methods for the presence of antibodies to human
immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2) as well as for hepatitis B
surface antigen (HBsAg) and antibody to hepatitis C virus (HCV). The test results
were negative (not repeatedly reactive).
Caution
No test offers complete assurance that these or other infectious agents are absent;
this material should be handled using good laboratory practices and universal
precautions.

Animal Source

If there are animal-sourced ingredients in the reagent product (such as bovine

serum, mouse antibody, etc.), the following statement shall be included in
English and French, to comply with Canadian regulatory standards. Note: This
does not apply to antibodies/antigens cloned from animal source.

No biohazard symbol is used in this case.

Caution
This device contains material of animal origin and should be handled as a potential
carrier and transmitter of disease.

Human and Animal sources

When both human-sourced and animal-sourced ingredients are included in a

product, the Human Biohazard statement is provided in the IFU first, and the
Animal source statement to follow, but shall be treated in content as a hazard
separate and distinct from the human statement.

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4.3.12 CE Marking

All IVD products sold in the European Community shall either be self-certified by
the manufacturer or registered by a Notified Body.

Many IVD products must be registered in the EC prior to sale. If a product has
been registered and approved for sale by a Notified Body, the Notified Body’s
agency number (a four-digit numeric) is placed adjacent or below the CE mark.

The CE mark shall be applied to the registered medical device and it’s IFU. In the
case of IVD kits containing multiple components, the ‘medical device’ is the kit
itself, and the CE mark shall be applied to the kit’s outer/unit-of-sale packaging
and its IFU.

Consumables and accessories of CE-marked IVD systems are also CE-marked

on outer/sales packaging and applicable IFUs, this marking requires that those
products are also listed and referenced within the system’s IVDD Tech File.
Spare parts and non-IVD components are not CE marked, unless they have
been registered under another Directive (such as the Machinery or Low Voltage
Directive).

Minimum CE symbol height is 5 mm (0.20 in), not including accompanying

Notified Body number.

4.3.13 Intended Use and Intended Purpose

For assay and reagent products, the Intended Use statement is required on outer
packaging and IFUs. For Instruments and IVD Software, this information is
required in operating documentation supplied with the product.

For product IFUs this statement is comprised of these elements:

 IVD or other supported regulatory classification, with associated statements
 Test determination (quantitative, qualitative)
 Specific Analyte
 Valid Sample Type (such as Whole Blood, Serum, Plasma, Urines, CSF etc.)
 If an automated test, the system that the reagent is used with to complete
sample analysis (such as Dimension EXL)
 If applicable, the intended patient population validated for use
 Intended testing environment: Professional Use, Near Patient Testing or Self
Testing, as appropriate.

For product sales / outer packaging, the Intended Use statement shall include
these elements:
 IVD or other supported regulatory classification
 Specific Analyte
 If an automated test, the system that the reagent is used with to complete
sample analysis (such as ADVIA Centaur Systems)
This statement may be provided in English only on the outer container to meet
US requirements, as the full Intended Use statement is provided in the IFU

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translated into local languages. To show the fulfillment of US requirements, this

statement shall be located within a highlighted area marked “For US/CA”.
US-registered IVD assays are required to include a Prescription Use Only
statement as part of Intended Use. This may be accomplished either through use
of an “RxOnly” mark on the kit/sale packaging or the use of the statement below
in the IFU:

“Caution: Federal (USA) law restricts this device to sale by or on the order of a
licensed healthcare professional.”
The RXOnly symbol or statement on the kit or IFU shall be clearly indicated as a
US- only requirement and it may be positioned within a designated “For US/CA”
content area of the package.

For assay and reagent products, the Intended Purpose is required in the
instructions for use. For product IFUs the Intended Purpose is comprised of
these elements. The elements of the intended purpose do not necessarily have
to be together in the IFUs.

 The function (e.g. aid to diagnosis, diagnosis, diagnosis, monitoring, etc.)

 In context with (e.g. physiological or pathological status, congenital physical

impairment, prediction of treatment response, etc.)

 Automated or not

 Quantitative, semi-quantitative or qualitative

 Testing population

 Type of specimen

For assay and reagent products, the Intended Purpose is required on product
packaging unless the “IVD” symbol and product name are on the packaging.

Additional Requirements for Self-Test and Near-Patient Test Products

 For Self-Test products, a statement that the product is intended for self-
testing shall be provided. For IVDR CE marked Near-Patient Test products, a
statement that the product is intended for near-patient testing shall be
required. For IVDR CE marked products, self-test and near-patient test
symbols may be used on the packaging in place of text.

 For IVDR CE marked product, rapid tests which are not intended for self-
testing or near-patient testing shall indicate this. “Not intended for self-testing”
and “Not intended for near-patient testing” symbols may be used on the
packaging in place of text.

If the intended use is not indicated by the name of the IVD reagent, then an
abbreviated intended use statement shall be given on the product or included in
the instructions for use in terminology and local language suitable for a lay
person (Example: Pregnancy Test). Medical use and limitations of use shall be
described where appropriate and written for lay audience. (Example: Self-testing
of cholesterol, suitable for the demonstration of an elevated cholesterol but not
for its monitoring)

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For Regulatory Classification and associated statements in product labeling, refer

to table below

Regulatory Statement in IFU and carton label

classification

IVD For in vitro diagnostic use, with conditions above. For packaging, use with
either “IVD” symbol or translate IVD statement in all supported EC languages
For Self-Test products, The in vitro diagnostic use of the reagent shall be
indicated in terminology and local language suitable for a lay person
(Example: Only for use outside the body.)

IUO (USA) For Investigational Use Only. The performance characteristics of this
product have not been established . (prominently placed)

PEO For Performance Evaluation Only (in local language or with “IVD
(equivalent to Performance Evaluation Only” symbol)
IUO for EC Device for Performance Study
countries)

RUO For Research Use Only. Not for use in diagnostic procedures. (in local
language)

ASR (US only)

Analyte Specific Reagent: Analytical and performance characteristics
are not established. (English only). Note: no instructions for use are
provided with ASR products

GPR No special statement for use, but no performance claims are included with
product or IFU

Intended Use statement for a primary IVD reagent product may follow the structure in this
example:
For in vitro diagnostic use in the (test type) determination of (analyte) in (sample type) using the
(name of system). For Professional Use.

For a calibrator product, the structure of the Intended Use statement may follow this
example:
For in vitro diagnostic use in the calibration of (analytical test) using the (name of system). For
Near Patient Testing and Professional Use.

For a quality control product, the structure of the Intended Use statement May follow this
example:
For in vitro diagnostic use to monitor the (precision and the accuracy) of (analytical test)
procedures using the (name of system). For Professional Use.

For an IVD reagent product or consumable that is part of an analytical procedure, and does
not produce a diagnostic result directly, (such as diluent, plastic disposable or wash
solution), the Intended Use statement should follow this example:
For in vitro diagnostic use with the (name of system)

In all cases, for professional-use IVD reagent products sold in the Americas region and in
the EC, this statement may be provided in English only on the carton, if used with the ‘IVD’
symbol and ‘Consult Instructions for Use’ symbol. Translated intended use statements are
required in the product IFU.

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Performance Evaluation Only, Device for Performance Study and Investigational Use Only
products distributed in the EC and US shall include the appropriate statement above in
English, and the appropriate symbol.

For Self-Test IVD products, the Intended Use statement shall contain the same elements as
above but be provided in terminology and language suitable for a lay person. For example,
For in vitro diagnostic use could be expressed as Only for use outside the body.

The fact that the IVD reagent is intended for self-testing shall be clearly stated on the
sales/outer carton and IFU.

4.3.14 Country-specific Labeling Requirements: United States

For assay unit of sale packaging, Intended Use statement and Contents
descriptions are required. This shall be contained in a “For US” area of
packaging, and this information shall be in English only.

4.3.15 Country-specific Labeling Requirements: Australia

Australian Registration
All Self-Test IVD devices in Australia require the local sponsor (legal entity) name
and address in the instructions for use, and on the outer packaging

4.3.16 Country-Specific Labeling Requirements: Canada

All labeling on medical devices imported into Canada must be legible,
permanent, and prominent, and must contain the following minimum data:
 The name of the device.
 The name and address of the manufacturer.
 In the case of Class III or IV devices, the control number.
 If the contents are not readily apparent, an indication of what the package
contains.
 The word "Sterile" if the manufacturer intends the device to be sold in a
sterile condition.
 The expiry date of the device.

 Unless self-evident to the intended user, the medical conditions, purposes

and uses for which the device is manufactured. This must be in the
instructions for use.

 The instructions for use and storage.

For assay unit of sale packaging, a contents description is required. This shall be
contained in a “For CA” area of packaging, and this information may be in
English only.

Component and kit labeling shall be in English, Instructions for Use must be
supplied in both English and French.

Test Kit Registration

Products to be distributed in Canada shall be reviewed by the Siemens

Healthcare Canada RA group to identify any controlled substances in the reagent
formulation. If a controlled substance is identified, the product shall be registered

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in Canada and a Test Kit (TK) number assigned for each product configuration.
The format for this number is T.K. 00-00.

Contact RA or EHS representatives to determine if a product requires TK

registration.

The product sales/outer packaging shall include the TK number; if the TK number
is not available at the time of printing for product release, space should be
allocated on the package for imprinting the number in future.

Animal-Sourced Materials: refer to Biological Hazard information 4.3.11

4.4 Symbols and the Symbols Glossary

Symbols have been increasingly used to replace translated text in product labeling. A set
of approved standardized symbols and associated meanings is provided in DQSP-
00080-G1 Symbols Glossary. All symbols conveying product usage or safety information
shall be described in a Symbols Glossary contained in the product IFU. This glossary
shall have the symbol definitions translated into local languages as applicable.

The FDA and EU have defined a subset of graphical symbols that do not strictly require
a glossary definition, but developers should consider usability and risk in any decision to
delete these definitions in the product’s Symbol s Glossary.
Any symbol or identification color used shall conform to the harmonized standards. In
areas for which no harmonized standards exist, the symbols and color usage shall be
described in the Instructions for Use.

4.4.1 Component Names and Symbols

Reagent components shall be consistently identified in all forms of labeling for

the product; by name, letter, symbol, color or other means,

Certain descriptive names for reagents and consumables may be replaced with
component symbols, satisfying the needs for translated terms in many markets.
The symbol meanings are provided to customers via the Symbols Glossary on in
the body text of the product IFU or manual. The construction of these symbols
has been based on CE-Norm symbols in use.

Symbols may be used if the clarity or understanding of the reagent or component

name is not compromised.

Symbols or graphic elements may solely be used as the reagent or component

identifier on space-constrained packages if they provide a unique identity so that
the product cannot be confused with other products. The complete name, for
clarity and user reference, is required in the Instructions for Use (IFU).

Process for Construction of Proprietary Component Symbols

See examples in DQSP-00080-G1 Symbols Glossary.

a. Identify the basic reagent / consumable term or ‘root’ for the component
(such as calibrator, control, diluent, and cuvette).
b. Create an abbreviated version for that root; refer to current symbol
glossaries for current/standardized component root terms where possible.

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As guidance, this abbreviation should generally not be more than 7

characters and ideally should not have a direct meaning in any languages.
c. Place abbreviation in rectangular box that has the specified size, shape
and line weight;
d. If additional information is needed to better identify the component, place
this as a modifier within a separate box to the right component symbol box.
Standard chemical symbols and SI measurement terms and symbols may
be used as needed.
For example:

A composite symbol may be composed of terms within a maximum of three

boxes.

Recommended formatting of component symbols:

 Minimum symbol box height: 2.5 mm (0.10 in)
 Recommended minimum type size: 5.5 pt, all upper case
 Symbol / text alignment: all information within the box should be centered
4.4.2 “Refer to Instructions for Use” Symbol
If the information contained on the product or its outer packaging is insufficient to
correctly and safely use the product, the ‘Refer to Instruction for Use’ symbol
shall be included on both the products and packaging. If product use or
performance is related to a particular version of the IFU, then the version is
marked to the side or below this symbol. Refer to the Symbols Glossary
attachment.

For product lines utilizing electronic delivery of IFUs, an “eIFU Indicator” shall be
provided on product sales/kit packaging, including access URL for downloading
the IFU and indication of the correct IFU version to use with the product.

4.5 Product Hazards, Warnings and Caution statements

Product Risk Management procedures are used throughout the product lifecycle to
identify product hazards, and if necessary, define safety or operation information
delivered as part of product labeling to reduce risk to an acceptable level.

Warning or cautionary statements are included on product labeling and in product

Instructions for Use to inform users of potential risks and possible outcomes associated
with use or foreseeable misuse of the product.

These statements shall be provided clearly, completely, and legibly in the product
labeling. Product safety warning instances and classifications may be distinct from
chemical safety warnings defined by GHS.

4.5.1 Warning Statements

Warning statements indicate the risk of personal injury or loss of life if operating
procedures and practices are not strictly observed.

According to the FDA definition, a warning alerts the reader about a situation
which, if not avoided, could result in death or serious injury. It may also describe

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potential serious adverse reactions and safety hazards in normal use or under
foreseeable misuse.
The term “WARNING” is used as the signal word for this type of hazard alert and
regulatory agencies may expect that this warning is emphasized by placing it
within a ruled outline or highlighted box.

The term “WARNING” and associated information is translated in the IFU in local
languages.

4.5.2 Precautionary Statements

A precautionary statement generally warns the reader of a potentially hazardous

situation which, may result in minor or moderate injury to the user or patient or
damage to the equipment, data or other property if operating procedures and
practices are not strictly observed. It may also be used to alert against unsafe
practices or foreseeable misuse of the product.

The word “CAUTION” is used as the signal word for a precaution statement. The
distinction between warnings and precautions is a matter of degree of likelihood
and seriousness of the hazard.

The term “CAUTION” and associated information are translated in the IFU in
local languages

5.0 Terms
The definitions for these words can be found in the Diagnostics Glossary of Terms App or in
DQSP-00021-A2 Diagnostics Glossary of Terms and Glossary Guidance.

1. Accessory
2. Analyte-Specific Reagent (ASR)
3. Component
4. General Purpose Reagent (GPR)
5. Instructions for Use (IFU)
6. In vitro Diagnostic (IVD) Medical Device
7. Investigational Use Only (IUO)
8. Kit
9. Label
10. Medical Device
11. Outer Container (sales packaging)
12. Product Code
13. Product Labeling
14. Professional Use
15. Research Use Only (RUO)
16. Self-Testing
17. SMN

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Healthcare Diagnostics – Procedure

Document Name: DQSP-00080

Document Title: Product Labeling Procedure
Effective Date: 15-Apr-2021 Version: 8.0

6.0 Appendices
None

7.0 Required Documents (includes forms, templates, attachments)

 DQSP-00080-A1 Product Identification Labeling

8.0 References/Support Documents

 DQSP-00001 Siemens Healthcare Diagnostics Quality Manual (and references therein)
 Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on
in vitro medical devices (IVD Regulation)
 DQSP-00017 Risk Management Process
 DQSP-00080-G1 Symbols Glossary
 DQSP-00080-G2 Manufacturing Address Cases

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