MDR Conformity

Assessment Routes
 Contents

2 Class Is/Im/Ir devices 11 Custom-made Class III

implantable devices

3 Class IIa devices

12 Custom-made devices
(Excluding custom-made
5 Class IIb Annex VIII
Rule 12 devices
Class III implantable edvices)

Class I devices
(Excluding Class Is, Ir, Im
6 Class IIb implantable WET devices)
Class IIb non-implantable
non Rule 12 non WET
13 How BSI supports your
Medical Devices launch

8 Class IIb implantable devices

(Excluding WET)
CE Excellence

9 Class III non-implantable

devices

10 Class III implantable

devices

DISCLAIMER:

Information presented in the conformity assessment flow charts and tables below is based on our current
understanding of the MDR requirements at the time of publishing this document; subject to change. The tables
do not cover assessments under the conformity routes Annex X (Type Examination) and Annex XI, Part B (Product
Verification) which may require additional tests or examinations of the devices. The tables present a generalization
of the requirements based on the classification of devices and some exceptions may apply.

MDR Conformity Assessment Routes 1

@2024 BSI. All rights reserved.

Class Is/Im/Ir devices Applicable audits, assessments and requirements
Class Is/Im/Ir devices

Initial Surveillance
Class Is/Im/Ir Conformity
devices Assessment Y1 Y2 Y3 Y4 Y5

Class Annex II and III QMS Audits Yes Yes Yes Recert** Yes Yes

Is, Im, Ir** Technical

Documentation Microbiology Audits Yes* N/A N/A Yes* N/A N/A

No stand-alone Technical Documentation assessment. However, parts

Technical Documentation of Technical Documentation relevant to sterilization/metrology/re-use
Assessment aspects may be audited as part of QMS/Microbiology audits.

Clinical Evaluation Consultation

N/A N/A N/A N/A N/A N/A
Procedure (Article 54)

Consultations
N/A N/A N/A N/A N/A N/A
Annex XI* – Part A (Rule 14, Rule 18, Rule 21)
Annex IX* QMS
Production Quality
Chapters I, III Summary of Safety and Clinical
Assurance N/A N/A N/A N/A N/A N/A
Performance (Article 32)

Updated as per manufacturer’s clinical evaluation

Clinical Evaluation Report updates
plan.

Updated as per manufacturer’s PMS, PMCF plans.

Post Market Clinical Follow-Up Update Report Notified Body QMS audits to verify implementation
(Article 61) of the plan by sampling complaints, vigilance
Declaration of conformity information etc.
(Annex IV)
Post Market Surveillance (PMS) Report Updated when necessary and made available to
(Article 80) the Notified Body upon request.

Periodic Safety Update Report (Article 86) N/A N/A N/A N/A N/A

Unannounced Audits At least once every 5 years.

CE marking * If sterile or re-usable surgical instruments.

(Annex V) ** The Y3 “Recert” indicated in the table refers to the recertification audit related to EN ISO 13485:2016 certificate cycle which is typically three years. Most
manufacturers with MDR/IVDR certificates also hold EN ISO 13485 certificate.
CE 2797

** C
 lass Ir (Class I re-usable
surgical instruments)

* L
 imited to sterility, metrology
or re-use aspects as applicable
MDR Conformity Assessment Routes 2

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Class IIa devices Applicable audits, assessments and requirements
Class IIa non-implantable devices

Initial
Class IIa Conformity
Surveillance
non-implantable devices Assessment Y1 Y2 Y3 Y4 Y5

QMS Audits Yes Yes Yes Recert** Yes Yes

Class IIa Microbiology Audits Yes* N/A N/A Yes* N/A N/A

At least one Technical Documentation surveillance

Technical Documentation Sample per assessment is required every year. Assessments
Assessment category of devices carried out as per the Technical Documentation
Sampling Plan.

Clinical Evaluation Consultation

Annex XI – Part A N/A N/A N/A N/A N/A N/A
Annex XI – Part B Procedure (Article 54)
Annex IX QMS
Production Quality Production
Chapters I, III Consultations
Assurance Verification N/A N/A N/A N/A N/A N/A
(Rule 14, Rule 18, Rule 21)

Summary of Safety and Clinical

Performance (Article 32)
N/A N/A N/A N/A N/A N/A

Annex IX Chapter II Annex II and Annex III

Technical Documentation Technical Documentation
Updated as per manufacturer’s clinical evaluation
Assessed per device catagory Assessed per device catagory Clinical Evaluation Report updates plan. Notified Body to review as per Technical
Documentation Sampling Plan.

Updated as per manufacturer’s PMS, PMCF

Post Market Clinical Follow-Up Update Report
plans. Notified Body to review as per Technical
(Article 61)
Documentation Sampling Plan.

PSUR update required at least once every 2

Declaration of conformity Periodic Safety Update Report (Article 86) years. Notified Body to review as per Technical
Documentation Sampling Plan.
(Annex IV)
Unannounced Audits At least once every 5 years.

* If sterile or re-usable surgical instruments.

** The Y3 “Recert” indicated in the table refers to the recertification audit related to EN ISO 13485:2016 certificate cycle which is typically three years. Most
manufacturers with MDR/IVDR certificates also hold EN ISO 13485 certificate.

Continues on page 4
CE marking
(Annex V)
CE 2797

MDR Conformity Assessment Routes 3

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 Applicable audits, assessments and requirements
Class IIa implantable devices

Initial Surveillance
Class IIa Conformity
implantable devices Assessment Y1 Y2 Y3 Y4 Y5

QMS Audits Yes Yes Yes Recert** Yes Yes

Microbiology Audits Yes* N/A N/A Yes* N/A N/A

At least one Technical Documentation surveillance

Technical Documentation Sample per assessment is required every year. Assessments
Assessment category of devices carried out as per the Technical Documentation
Sampling Plan.

Clinical Evaluation Consultation

N/A N/A N/A N/A N/A N/A
Procedure (Article 54)

Consultations
N/A N/A N/A N/A N/A N/A
(Rule 14, Rule 18, Rule 21)

Updated at least annually “if indicated”. Notified

Summary of Safety and Clinical
Yes Body to review as per Technical Documentation
Performance (Article 32)
Sampling Plan or at the time of PSUR assessments.

Updated as per manufacturer’s clinical evaluation

plan. Notified Body to review updates as per
Clinical Evaluation Report updates
Technical Documentation Sampling Plan or at the
time of PSUR assessments.

Updated at least annually. Notified Body to review

Post Market Clinical Follow-Up Update Report
as per Technical Documentation Sampling Plan or at
(Article 61)
the time of PSUR assessments.

Updated when necessary and at least every two

Periodic Safety Update Report (Article 86) years. submitted to Notified Body via EUDAMED for
Notified Body review.

Unannounced Audits At least once every 5 years.

* If sterile or re-usable surgical instruments.

** The Y3 “Recert” indicated in the table refers to the recertification audit related to EN ISO 13485:2016 certificate cycle which is typically three years. Most
manufacturers with MDR/IVDR certificates also hold EN ISO 13485 certificate.

MDR Conformity Assessment Routes 4

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Class IIb Annex VIII Rule 12 devices Applicable audits, assessments and requirements
Class IIb Annex VIII Rule 12 devices

Annex VIII Rule 12 devices – All active devices intended to administer and/or remove medicinal products,
body liquids or other substances to or from the body.

Class IIb Class IIb

Initial
Conformity
Surveillance

Annex VIII Annex VIII Rule 12 devices Assessment Y1 Y2 Y3 Y4 Y5

Rule 12 devices QMS Audits Yes Yes Yes Recert** Yes Yes

Microbiology Audits Yes* N/A N/A Yes* N/A N/A

At least one Technical Documentation surveillance

Annex IX QMS Annex X Technical Documentation Sample per assessment is required every year. Assessments
Assessment generic device group carried out as per the Technical Documentation
Chapters I, III Type Examination Sampling Plan.

Clinical Evaluation Yes, but exemptions

May be required if any modifications to the device
Consultation Procedure may apply as per
adversely affect the risk-benefit ratio.
(Article 54) Article 54.2

Consultations
Annex IX Chapter II Annex XI – Part A Annex XI – Part B (Rule 14, Rule 18, Rule 21)
N/A N/A N/A N/A N/A N/A
Technical Documentation Production Quality Production
Assessed per generic device group Assurance Verification Summary of Safety and Clinical
N/A N/A N/A N/A N/A N/A
Performance (Article 32)

Clinical Evaluation Updated as per manufacturer’s clinical evaluation

Consultation Procedure Clinical Evaluation Report updates plan. Notified Body to review updates as per
Annex IX Sec. 5 / Annex X Sec. 6 Technical Documentation Sampling Plan.

Updated as per manufacturer’s PMCF plan

Post Market Clinical Follow-Up Update Report
Notified Body to review updates as per Technical
(Article 61)
Documentation Sampling Plan.
Declaration of conformity
(Annex IV) Periodic Safety Update Report
Updated at least annually. Notified Body to review
updates as per Technical Documentation Sampling
(Article 86)
Plan.

Unannounced Audits At least once every 5 years.

* If sterile or re-usable surgical instruments.

CE marking ** The Y3 “Recert” indicated in the table refers to the recertification audit related to EN ISO 13485:2016 certificate cycle which is typically three years. Most
manufacturers with MDR/IVDR certificates also hold EN ISO 13485 certificate.
(Annex V)
CE 2797

MDR Conformity Assessment Routes 5

@2024 BSI. All rights reserved.

 Applicable audits, assessments and requirements
Class IIb implantable WET Class IIb implantable WET, ClassIIb non-implantable non Rule 12 non WET
Class IIb non-implantable non Rule 12 non WET
Well-Established Technologies (WET) - sutures, staples, dental fillings and braces, tooth crowns, screws,
wedges, plates, wires, pins, clips & connectors as per Article 52 of MDR.

Class IIb Initial Surveillance

Class IIb Conformity
implantable WET implantable WET devices Assessment Y1 Y2 Y3 Y4 Y5

Class IIb QMS Audits Yes Yes Yes Recert** Yes Yes

non-implantable Microbiology Audits Yes* N/A N/A Yes* N/A N/A

non Rule 12
non WET At least one Technical Documentation surveillance
Technical Documentation Sample per assessment is required every year. Assessments
Assessment generic device group carried out as per the Technical Documentation
Sampling Plan.

Annex IX QMS Annex X

Clinical Evaluation Consultation
Chapters I, III Type Examination Procedure (Article 54)
N/A N/A N/A N/A N/A N/A

Consultations
(Rule 14, Rule 18, Rule 21)
N/A N/A N/A N/A N/A N/A

Updated at least annually “if indicated”. Notified

Annex IX Chapter II Annex XI – Part A Annex XI – Part B Summary of Safety and Clinical
Yes
Body to review updates as per Technical
Performance (Article 32) Documentation Sampling Plan or at the time
Technical Documentation Production Quality Production of PSUR assessments.
Assessed per generic device group Assurance Verification

Updated as per manufacturer’s clinical evaluation

Clinical Evaluation Report updates plan. Notified Body to review as per Technical
Declaration of conformity Documentation Sampling Plan.
(Annex IV)
Updated at least annually. Notified Body to review
Post Market Clinical Follow-Up Update Report
updates as per Technical Documentation Sampling
(Article 61)
Plan or at the time of PSUR assessments.

Updated at least annually. Submitted to Notified

Periodic Safety Update Report
Body via EUDAMED for Notified Body review
(Article 86)
CE marking (assuming WET devices are implantable devices).

(Annex V) Unannounced Audits At least once every 5 years.

CE 2797 * If sterile or re-usable surgical instruments.
** The Y3 “Recert” indicated in the table refers to the recertification audit related to EN ISO 13485:2016 certificate cycle which is typically three years. Most
manufacturers with MDR/IVDR certificates also hold EN ISO 13485 certificate.

Continues on page 7

MDR Conformity Assessment Routes 6

@2024 BSI. All rights reserved.

 Applicable audits, assessments and requirements
Class IIb non-implantable non WET non Rule 12 devices

Class IIb Initial Surveillance

non-implantable non-WET Conformity
Assessment Y1 Y2 Y3 Y4 Y5
non-Rule 12 devices

QMS Audits Yes Yes Yes Recert** Yes Yes

Microbiology Audits Yes* N/A N/A Yes* N/A N/A

At least one Technical Documentation surveillance

Technical Documentation Sample per assessment is required every year. Assessments
Assessment generic device group carried out as per the Technical Documentation
Sampling Plan.

Clinical Evaluation Consultation

N/A N/A N/A N/A N/A N/A
Procedure (Article 54)

Consultations
N/A N/A N/A N/A N/A N/A
(Rule 14, Rule 18, Rule 21)

Summary of Safety and Clinical

N/A N/A N/A N/A N/A N/A
Performance (Article 32)

Updated as per manufacturer’s clinical evaluation

Clinical Evaluation Report updates plan. Notified Body to review as per Technical
Documentation Sampling Plan.

Updated as per manufacturer’s PMCF plan.

Post Market Clinical Follow-Up Update Report
Notified Body to review updates as per Technical
(Article 61)
Documentation Sampling Plan.

Updated at least annually. Notified Body to review

Periodic Safety Update Report
updates as per Technical Documentation Sampling
(Article 86)
Plan.

Unannounced Audits At least once every 5 years.

* If sterile or re-usable surgical instruments.

** The Y3 “Recert” indicated in the table refers to the recertification audit related to EN ISO 13485:2016 certificate cycle which is typically three years. Most
manufacturers with MDR/IVDR certificates also hold EN ISO 13485 certificate.

MDR Conformity Assessment Routes 7

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 Class IIb implantable devices Applicable audits, assessments and requirements
Excluding WET Class IIb implantable non-WET devices

Initial Surveillance
Class IIb Conformity
implantable non-WET devices Assessment Y1 Y2 Y3 Y4 Y5

Class IIb QMS Audits Yes Yes Yes Recert** Yes Yes

Microbiology Audits Yes* N/A N/A Yes* N/A N/A

implantable devices
non WET Technical Documentation Review for every
N/A N/A N/A N/A N/A
Assessment device

Clinical Evaluation Consultation

N/A N/A N/A N/A N/A N/A
Procedure (Article 54)

Annex IX QMS Annex X Consultations

Type Examination N/A N/A N/A N/A N/A N/A
Chapters I, III (Rule 14, Rule 18, Rule 21)

Updated at least annually “if indicated”. Notified

Summary of Safety and Clinical
Yes Body to review at the time of PSUR reviews or sub-
Performance (Article 32)
stantial change reviews.

Annex IX Chapter II Annex XI – Part A Annex XI – Part B Updated as per manufacturer’s clinical evaluation
Clinical Evaluation
Technical Documentation Production Quality Production Report updates
plan. Notified Body to review at the time of PSUR
for every device reviews or substantial change reviews.
Assurance Verification
Updated at least annually. Notified Body to review
Post Market Clinical Follow-Up Update Report
at the time of PSUR reviews or substantial change
(Article 61)
reviews.

Periodic Safety Update Report Updated at least annually. Submitted to Notified

Declaration of conformity (Article 86) Body via EUDAMED for Notified Body review.
(Annex IV)
Unannounced Audits At least once every 5 years.

* If sterile or re-usable surgical instruments.

** The Y3 “Recert” indicated in the table refers to the recertification audit related to EN ISO 13485:2016 certificate cycle which is typically three years. Most
manufacturers with MDR/IVDR certificates also hold EN ISO 13485 certificate.

CE marking
(Annex V)
CE 2797

MDR Conformity Assessment Routes 8

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 Class III non-implantable devices Applicable audits, assessments and requirements
Class III non-implantable devices

Including devices with medicinal substances, human tissue or animal tissue derivatives with TSE
risk, Class III Rule 21 devices.

Class III Initial Surveillance

non-implantable
Class III Conformity
non-implantable devices Assessment Y1 Y2 Y3 Y4 Y5
devices
QMS Audits Yes Yes Yes Recert** Yes Yes

Microbiology Audits Yes* N/A N/A Yes* N/A N/A

Annex IX QMS Annex X Technical Documentation Review for every

N/A N/A N/A N/A N/A
Chapters I, III Type Examination Assessment device

Clinical Evaluation Consultation

N/A N/A N/A N/A N/A N/A
Procedure (Article 54)

Modifications to the devices may need

Consultations supplementary consultations; determined on a case-
If applicable
Annex IX Chapter II Annex XI – Part A Annex XI – Part B (Rule 14, Rule 18, Rule 21) by-case basis taking into account the nature of the
changes proposed.
Technical Documentation Production Quality Production
for every device Assurance Verification Updated at least annually “if indicated”. Notified
Summary of Safety and Clinical
Yes Body to review at the time of PSUR reviews or
Performance (Article 32)
substantial change reviews

Consultation
2001/83/EC, EC/726/2004,
Updated as per manufacturer’s clinical evaluation
2004/23/EC, EU/722/2012 Clinical Evaluation Report updates plan. Notified Body to review at the time of PSUR
reviews or substantial change reviews.

Updated at least annually. Notified Body to review

Post Market Clinical Follow-Up Update Report
at the time of PSUR reviews or substantial change
Declaration of conformity (Article 61)
reviews.
(Annex IV)
Periodic Safety Update Report Updated at least annually. Submitted to Noitified
(Article 86) Body via EUDAMED for Notified Body review.

Unannounced Audits At least once every 5 years.

CE marking * If sterile or re-usable surgical instruments.

** The Y3 “Recert” indicated in the table refers to the recertification audit related to EN ISO 13485:2016 certificate cycle which is typically three years. Most
(Annex V) manufacturers with MDR/IVDR certificates also hold EN ISO 13485 certificate.

CE 2797

MDR Conformity Assessment Routes 9

@2024 BSI. All rights reserved.

 Class III implantable devices Applicable audits, assessments and requirements
Class III implantable devices

Including devices with medicinal substances, human tissue or animal tissue derivatives
with TSE risk, Class III Rule 21 devices.

Class III Class III

Initial Surveillance
implantable devices Conformity
implantable devices Assessment Y1 Y2 Y3 Y4 Y5

QMS Audits Yes Yes Yes Recert** Yes Yes

Microbiology Audits Yes* N/A N/A Yes* N/A N/A

Annex IX QMS Annex X Technical Documentation Review for every

Type Examination N/A N/A N/A N/A N/A
Chapters I, III Assessment device

Yes, but exemptions

Clinical Evaluation Consultation May be required if any modifications to the device
may apply as per
Procedure (Article 54) adversely affect the risk-benefit ratio.
Article 54.2

Modifications to the devices may need

Consultations supplementary consultations; determined on a
Annex IX Chapter II Annex XI – Part B If applicable
Annex XI – Part A (Rule 14, Rule 18, Rule 21) case-by-case basis taking into account the nature
Technical Documentation Production Quality Production of the changes proposed.
for every device Assurance Verification
Updated at least annually ‘if indicated’. Notified
Summary of Safety and Clinical
Yes Body to review at the time of PSUR assessments or
Performance (Article 32)
substantial change reviews.

Consultation
2001/83/EC, EC/726/2004, Updated as per manufacturer’s clinical evaluation
2004/23/EC, EU/722/2012 Clinical Evaluation Report updates plan. Notified Body to review at the time of PSUR
reviews or substantial change reviews.

Updated at least annually. Notified Body review at

Post Market Clinical Follow-Up Update Report
Clinical Evaluation (Article 61)
the time of PSUR reviews or substantial change
reviews.
Consultation Procedure
Annex IX Sec. 5 / Annex X Sec. 6
Periodic Safety Update Report Updated at least annually. Submitted to Notified
(Article 86) Body via EUDAMED for Notified Body review.

Unannounced Audits At least once every 5 years.

CE marking
Declaration of conformity * If sterile or re-usable surgical instruments.

(Annex IV) (Annex V) ** The Y3 “Recert” indicated in the table refers to the recertification audit related to EN ISO 13485:2016 certificate cycle which is typically three years. Most
manufacturers with MDR/IVDR certificates also hold EN ISO 13485 certificate.
CE 2797

MDR Conformity Assessment Routes 10

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 Applicable audits, assessments and requirements
Custom-made Class III implantable devices Custom-made Class III implantable devices

Custom-made Initial Surveillance

Class III Conformity
implantable devices Assessment Y1 Y2 Y3 Y4 Y5

Custom-made QMS Audits Yes Yes Yes Recert** Yes Yes

Class III Annex XIII
Documentation Microbiology Audits Yes* N/A N/A Yes* N/A N/A
implantable
devices No stand-alone Technical Documentation assessment. However, relevant
Technical Documentation
parts of Technical Documentation may be audited as part of QMS/
Assessment
Microbiology audits.

Clinical Evaluation Consultation

N/A N/A N/A N/A N/A N/A
Procedure (Article 54)

Consultations
N/A N/A N/A N/A N/A N/A
Annex XI – Part A (Rule 14, Rule 18, Rule 21)
Annex IX QMS
Production Quality
Chapter I
Assurance Summary of Safety and Clinical
N/A N/A N/A N/A N/A N/A
Performance (Article 32)

Clinical Evaluation Report updates N/A N/A N/A N/A N/A

As per manufacturer’s PMS, PMCF plans. Notified

Post Market Clinical Follow-Up Update Report Body QMS audits to verify implementation of
(Article 61) the plan.
Statement
Annex XIII Section 1 Updated at least annually. Not required to be
Periodic Safety Update Report submitted to EUDAMED for Notified Body review.
(Article 86) Notified Body to verify updates at the time of
surveillance QMS audits.

Unannounced Audits At least once every 5 years.

CE Certificate * If sterile or re-usable surgical instruments.

** The Y3 “Recert” indicated in the table refers to the recertification audit related to EN ISO 13485:2016 certificate cycle which is typically three years. Most
issued manufacturers with MDR/IVDR certificates also hold EN ISO 13485 certificate.

CE 2797

MDR Conformity Assessment Routes 11

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 Custom-made devices Class I devices
Excluding custom-made Class III implantable devices Excluding Class Is, Ir, Im devices

Custom-made Custom-made

Annex XIII Annex II and III

Documentation Technical
Documentation

Declaration of conformity
Collect PMS, PMCF (Annex IV)
data as per Part B
of Annex XIV

CE marking
Statement
Annex XIII Section 1 (Annex V)

Note: No Notified Body involvement Note: No Notified Body involvement

except for custom-made Class III
implantable devices

MDR Conformity Assessment Routes 12

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 How BSI supports your CE Excellence
Medical Device launch

Readiness BSI Transfer BSI CE-Exellence Programs are designed to support manufacturers seeking timely and effective market access.
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In the competitive medical device marketplace, We offer a seamless transfer to our services
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MDR Conformity Assessment Routes 13

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