Bsi MD Psur Webinar 210323 en GB

 Periodic Safety Update
Report (PSUR)
March 2023
Richard Holborow/Maddalena Pinsi
Contents of Webinar
• Recap of the PSUR MDR/IVDR Requirements
• Expected Contents of the PSUR (MDCG 2022-21)
• The notified body process of evaluating the PSUR
• The PSUR and updating the SSCP
• Uploading your PSUR and SSCP to BSI

3
Recap of the PSUR

Requirements
(MDR and IVDR)
Copyright © 2022 BSI. All rights reserved

What is the Periodic Safety Update Report (PSUR)?
• Article 86 of the MDR requires manufacturers of Class IIa, IIb, III devices to prepare a PSUR
• Article 81 of the IVDR requires manufacturers of Class C & D devices to prepare a PSUR
• The PSUR is a summary of data coming from the post market surveillance plan activities for a given PSUR
time period.
• The PSUR is a point in time of the device(s) current safety and performance.
• This exercise allows the manufacturer to pull together all the outputs of the PMS activities and ensure
the benefit/risk is still favourable to the device(s) under evaluation.
• The PSUR is an interim activity during and after CE certification.
• Class I devices are required to prepare a PMS report per article 85. The classification under the MDR
and not classification under the MDD is the deciding factor whether a PSUR is required.
• Legacy devices that are placed on the market under MDD/AIMDD after the date of application (26th
May 2021) during the transitional period are required to produce a PSUR based upon the timelines of its 4
classification under MDD/AIMDD.
Class IIa Class IIb Class III
Frequency of PSUR? Must be produced at a minimum Must be produced at a minimum 5
Must be produced at a minimum
(MDR/MDD/AIMDD) once every 2 years for all Class once a year for all Class IIb once a year for all Class III
IIa devices. devices. devices.
Upload to EUDAMED*? Only Class IIa Implantable Only Class IIb Implantable All Class III will have PSUR
(MDR) devices will have PSUR uploaded devices will have PSUR uploaded Uploaded to Eudamed.
to EUDAMED. to EUDAMED
*In the absence of EUDAMED the
PSUR must be sent directly to the
PSUR not publicly visible in PSUR not publicly visible in PSUR not publicly visible in
notified body. (MDCG 2021-1)
EUDAMED EUDAMED. EUDAMED.
Notified Body PSUR
Evaluation? Class IIa non-implantable Class IIb non-implantable All Class III completed annually
completed as part of TF completed as part of TF and PSUR evaluation uploaded
surveillance activities. PSUR surveillance activities. PSUR to EUDAMED.
Evaluation will be reported in Evaluation will be reported in
Clinical Evaluation Assessment Clinical Evaluation Assessment PSUR evaluation report is not
Report (CEAR). Report (CEAR). publicly visible in EUDAMED.
Class IIa implantable devices Class IIb implantable devices

have PSUR evaluation report have PSUR evaluation report
completed every 2 years and completed every year and
uploaded to EUDAMED. uploaded to EUDAMED.
PSUR evaluation report is not This includes Well Established

publicly visible in EUDAMED. technologies (WET) per Article 54
PSUR evaluation report is not

publicly visible in EUDAMED.
Article 86 (MDR)/Article 81 IVDR 6
Article 86(MDR) Article 81 (IVDR):

Throughout the lifetime of the device concerned, that
the conclusions of the
PSUR shall set out: benefit-risk
the main findings of the
PMCF/PMPF;
determination;
(a) the conclusions of the benefit-risk determination;
(b) the main findings of the PMCF/PMPF; and
(c) the volume of sales of the device and an estimate the volume of sales of
the device and an
evaluation of the size and other characteristics of the estimate evaluation of
population using the device and, where practicable, the the size and other
usage frequency of the device. characteristics of the
population using the
device and, where
practicable, the usage
frequency of the device

PSUR is the output of the PMS Plan 7
Article 86 - Class III, IIb, IIa (MDR): Article 84 (MDR)– PMS Plan:
Article 81 - Class C&D (IVDR): Article 79 (IVDR)– PMS Plan:
Manufacturers of class IIa, class IIb and class III

devices/Class C & D shall prepare a periodic safety
update report (‘PSUR’) for each device and where The post-market surveillance system referred to in Article 83
relevant for each category or group of devices (MDR) /Article 78 (IVDR) shall be based on a post-market
summarising the results and conclusions of the surveillance plan, the requirements for which are set out in
analyses of the post-market surveillance data gathered Section 1.1(MDR)/1 (IVDR) of Annex III.
as a result of the post-market surveillance plan For devices other than custom-made devices, the post- market
referred to in Article 84(MDR) Article 79(IVDR) surveillance plan shall be part of the technical documentation
together with a rationale and description of any specified in Annex II.
preventive and corrective actions taken.

What activities should be included in a PMS Plan? 8
Annex III 1.1 (MDR) / Annex III 1. (IVDR)

These are activities listed in
section 1.1 (a) (MDR) and
information from trend
relevant specialist or
technical literature, section 1 (IVDR)
reporting; databases and/or
registers;
— information,
records referring to
including feedbacks
non-serious incidents
and complaints,
and data on any
provided by users,
undesirable side-
distributors and
effects;
importers;
information concerning
serious incidents,
including information
PMS publicly available
Plan
information about
from PSURs, and field
similar medical devices
safety corrective
actions;

Annex III & Article 83 (2) MDR / Article 78 (2) IVDR 9
The technical documentation on post-market surveillance to be drawn up by the

manufacturer in accordance with Articles 83 to 86 (MDR)/Articles 78 to 81 (IVDR)
shall be presented in a clear, organised, readily searchable and unambiguous
manner and shall include in particular the elements described in this Annex.
(Annex III)
PSUR
The post-market surveillance system shall be suited to actively

and systematically gathering, recording and analysing relevant
data on the quality, performance and safety of a device
throughout its entire lifetime, and to drawing the necessary
conclusions and to determining, implementing and monitoring any
preventive and corrective actions. Copyright © 2022 BSI. All rights reserved
Contents of the PSUR (MDR/IVDR*) 10
• Volume of Sales by region over time

• Estimated size of the patient population using the
Annex device over time.
III • Characteristics of the population using the device over
time
Contents • Post-Market Surveillance : Vigilance and CAPA
of the •
information
PSUR
Post-Market Surveillance: information including
general/specific Post-Market Clinical/Performance
Follow-up (PMCF/PMPF) information
Articles
86/81*
*It is expected that the IVDR guidance will follow the same requirements
of MDCG 2022-21
MDD/AIMDD/IVD Device PSUR Vs MDR/IVDR Device PSUR 11
Per MDCG 2021-25 (MDD/AIMDD) The notified body will ensure the
manufacturer through QMS assessments is generating a PSUR.
Per MDCG 2022-8 (IVDD) manufacturer may voluntary choose to develop

DO NOT SUBMIT THE PSUR FOR MDD/AIMDD/IVDD DEVICESPSURs.TO THE NOTIFED BODY UNLESS
SPECIFICALLY REQUESTED.
MDD/AIMDD The notified body will only evaluate the contents of the PSUR for both MDD
/IVD PSUR and IVDD if there are concerns associated with the devices or as part of an
MDR/IVDR application.
Article 86/81 of the MDR/IVDR requires the manufacturer to

generate a PSUR for all class IIa, IIb, III/Class C&D devices.
The notified body will evaluate these PSURs but the process will be
MDR/IVDR based on classification.
PSUR

12
Expected Contents of the

PSUR
(MDCG 2022-21)

MDCG 2022-21 13
• Released December 2022.
• Guidance is intended specially for manufacturers
• No notified body guidance.
• Provides information on
• PSUR Content
• Scope and Duration of PSUR
• Grouping of Devices
• PSUR preparation and issuance
• Templates
• Specific IVDR PSUR guidance to follow. Task force

to be set up in 2023.

Poll Question. 14
Does a manufacturer have to follow the PSUR template

provided in MDCG 2022-21?
- Yes
- No
- It Depends

Poll Question. 15
Does a manufacturer have to follow the PSUR template

provided in MDCG 2022-21?
- Yes (Please!)
- No
- It Depends

Lets remember the wording in Annex III… 16
The technical documentation on post-market surveillance to be drawn up by the manufacturer in accordance with Articles
83 to 86 (MDR)/Articles 78 to 81 (IVDR) shall be presented in a clear, organised, readily searchable and unambiguous
manner and shall include in particular the elements described in this Annex. (Annex III)
• It is essential manufacturers follow the template/format developed in MDCG 2022-21.

• Ensure that all section titles are presented in the PSUR, and when these sections are not
applicable please provide a justification.
• Failure to follow the template and provide the information requested in the PSUR will result in
the PSUR being rejected for evaluation and your certificate may be at risk.
• It is critical that you adequately explain in detail within the PSUR any anomalies along with any
actions you may be taking to address these concerns.
It is essential that both notified bodies and manufacturers ensure that the PSUR is an efficient
process that allows resource to be used for MDR applications .

This is the minimum expected contents of a PSUR based on MDCG 2022-21 17
• Grouping Rationale
• Volume of Sales by region over time
• Estimated size of the patient population using the device over time.
• Characteristics of the population using the device over time
• Post-Market Surveillance : Vigilance and CAPA information
• Post-Market Surveillance: information including general Post-Market
Clinical/Performance Follow-up (PMCF) information
• Summary of Findings and conclusions
• Actions taken by the manufacturer (If any -this may include updates
to SSCP/SSP)
MDCG 2022-21 suggests for any absence of this

information a justification should be provided.

18
 Grouping of Devices
Considerations for Grouping of Devices in PSUR

Grouping of Devices – 1 Basic UDI 19
1 Basic UDI = Common Intended Purpose covering

One Basic-UDI
all sizes and variants
The devices should be linked by a Common Intended Purpose or

Multiple Basic-UDI commonality in design. This should be justified within the PSUR for
grouping.

What is not considered appropriate grouping? 20
Higher risk devices that do not offer

a common intended purpose
Devices with different technology

design or completely unrelated
The notified body is always required to demonstrate appropriate technical and clinical expertise are applied to the
device under evaluation. Therefore from a practical perspective it is not feasible to include devices in a PSUR that
have an unrelated common intended purpose or are a different design technology as this will require multiple
reviewers to evaluate a single PSUR which will not allow us to meet the required timelines. Copyright © 2022 BSI. All rights reserved
Grouping Devices – Leading Device 21
• When multiple Basic –UDI are incorporated into the PSUR a

leading device needs to be chosen to drive the timepoints for
producing the PSUR.
Oct 2022
• The Leading Device should be the highest risk Classification
or the ‘main therapeutic/diagnostic device’.
• For variants of the same classification in this example the

first timepoint of the device placed on the certificate should
be the leading device to ensure that the PSUR reporting time
Leading Device
periods are met.
Nov 2022 Nov 2022 Dec 2022
Device #2 Device #3 Device #4

Grouping Devices – Leading Device 22
• When multiple Basic –UDI are incorporated into the

PSUR a Leading Device needs to be chosen
• The Leading Device Should Be The Highest Risk

Classification or the ‘main device’
• In this example the pacemaker is the leading device

Leading Device and the accessories although Class III are not the
‘main device’
Grouping accessories with the main

device in the PSUR is an appropriate
method to reflect the safety and
performance of the overall system.
Accessory Accessory
Accessory
23
 Sales/Usage Information
Considerations for Sales/Usage Information

Sales/Usage Information 24
Volume of sales could be: • The method used should be • Volume of Sales should
consistent throughout the distinguish between:
• Actual Sales PSUR when evaluating
• Units Shipped PMS data. • Model numbers (UDI)
• Units Implanted • Sizes
• Or another Suitable Method • Data should be presented • Variants
on a year-by-year
• Approximate numbers is not comparison irrespective of
appropriate classification. This allows for
a comparative assessment
to be made. Copyright © 2022 BSI. All rights reserved
Usage Information 25
• Method of use should be justified and be acceptable.
Reusable Devices may Larger Lower Volume

choose to report against the devices may choose to
number of uses based on a justify against usage and
justified calculation active installed base

Geographical regions 26
Volume of Sales – Expectation that EU Data is presented

separately to Worldwide Data.
EU Sales Data – Should include EEA + TR + XI
EEA European Economic Area

TR Turkey
XI Northern Ireland
Worldwide data also includes sales of EU.

Example Table within Guidance MDCG 2022-21 27
Basic UDI-DI/ Legacy device name or model

Number of Total Devices
Total Number Reporting N – 12 N2-12 N3-12 ever sold.
of devices Day+ months months (N3) months
preceding 12 (N2) (N4)
months (N)
Data Split.
EEA+TR +
Worldwide data should
XI
also include EU Data.
Worldwide
4 Year Data Presented Split ‘Year by Year’.

There is no legal requirement to include data before 26th May 2021 but reference to previous
historical data can support the evaluation. Copyright © 2022 BSI. All rights reserved
28
 Characteristics of the
Population Using the Device
Considerations for Characteristics of the population using
the device.

Discussion Points from Working Group… 29
‘Is the device being used as intended purpose?’
‘Is there any off-label use of the device?’
‘What are the sexes, ages, ethnic profiles of the

individuals mainly using the device?’
‘This information could help a manufacturer to

determine that their intended purpose or indication
needs further consideration’
‘Population could be users not necessarily patients’

Collection of population data… 30
Certain devices may lend themselves to being able to collect

patient population data from registries such as implantable
devices or devices undergoing specific PMCF activities.
Other devices not be for a specific population and may not hold
such detailed information about the use of the device. It is
accepted in these circumstances that a justification may be
acceptable.

Considerations for Characteristics of population using the device 31
• Manufacturer may identify
• The % or number of cases where the device has been used

‘on-label’
• The profile of patients or users exposed to the device
• Most used patient group e.g. 95% use in over 65 females
• Least common patient groups e.g. 3% of paediatric populations
• Detailed information may be tabulated based on gender, age

and indication
• Note: This is a specific MDR requirement so a justification

should always be provided if no data is presented.

32
 Vigilance Data
Considerations for Vigilance Data

PSUR & Vigilance 33
Expectation:
• Individual detailed vigilance reports are not to
be provided within the PSUR although absolute
reporting rates should be reported against EU
& Worldwide Sales.
• Summary of reported vigilance should be
provided indicating
• Most reported vigilance episodes
• Justification of levels of reported vigilance
• Commonly frequent occurring Medical Device Problem
(Annex A IMDRF)
• Common Investigation Findings (Annex C IMDRF)
• Health Impacts (Annex F IMDRF)
• Investigation Conclusion (Annex D IMDRF)

What should I be making clear in the PSUR in relation to Vigilance? 34
New Identified Risks Trending or Emerging Risks
New risk identified that is

A significant trend of a
not listed within the
specific serious event over
technical documentation of
time
the device.
What actions are you taking to address the vigilance issues?

36
 Preventive & Corrective

Actions
Considerations for Preventive and Corrective Actions

Article 83 (4) Article 78 (4) & CAPAs 37
When in the course of the post-market surveillance, a need for Corrective Actions or Preventive Actions (CAPAs)
as defined in Article 83(4) first sentence is identified, the manufacturer should implement the appropriate
measures and inform the Competent Authorities concerned and, when applicable, the Notified Body.
MDCG 2022-21
Article 83 (4)(MDR) Article 78 (4) (IVDR):
If, in the course of the post-market surveillance, a need for preventive or corrective action or both is identified, the
manufacturer shall implement the appropriate measures and inform the competent authorities concerned and, where
applicable, the notified body. Where a serious incident is identified or a field safety corrective action is implemented, it
shall be reported in accordance with Article 87/Article 82.

Reporting of CAPAs in the PSUR CAPAs under Article 83(4) are not limited to safety issues
38
however it does not cover quality management system

related CAPA’s unless these could have a direct impact on
product safety, performance or quality.
• Devices already placed on the EU market.

• Issues that might have a direct impact on product and that
might impact product safety, performance or quality and,
• Evaluation of benefits and risks identified through post-market
activities as described in Annex III, point 1.1 (a) of MDR.
A summary of all the above Article 83(4) CAPAs can be made available on request to the Competent
Authorities either through the PSUR or through a specific report. However, all safety related CAPAs should
be part of the PSUR (see section 2.2). (MDCG 2022-21)

39
 PMCF (Specific & General)
Considerations for PMCF (Specific & General)

Main Findings of PMCF/PMPF – Article 86(MDR) /81 (IVDR) 40
The PSUR is a ‘standalone

Throughout the lifetime of the device concerned, that PSUR shall set out:
report’
(a) the conclusions of the benefit-risk determination;
It is expected the main
conclusions of the PMCF
(b) the main findings of the PMCF/PMPF; and
are presented within the
PSUR
(a) the volume of sales of the device and an estimate evaluation of the size and other
characteristics of the population using the device and, where practicable, the usage
frequency of the device.

General Vs Specific PMCF/PMPF Activities. 41
General PMCF/PMPF Specific PMCF/PMPF
✓ Clinical Experience Gained ✓ Evaluation of Suitable Registers

✓ Feedback from Users ✓ PMCF/PMPF Studies
✓ Screening of Literature
✓ Screening of ‘other sources’ Annex XIV Part B (6.2 (a) ) (MDR)
Annex XIII Part B (5.2 (b) )(IVDR)
Annex XIV Part B (6.2 (a) ) (MDR)
Annex XIII Part B (5.2 (a) )(IVDR)

What is considered a ‘main finding’ ? (Not Exhaustive) 42
❑ Conclusions of a completed Specific PMCF/PMPF Activity
❑ Identification of new risk from General/Specific PMCF/PMPF

Activities
❑ Identification of usability concerns from PMCF /PMPF Activities
❑ Identification of under performance from PMCF /PMPF Activities
❑ PMCF/PMPF Enrolment Concerns
❑ Identification of Systematic Mis-use or Off-Label Use.
❑ Deviation of PMCF /PMPF Protocol

Purpose/Aim of PMCF 43
The PMCF/PMPF plan shall specify the methods and procedures for proactively collecting and evaluating clinical data with
the aim of:
(a) confirming the safety and performance of the device throughout its expected lifetime,
(b) identifying previously unknown side-effects and monitoring the identified side-effects and contraindications,
(c) identifying and analysing emergent risks on the basis of factual evidence,
(d) ensuring the continued acceptability of the benefit-risk ratio referred to in Sections 1 and 9 of Annex I, and (e)(MDR)
/Sections 1 and 8 of Chapter I of Annex I,(IVDR)
(e) identifying possible systematic misuse or off-label use of the device, with a view to verifying that the intended
purpose is correct. Annex XIV Part B 6.1 (MDR)
Annex XIII Part B 5.2 (IVDR)

Updates on PMCF Activity 44
- The PSUR serves as an opportunity to

ensure manufacturers are committing to their
PMCF obligations
- There should be some information on the

progress of the PMCF Activity mentioned
within the PSUR
- Subject Enrolment
- Site Enrolment
- Timepoints of Data Collection
- Adherence to PMCF Protocol

45
 Overall Conclusions
Considerations for Overall Conclusions

Overall conclusions from the analysis of the collected data 46
The manufacturer should outline any new or emerging risks identified or when common occurrences of poor
performance or claimed benefits have not been achieved within the current reporting period. When there are
new or emerging risks that have been identified, the manufacturer should consider any specific patient groups,
device models, accessories used, geographical regions impacted, duration of risk etc. Specific information
should be provided on the seriousness and the full potential clinical impact of these risks.
o The manufacturer may also describe any new benefits that have been identified from the
reporting period.
o The manufacturer should formulate evidence-based conclusions to determine whether the
benefit-risk profile of the device has changed.
o Finally, within the conclusion, the manufacturer should declare whether there has been an
adverse impact on the benefit-risk profile of the device.

Actions taken by the manufacturer 47
o The manufacturer should describe any specific actions that have been taken to address
any newly identified or emerging risks and occurrences of poor performance.
o The manufacturer should identify all actions initiated during the data collection period
as described in Article 83 (3) (MDR)/ Article 78 (3) (IVDR) .
Please ensure you describe fully any actions you are taking in
relation to any concerns identified within your PSUR.
Failure to adequately describe the actions being taken may result

in a technical documentation assessment to review the safety and
performance of the device under evaluation.

48
PSUR and updating the

SSCP

Poll Question. 49
Can I submit SSCP changes with my PSUR that are

outside of the contents of the PSUR?
- Yes
- No
- It Depends!

Poll Question. 50
Can I submit SSCP changes with my PSUR that are

outside of the contents of the PSUR?
- Yes
- No
- It Depends!

PSUR Evaluation and Updating the SSCP 51
SSCP updates at time of SSCP updates that go beyond the content of

PSUR evaluation must be the PSUR will require other technical
limited to the content of the documentation to be submitted (e.g. CER) and
PSUR. this then is not a PSUR evaluation but rather
a technical documentation assessment.
This will require a change notification request

for the validation of these SSCPs to be
conducted outside of the PSUR evaluation or
when possible they may be completed at
SSCP another conformity assessment timepoint e.g.
PSUR Renewal.
Administrative updates to the SSCP

may be submitted at time of PSUR
evaluation.
Please think carefully before updating your SSCP! 52
Article 61 (11)
For class III devices and implantable devices, the PMCF evaluation report and, if indicated, the summary of safety and
clinical performance referred to in Article 32 shall be updated at least annually with such data.
• Remember the purpose of the SSCP – To inform the Health Care Professional (and Patient) of the
safety and clinical performance data held on the device.
• If new data suggests there is no change to the safety profile of the device or there is no impact to
the performance of the device, then an update may not necessarily be required as the information
within the SSCP still remains valid.

Updating the SSCP 53
Not every update to an SSCP is Ensure your SOP is clear on

required to be validated. You can what is a significant and non-
still perform non-significant significant update.
updates to the SSCP and wait
until the next timepoint such as a The SOP should be clear when
renewal of your certificate to significant updates are required
validate these updates. to be sent to the notified body.
e.g. additional clinical data that

does not offer any new insights
to safety or performance
SSCP

When should the SSCP be updated and validated outside of a design change or 54
renewal?
Examples of significant updates that should be Examples of non-significant updates that could
validated as part of PSUR evaluation. be deferred to next conformity assessment for
validation – e.g. Renewal, Design Change.
1. New Risk Identified. 1. New Clinical Data that does not impact the safety
or performance of the device e.g. Outputs of literature
data that does not impact the safety or performance
of the device
2. Negative Change in Performance 2. Update and clarification on the text
3. Emerging Trends/Increase in Risk. 3. Changes in risk that are lower than those reported
in the validated SSCP
If the benefit/risk profile of the device remains unchanged then what advantage is validating the
SSCP at the PSUR evaluation timepoint?
Remember the purpose of the SSCP – To inform the Health Care Professional (and Patient) of the
safety and clinical performance data held on the device.

55
The notified body process of

evaluating the PSUR

Will I receive a copy of the PSUR evaluation report? 56
As these devices require a specific PSUR evaluation report to be uploaded

into EUDAMED and the notified body are required to evaluate every PSUR at
the appropriate frequency.
The notified body is required to provide a copy of the PSUR evaluation report
Class III, to the manufacturer. In the absence of EUDAMED this will be sent at the end
Implantable of the evaluation.
and Class D
For these devices PSURs will be evaluated as part of technical file sampling
plans. As these PSUR evaluations do not need to be uploaded into Eudamed
a separate evaluation report is not required.
Class IIa/IIb
Non-
The manufacturer will receive the CEAR/PEAR - This will contain the
Implantable
and Class C information on the PSUR.

Right First Time. – Class III and Implantable Devices 57
Failure to submit a PSUR within 90 days or a PSUR that provides

insufficient information not aligned to MDCG 2022-21 will result in a
90 Days* reminder request being sent by the notified body and a further 30
days to submit the PSUR. Failure to comply with result in the
PSUR certificate being suspended and eventually cancelled.
PSUR is
generated after
required
timepoint of data
collection
*These are timelines identified within the EUDAMED Playground

What happens if there are issues with my PSUR? (Class III and Implantable) 58
If the notified body can agree through the contents of the

PSUR that the benefit/risk is not adversely impacted however,
improvements could be made then the notified body will
PSUR provide general feedback in the PSUR Evaluation that must
be considered as part of your next PSUR Submission.
If the notified body does not agree through the contents of the
PSUR that the benefit/risk is not adversely impacted then the
PSUR evaluation concludes and a technical documentation
assessment shall begin to specifically additional
PSUR documentation and evaluate more widely the benefit/risk
assessment.

Next Steps 59
12 months
PSUR PSUR
To ensure efficiency in the PSUR evaluation process, and to ensure BSI can focus on MDR
application work, BSI is unlikely to allow rounds of questions during the PSUR Evaluation so it is
critical that you ensure that your PSUR is compliant to the template provided in MDCG 2022-21 and
contains adequate explanations for the data within the PSUR to avoid unnecessary technical
documentation assessments.
A client communication will follow in the coming weeks to confirm the evaluation process.

60
BSI Electronic Client

Portal and PSUR/SS(C)P

 Portal tabs 61
Vigilance Incident Technical Document Technical Support

Reporting Upload
• MIR • Initial submission To report your issues or any
• FSCA • Response to BSI reviewer technical difficulty
• SS(C)P & PSUR Document
• Other

 Accessing the portal 62
The BSI Electronic Client Portal

database can be accessed via
the following link:
https://medtech.bsigroup.com
Enter your username and

password to access the site.
If you do not already have a

username and a password,
register for a new account.

 Setting up your account 63
Large organisation Alternative name and NOTE

with multiple users contact
• Create one generic/ Required to ensures that Access is provided to the

common account for BSI can always contact whole portal (i.e., both
your staff to access someone if the main Vigilance Incident
• Request our Technical account holder is Reporting and Technical
Support Team to create a unavailable Document Upload), not to a
group account specific area

 Uploading SS(C)P/PSUR 64

Add new
Enter your certificate number,

selecting the correct prefix
Certificate prefix
• MDR/IVDR for Regulations
What certificate to enter
Devices covered by a product

certificate and a quality based
one: enter the Product Certificate
only

Download guidance on
document upload, if needed
Important!
Enter the correct certificate

number, since the portal will send
an automatic notification to the
XXXXXX Scheme Manager’s name
Scheme Manager once you have
uploaded your documents

Purpose of submission
SS(C)P & PSUR Document
Use when sending SS(C)P

and/or PSUR documents.
• PSUR
• Unvalidated SS(C)P
• Translated SS(C)P
DO NOT submit translations of

SS(C)P documents until BSI
sends notification that uploads
are starting to EUDAMED

Enter the Basic UDI-DI

Add multiple certificates,

if applicable (max 15)
Multiple certificates XXXXXX Scheme Manager’s name
Only if the document uploaded

is common to all the certificates
and Basic UDI-DIs entered

Certificate n.1
XXXXXX
XXXXXX
Certificate n.2

Add document(s)

Select document type

73
Uploading SS(C)P

 Uploading SS(C)P 74
A Upload document

A Upload document
Invalid file type
Valid file type
Max upload size
The maximum individual file

upload size is 500mb

B Select the “Submission Type”
Pre-certification
English language or non- B

English language SS(C)P before
the certificate is issued
Post-certification
English language or non-

English language SS(C)P after
the certificate is issued

Provide information:
C • Manufacturer Name
• Manufacturer’s SRN number
• EU Representative, if applicable

D Provide information on Master

(English) SS(C)P:
• Reference number
• Revision number
• Document date issued
Reference number
Same reference for the English

version (the master version)
and other language
translations
Example
D
3 SS(C)P documents (1 in
English version, 1 in Italian and
1 in Spanish): all 3 documents
will have the same reference
number


(English) SS(C)P:
• Revision number
Revision number
Same revision number for the

English version (the master
version) and other language
translations
Example
D
3 SS(C)P documents (1 in
English version, 1 in Italian and
1 in Spanish): all 3 documents
will have the same revision
number


(English) SS(C)P:
• Revision number
Document date issued
Date when the English version

of the SS(C)P (the master D
version) has been issued

E Select the SS(C)P document

language
SS(C)P document language
DO NOT submit translations of

SS(C)P documents until BSI
sends notification that uploads
are starting to EUDAMED
F Save
E

G Submit
Scheme Manager notified
Automatic notification to your

Scheme Manager
G

83
Uploading PSUR

 Uploading PSUR 84
A Upload document A

Provide information:
B • Manufacturer Name
• Manufacturer’s SRN number
• EU Representative, if applicable

C Provide information on
Manufacturer’s PSUR:
• Revision number
• If it covers class D/III or
implantable devices
D Save
C

E Submit
Scheme Manager notified
Automatic notification to your

Scheme Manager E
E

 “Uploaded documents” dashboard 88
“Uploaded documents” tab
Record of documents uploaded from your

account

 Uploading SS(C)P and PSUR at the same time 89
One submission
You can submit PSUR and SS(C)P

documents at the same time, against
the same Certificate(s) and Basic
UDI-DI(s)
Single submission can include both

PSUR and SS(C)P, selecting both the
documents via “Add Documents”
XXXXXX XXXXXX XXXXXX XXXXXX XXXXXX
XXXXXX XXXXXX XXXXXX XXXXXX

 Revised PSUR and/or SS(C)P 90
If, during our evaluation process of

your PSUR and/or SSCP, you wish to
submit any updated revisions, please
DO NOT submit through the portal.
Contact your Scheme Manager as we
will need to confirm if the review has
commenced and whether it is still
possible to submit any updates at the
point of the assessment.

One Slide Reminder 91
• Do NOT send MDD/AIMDD/IVDD PSURs for to BSI unless specifically

requested.
• Please follow the template/minimum content provided in MDCG 2022-21

when producing your PSUR.
• Ensure you adequately explain all actions taken to address any anomalies
within the PSUR.
• Only submit an SSCP for validation with your PSUR if the contents of the
SSCP need updating based on the data from the PSUR.
• If you wish to resubmit an SSCP/PSUR during an evaluation please

speak with your scheme manager first before submitting as we will
need to check the stage of the review.

92
Questions…

93
 End slide

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 Periodic Safety Update

• Recap of the PSUR MDR/IVDR Requirements

• Expected Contents of the PSUR (MDCG 2022-21)

• The notified body process of evaluating the PSUR

• The PSUR and updating the SSCP

• Uploading your PSUR and SSCP to BSI

Recap of the PSUR

Copyright © 2022 BSI. All rights reserved

• The PSUR is an interim activity during and after CE certification.

Class IIa implantable devices Class IIb implantable devices

PSUR evaluation report is not This includes Well Established

PSUR evaluation report is not

Article 86(MDR) Article 81 (IVDR):

Copyright © 2022 BSI. All rights reserved

Manufacturers of class IIa, class IIb and class III

Copyright © 2022 BSI. All rights reserved

Annex III 1.1 (MDR) / Annex III 1. (IVDR)

Copyright © 2022 BSI. All rights reserved

The technical documentation on post-market surveillance to be drawn up by the

The post-market surveillance system shall be suited to actively

• Volume of Sales by region over time

Per MDCG 2022-8 (IVDD) manufacturer may voluntary choose to develop

Article 86/81 of the MDR/IVDR requires the manufacturer to

Copyright © 2022 BSI. All rights reserved

Expected Contents of the

Copyright © 2022 BSI. All rights reserved

• Released December 2022.

• Guidance is intended specially for manufacturers

• No notified body guidance.

• Specific IVDR PSUR guidance to follow. Task force

Copyright © 2022 BSI. All rights reserved

Does a manufacturer have to follow the PSUR template

Copyright © 2022 BSI. All rights reserved

Does a manufacturer have to follow the PSUR template

Copyright © 2022 BSI. All rights reserved

• It is essential manufacturers follow the template/format developed in MDCG 2022-21.

Copyright © 2022 BSI. All rights reserved

MDCG 2022-21 suggests for any absence of this

Copyright © 2022 BSI. All rights reserved

Considerations for Grouping of Devices in PSUR

Copyright © 2022 BSI. All rights reserved

1 Basic UDI = Common Intended Purpose covering

The devices should be linked by a Common Intended Purpose or

Copyright © 2022 BSI. All rights reserved

Higher risk devices that do not offer

Devices with different technology

• When multiple Basic –UDI are incorporated into the PSUR a

• For variants of the same classification in this example the

Nov 2022 Nov 2022 Dec 2022

Device #2 Device #3 Device #4

Copyright © 2022 BSI. All rights reserved

• When multiple Basic –UDI are incorporated into the

• The Leading Device Should Be The Highest Risk

• In this example the pacemaker is the leading device

Grouping accessories with the main

Considerations for Sales/Usage Information

Copyright © 2022 BSI. All rights reserved

• Method of use should be justified and be acceptable.

Reusable Devices may Larger Lower Volume