March 2023

WHITEPAPER

PERIODIC SAFETY
UPDATE REPORT (PSUR):
A BREAKDOWN OF MDCG 2022-21

©Cactus Life Sciences Inc. All rights reserved.

All registered trademarks are property of their respective owners.
 Table of Contents

1 Does my device require a PSUR? 01

2 When do I need to start planning my PSUR? 04

3 What are the contents of a PSUR and where can I find the information? 07

4 How do I submit a PSUR? 09

5 Conclusion 09

6 Key recommendations from Cactus Life Sciences 10

 Introduction

In December 2022, the Medical Device Coordination Group (MDCG) released the much-awaited
guidance on the periodic safety update report (PSUR), with the main objective of assisting manufacturers
in implementing the legal requirements laid down in Article 86 of the European Union (EU) 2017/745
Medical Devices Regulation (MDR) on PSURs. A PSUR is a summary of the results and conclusions of the
analysis of post-market surveillance (PMS) data. The guidance document lays out the objectives for a
PSUR, which include identifying and evaluating the changes to the benefit-risk profile and summarizing
the initiation and implementation of corrective actions and preventive actions (CAPAs), as needed,
during PMS activities.

The aim of this whitepaper is to help manufacturers of medical devices implement the recommendations
stated in the guidance document and Article 86 of the EU MDR. This whitepaper simplifies the guidance
by highlighting the possible inferences for strategic planning, so that the requirements can be
implemented accurately for a seamless PSUR creation experience.

Details on key elements that determine the applicability of a PSUR, points to be considered while
planning the timeline, contents required for creation of a PSUR with tips on how to leverage the
information to other documents, and the PSUR submission pathway are summarized below.

Does my device require a PSUR?

The key element that determines whether your device requires a PSUR is device
classification. As depicted in Figure 1 below, Class IIa, IIb, and III devices require a
PSUR. For a Class I device (including Class Ir, Is, and Im devices and class
self-certified devices), a PMS report needs to be generated to capture the
information about PMS activities (per Article 85 of the EU MDR and MDCG
2022-21).

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 Device classes Device classes NOT
REQUIRING a PSUR REQUIRING a PSUR

Class I SC
Class III
Class Ir
Class IIb
Class Is
Class IIa
Class Im

Figure 1: The device classes that require a periodic safety update report (PSUR)

Now that we have identified the devices requiring a PSUR, have you planned which devices will be grouped
together in your PSUR? This will require strategic planning ahead of time, so that all documents in the
technical documentation can be aligned.

Basically, notified bodies expect to review PSURs based on the device classification and grouped by the
sampling rules defined in MDCG 2019-131 :
• Devices with same Basic Unique Device Identification-Device Identifiers (UDI-DIs) for Class III devices
• Devices with the same 4th level of European Medical Device Nomenclature (EMDN code for
Class IIb devices)
• Devices with the same MDN/MDA code for Class IIa devices

However, MDCG 2022-21 now emphasizes that multiple devices of different device classifications can be
grouped in a single PSUR provided a suitable justification is drafted to support the grouping of devices.
Of note, a PSUR needs to cover devices that are certified by a single notified body.
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Guidance on sampling of devices for the assessment of the technical documentation

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 The French Competent Authority, ANSM, mentioned during a webinar held on December 13th, 2022,
that grouping of devices may be done based on any of the following options:

Principles of Devices used together for Other relevant

equivalence a common intended justifications after
described in purpose. E.g., system as consultation and
described in Article 22 of
Annex XIV of agreement with
the MDR, with devices
the MDR the notified body
intended to be used
together to achieve the
intended medical purpose

With multiple devices grouped together, a “leading device” (“with highest risk class or one of the highest risk
classes” per MDCG 2022-21) needs to be assigned for a PSUR. The nature and classification of this leading
device will determine the requirements (period covered for the collection of data, frequency of update,
submission in the European database on medical devices [EUDAMED] when applicable, etc.) that need to be
fulfilled by the PSUR. The other devices mentioned in a PSUR also need to follow the requirements
applicable for the leading device, irrespective of their device classification or certification date. The same
leading device cannot be selected in different PSURs. However, a leading device can be included into other
PSURs as a non-leading device. It is to be noted that it is possible to add or remove the other devices in
scope of a PSUR, except for the leading device. The PSUR reference number is assigned based on the
“leading device” and will remain the same for future PSUR updates. If any changes are made to the “leading
device” (e.g., new device model, change of Basic UDI-DI, etc.), a new PSUR needs to be created.

Therefore, it is important to plan the scope of a PSUR well in advance,

so that PMS data for all applicable devices can be streamlined.

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When do I need to start planning my PSUR?
The planning for PSUR preparation and submission needs to be started keeping
in mind the MDR transition status of devices, the time required for creating a
PSUR after the data collection period of 12 or 24 months depending on the
device classification, and the end of the PSUR requirement.

The guidance divides the devices that require a PSUR into two categories based on the MDR
transition status – MDR compliant and legacy devices. The MDR compliant devices are the ones that
are certified according to MDR. Legacy devices are the ones that are compliant to Medical Devices
Directive (MDD) 93/42/EEC or Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC
and placed on the European market after the MDR Date of Application (DoA; i.e., 26 May 2021) with
some restrictions, including the need to adhere to the PMS requirements listed in EU MDR (Article
120 of the EU MDR).

The data collection period of the first PSUR starts at the MDR certification date and MDR DoA for the
MDR compliant devices and legacy devices, respectively. Additionally, for the first PSUR, the guidance
provides a provision to deviate from the rules set for the data collection period. The data collection
period of the first PSUR can be different from the frequency of update specified in the regulation (e.g.,
less than 12 months for a Class III device). This provision may help align the data collection period for
the post-market clinical follow-up (PMCF) evaluation report, so that all relevant data can be leveraged
across the document. This provision will also help the manufacturers to update the clinical evaluation
report (CER) and summary of safety and clinical performance (SSCP) before the deadline described in
the MDR (i.e., every year for Class III and implantable devices) and/or specified in the original CER.

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 For that purpose, Cactus Life Sciences recommends establishing the data collection period in the first PMCF
evaluation report and PSUR finishing 12 months or 24 months (depending on the classification) after the end
date of the collection period of clinical data in the last CER (e.g., in the literature search report). Figure 2
depicts the recommended data collection period for the first PSUR to meet the CER/PSUR time constraints
described in the MDR with Class III devices.

Update of CER
MDR PMCF Issuance of (Every year for
CER
CER compliance /PSUR the PMCF Issuance of Class III / as
collection PSUR
issuance date or collection Evaluation defined in the
period MDR DoA period Report last CER for
other classes)

Less than 1 year

Recommendation: 1 year for Class III

1 year later for Class III

Figure 2: Recommended PSUR data collection period for Class III devices

The end of the data collection period for one PSUR marks the start date of the data collection period for the
next PSUR. Considering PMS, PMCF, CER, and SSCP (if applicable) are completely connected and shall have
their contents aligned, we recommend defining a single data collection period for all these activities that shall
be contiguous over the following years.

The guidance also allows analysis of the first PSUR to be based on the historic PMS data that are collected
prior to the MDR DoA or MDR compliance dates. The historic data can be presented in a different format
than the MDR PSURs (e.g., summary format).

The PSUR document needs to be updated until the end of device lifetime as defined in the technical
documentation (e.g., PSURs for an implantable device with 5 years of shelf-life and 10 years of lifetime need
to be created for 15 years after the last product is placed on the market). This is also applicable to a legacy
device for which the PSUR needs to be created after the MDR transition period until the end of device
lifetime (defined in the technical documentation). The PSURs will be required even after the EC/EU
certificates have expired or the devices are no longer commercialized under a valid EC/EU certificate.

Therefore, planning the timeline and strategy for creating a PSUR well in advance will help in streamlining the
data collection period and help to ensure alignment across documents. The frequency for future updates
needs to be planned in contiguous sequence per the requirements stated in the guidance document.

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Connection between post-market activities
Figure 3 below justifies the lifecycle of MDR deliverables and how their timelines are inter-related based on
MDR and MDCG 2022-21.

As shown in Figure 3, the reports (i.e., the PMCF evaluation report, PSUR, CER, and SSCP) need to be created
per the strategy set up in plans (i.e., the CEP, PMCF plan, and PMS plan). The contents can be leveraged across
the documents, namely the literature search results of the device under evaluation and similar devices from the
PMCF evaluation report shall be leveraged to the PSUR, CER, and SSCP, as applicable; the PMS data and
benefit-risk discussion from the PSUR shall be leveraged to the CER; all applicable contents from the CER can
be leveraged to the SSCP; and so on. Figure 3 also shows the submission frequency of each deliverable, which
needs to be taken into consideration while planning the timelines.

Every year Every year Start of post-market cycle

Article 61 Article 61

CER Update SSCP Update CEP Update

C
Every year for Class
III and implantable
devices Lifecycle
Every two years for
PSUR of MDR PMCF Plan
Class IIa and Class deliverables
IIb non-implantable
devices
B A

PMCF
Evaluation PMS Plan
Report

Every year for Class III

and implantable devices
Article 61

Figure 3: Lifecycle of post-market and clinical documentation

A = Annex III (1.1b): The post-market surveillance plan shall cover at least: [...] a PMCF plan
B = Article 86: PSUR shall set out the main findings of the PMCF
C = Article 61(11): The clinical evaluation shall be updated [...] with clinical data obtained from the implementation of the manufacturer’s PMS plan
D = Article 61(11): The clinical evaluation shall be updated [...] with clinical data obtained from the implementation of the manufacturer’s PMCF plan
D = Frequency of update

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What are the contents of a PSUR and where can
I find the information?
Table 1 below presents the contents that need to be captured in a PSUR (as mentioned in
the guidance document) and provides recommendations from Cactus Life Sciences on
the sources/inputs that can be used for creating PSURs. It also highlights the areas where
contents from a PSUR can be leveraged to other deliverables, as relevant, to build
efficiencies within the team. This will also help in planning multiple deliverables with
overlapping timelines (as discussed in the above section).
As shown in Table 1 below, the MDCG guidance mentions very specific information that is required in
a PSUR. A well-structured, clear, and concise PSUR will enable a seamless notified body review.

Table 1: PSUR data sources and outcomes

Information can be
Outline of a PSUR Contents of a PSUR Source/Input
leveraged to/Output
(Per MDCG guidance) (Recommendations from Cactus Life Sciences)

Cover page • Manufacturer information • Technical documentation

• Medical device(s) covered by • Quality management
the PSUR system
• Notified body name and
organization number
• PSUR reference number
• Version number of the PSUR
• The data collection period
covered by the PSUR
• Table of contents

Executive summary • Brief overview of the PSUR • CER

content • SSCP (if applicable)
• Benefit-risk determination

Description of the • Device classification • Technical documentation • CER

devices covered by • Regulatory date(s) - first • Quality management • SSCP (if applicable)
the PSUR and their declaration of conformity; system
first EC/EU Certificate • Instructions for use
intended uses issued; first date when the
device was CE-marked;
first placed on the market;
first put into service; if
software, date first made
available
• Status of device(s)
• Intended purpose

Grouping of the • Justification for grouping • Technical documentation • CER

devices of devices (or any change • Quality management • SSCP (if applicable)
in previous grouping) system
• Assigning “leading device” • Previous PSURs (if existing)
• PSUR reference number

Volume of sales* • Volumes of sales, units • PMS raw data (sales) • CER
shipped, or units implanted
or another suitable indicator

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 Information can be
Outline of a PSUR Contents of a PSUR Source/Input
leveraged to/Output
(Per MDCG guidance) (Recommendations from Cactus Life Sciences)

Size and other • Details of patients exposed • PMS raw data (including • CER
characteristics of to the device patient population • Risk management
the population • Characteristics of patient characteristics, for e.g., process
using the device groups exposed to the device data stratified by medical • Product labeling,
• Patient demographics, as condition) if applicable
applicable • Clinical literature
• Change in findings, as • Previous PSURs (if existing)
compared to previous PSURs

Post-market • Information concerning • Complaint/vigilance • CER

surveillance†: Serious Incidents‡ raw data • Risk management
Vigilance and • Information from Trend • FSCA data process
CAPA information Reporting (non-serious • Quality management
incidents and expected system (e.g., CAPA data)
undesirable side effects)
• Information from field safety
corrective actions (FSCA)
• Preventive actions and / or
corrective actions (CAPA)

Post-market • Feedbacks and complaints • PMS and PMCF plans • CER

surveillance: from users, distributors, and • PMCF evaluation report • SSCP (if applicable)
General PMCF importers
information • Scientific literature review of
relevant specialist or technical
literature
• Public databases and / or
registry data
• Publicly available information
about similar medical devices
• Other data sources

Specific PMCF • Summary of findings from all • PMCF evaluation report • CER
information PMCF activities (including
PMCF investigations, specific
registries, user or patient
surveys, etc.)

Summary of • Validity of the collected • CER

findings and data by considering any • Risk management
conclusions of deficiencies or bias process
the PSUR • Overall conclusions from • SSCP (if applicable)
the analysis of the collected
data i.e., evaluate the
benefit-risk profile
• Actions taken by the
manufacturer

* Per guidance, the volume of sales needs to be provided for various sizes, models, and configurations of the device, as applicable.
† Per guidance, the PMS data need to be presented; “the device (Basic UDI-DI), device group (CMD), or device group/family level (legacy devices). When justified,
the data can be presented for combinations of devices, for example, a device and its accessory.” The guidance recommends using a tabular format for presentation
of PMS data covering a period of the last 4 years (NOTE: This is not mandatory). Further, data need to be split by region (as applicable) – European Economic
Area (EEA), Turkey (TR), Northern Ireland (XI), and worldwide. It is recommended to use a tabular format for presentation of PMS data covering a period
of the last 4 years.
‡ Information regarding serious adverse events needs to be reported using the following Medical Device Regulators Forum (IMDRF) Adverse Event
Terminology [AET], when available:
• IMDRF AET – Annex A for serious incidents • IMDRF AET – Annex C for cause of incidents • IMDRF AET – Annex D for health effects of the incidents

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How do I submit a PSUR?
Once prepared, a PSUR needs to be submitted to the notified body via an electronic
system (i.e., EUDAMED) or made available during notified body surveillance audits or
upon request, based on the nature and classification of the device. For Class III
devices or implantable devices falling under Class IIa and Class IIb, the PSUR needs to
be submitted via EUDAMED, whereas, for non-implantable devices falling under
Class IIa and Class IIb, the PSUR needs to be made available during notified body
surveillance audits. For custom-made devices, the PSUR needs to be made available
to the notified body upon request. As EUDAMED is not functional yet, the mode of
submission for PSURs to be submitted online (i.e., for Class III and implantable
devices) needs to be discussed with the notified body.

Conclusion
This whitepaper breaks down the PSUR requirements laid down by
Article 86 of the EU MDR based on the guidance document – MDCG
2022-21. While key elements like device classification, MDR transition
status, nature/characteristics of devices (for grouping them together
in a single PSUR) play an important role in determining the
applicability of PSUR requirements, it is also important to strategically
plan the timeline and data collection period of the PSUR and all
overlapping MDR deliverables ahead of time, so that all relevant
information can be leveraged across the documents. This will also
enable a contiguous data collection period until the end of the PSUR
requirement. A well-planned timeline will assist in a smooth execution
of the MDR transition and future updates.

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Key recommendations from Cactus Life Sciences
Table 2 below provides a gist of all the recommendations that are provided
by Cactus Life Sciences in this whitepaper.

Table 2: Cactus Life Sciences’ key recommendations for a PSUR

Topic Recommendations from Cactus Life Sciences

Early planning Requires strategic planning ahead of time, so that all documents in
the technical documentation can be aligned and the time constraints
described in the MDR are met.

Grouping of devices It is important to plan the scope of a PSUR and define the leading
with leading device device well in advance, so that PMS data for all applicable devices
can be streamlined and the schedule of PMS activities can be defined.

Data collection period
• Suggestion to establish the data collection period in the PSUR
finishing 12 months or 24 months (depending on the classification)
after the end date of the collection period of clinical data in the last
CER (e.g., in the literature search report).
• Considering that PMS, PMCF, CER, and SSCP (if applicable) are
completely connected and shall have their contents aligned,
we recommend defining a single data collection period for all
these activities that shall be contiguous over the following years.
• The frequency for future updates needs to be planned in contiguous
sequence per the requirements stated in the guidance document.

PSUR submission • As EUDAMED is not functional yet, the mode of submission for
PSURs to be submitted online (i.e., for Class III and implantable
devices) needs to be discussed with the notified body.
• The PSURs will be required even after the EC/EU certificates have
expired or the devices are no longer commercialized under a valid
EC/EU certificate. The lifetime of devices must be defined.

This whitepaper was co-authored by Merin A. Thomas (Scientific Writer II, Cactus Life Sciences), Ridhima
Kumar (Sr. Manager, Scientific Writing, Cactus Life Sciences), and Alexandre Pétiard (Medical Director,
Medical Devices, Cactus Life Sciences).

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 About Cactus Life Sciences

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All registered trademarks are property of their respective owners.

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