MDR READINESS

HOW TO BE COMPLIANT WITH THE MDR

POST MARKET ACTIVITIES AND
REPORTS?

Prepared by the Medtech Europe PMS-WG

1 March 2018
 Objective of this training module

• This training module results from the discussions and

analysis made by the Post Market Working Group of
Medtech Europe.
• This document is not an offical document and
represents our current interpretation of the
regulations
• It is provided for reference and training only, and shall
always be consulted in regards of the actual
regulation text.

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 PMS System and PMS Plan
• Under the Regulation, a post market surveillance plan demonstrating
implementation of the PMS system needs to be established for each
device/ family of device. The plan will define the data to be analyzed
as well as the methods of analysis with the purpose of characterizing
the safety and performance of the device, or device family, with
similar devices in the market.

• PMS System governance

• PMS data collection
• PMS data analysis
• safety and performance assessment

Note: PMS plan covers CE mark devices, manufacturer may decide to

include European data or worldwide data to the PMS Plan

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 DYNAMIC OVERVIEW OF PMS CYCLE (*)

(*) Courtesy BSI

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 POST MARKET SURVEILLANCE PLAN - MDR
Post-Market Clinical Follow- Post-Market Clinical Follow-
Up (PMCF) Plan - Annex XIII Up Report – Updated
Part B* Post Market Surveillance Plan Annually

Class 1 All Classes Class IIa/b & III

Periodic Safety Update

Clinical Evaluation Report
Report Class IIb & III updated at least
Class 1

Post-Market annually. Class IIa every 2 years

Class III – Submit to NB via
Surveillance Updated annually driven by PMCF
electronic system
Report
Report Other classes - made available to
NB and on request to CA
Updated when necessary Class III+Implant Class III+Implant
Available to CA on request

Summary of Safety & Clinical Performance

Published by NB on EUDAMED – Publicly Available

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 CLINICAL EVALUATION REPORT
PMS & MDR Update EUDAMED/ Extract MDR ( not comprehensive)
Vigilance Article re- Frequency Accessibility
Documents ferences
Clinical 61-12, Significant No EUDAMED, The results of the clinical evaluation and the
Evaluation Annex XIV/ risk/not Part of clinical evidence on which it is based shall be
Report (CER) PartA-4 established: technical documented in a clinical evaluation report which
(MEDDEV annually for documentation shall support the assessment of the conformity
2.7.1/ class III and of the device. The clinical evidence together with
Rev.4) implants non-clinical data generated from non-clinical
testing methods and other relevant
otherwise: documentation shall allow the manufacturer to
2-5 years demonstrate conformity with the general safety
(acc. to and performance requirements and shall be part
sec.6.2.3a of the technical documentation for the device in
of MEDDEV question. Both favorable and unfavorable data
2.7.1 considered in the clinical evaluation shall be
included in the technical documentation.

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 CLINICAL INVESTIGATION REPORT
PMS & MDR Update EUDAMED/ Extract MDR ( not comprehensive)
Vigilance Article re- Frequency Accessibility
Documents ferences
Clinical Annex XIV ad hoc Yes- Irrespective of the outcome of the clinical
Investigation Art 77-5 summary investigation, within one year of the end of the
Report clinical investigation or within three months of the
early termination or temporary halt, the sponsor shall
submit to the Member States in which a clinical
investigation was conducted a clinical investigation
report as referred to in Section 2.8 of Chapter I and
Section 7 of Chapter III of Annex XV. The clinical
investigation report shall be accompanied by a
summary presented in terms that are easily
understandable to the intended user. Both the report
and summary shall be submitted by the sponsor by
means of the electronic system referred to in Article
73. Where, for scientific reasons, it is not possible to
submit the clinical investigation report within one
year of the end of the investigation, it shall be
submitted as soon as it is available. In such case, the
clinical investigation plan referred to in Section 3 of
Chapter II of Annex XV shall specify when the results
of the clinical investigation are going to be available,
together with a justification.
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 PMCF EVALUATION REPORT
PMS & MDR Update EUDAMED/ Extract MDR ( not comprehensive)
Vigilance Article re- Frequency Accessibility
Documents ferences
PMCF 61-11, Implantable No EUDAMED, For class III devices and implantable devices, the
evaluation Annex XIV, and Class Part of CER PMCF evaluation report and, if indicated, the
report PartB-7 III: at least and therefore summary of safety and clinical performance
annually technical referred to in Article 32 shall be updated at least
documentatio annually with such data.
n, basis for
SSCP
The manufacturer shall analyse the findings of the
PMCF and document the results in a PMCF
evaluation report that shall be part of the clinical
evaluation report and the technical
documentation. 8. The conclusions of the PMCF
evaluation report shall be taken into account for
the clinical evaluation referred to in Article 61 and
Part A of this Annex and in the risk management
referred to in Section 3 of Annex I. If, through the
PMCF, the need for preventive and/or corrective
measures has been identified, the manufacturer
shall implement them.

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 SUMMARY OF SAFETY AND CLINICAL PERFORMANCE
PMS & MDR Update EUDAMED/ Extract MDR ( not comprehensive)
Vigilance Article re- Frequency Accessibility
Documents ferences
Summary of 32, 83-3(d) Implantable EUDAMED: 1.For implantable devices and for class III devices, other than custom-made
Safety and and class III: publicly or investigational devices, the manufacturer shall draw up a summary of
safety and clinical performance. The summary of safety and clinical
Performance annually if available
performance shall be written in a way that is clear to the intended user and,
(SSCP) indicated if relevant, to the patient and shall be made available to the public via
Eudamed. The draft of the summary of safety and clinical performance shall
be part of the documentation to be submitted to the notified body involved
in the conformity assessment pursuant to Article 52 and shall be validated
by that body. After its validation, the notified body shall upload the
summary to Eudamed. The manufacturer shall mention on the label or
instructions for use where the summary is available
.2.The summary of safety and clinical performance shall include at least the
following aspects: (a) the identification of the device and the manufacturer,
including the Basic UDI-DI and, if already issued, the SRN; (b) the intended
purpose of the device and any indications, contraindications and target
populations; (c) a description of the device, including a reference to
previous generation(s) or variants if such exist, and a description of the
differences, as well as, where relevant, a description of any accessories,
other devices and products, which are intended to be used in combination
with the device; (d) possible diagnostic or therapeutic alternatives; (e)
reference to any harmonised standards and CS applied; (f) the summary of
clinical evaluation as referred to in Annex XIV, and relevant information on
post-market clinical follow-up; (g) suggested profile and training for users;
(h) information on any residual risks and any undesirable effects, warnings
and precautions.
3.The Commission may, by means of implementing acts, set out the form
and the presentation of the data elements to be included in the summary of
safety and clinical performance. Those implementing acts shall be adopted
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 RISK MANAGEMENT REPORT
PMS & MDR Update EUDAMED/ Extract MDR ( not comprehensive)
Vigilance Article re- Frequency Accessibility
Documents ferences
Risk Chapter 1 systemati N/A Manufacturers shall establish, implement, document
Manageme Annex I c update and maintain a risk management system. Risk
nt Report management shall be understood as a continuous
iterative process throughout the entire lifecycle of a
device, requiring regular systematic updating. In carrying
out risk management manufacturers shall: (a) establish
and document a risk management plan for each device;
(b) identify and analyse the known and foreseeable
hazards associated with each device; (c) estimate and
evaluate the risks associated with, and occurring during,
the intended use and during reasonably foreseeable
misuse; (d) eliminate or control the risks referred to in
point (c) in accordance with the requirements of Section
4; (e) evaluate the impact of information from the
production phase and, in particular, from the post-
market surveillance system, on hazards and the
frequency of occurrence thereof, on estimates of their
associated risks, as well as on the overall risk, benefit-
risk ratio and risk acceptability; and (f) based on the
evaluation of the impact of the information referred to
in point (e), if necessary amend control measures in line
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with the requirements of Section 4.
 PMS REPORT
PMS & MDR Update EUDAMED/ Extract MDR ( not comprehensive)
Vigilance Article re- Frequency Accessibility
Documents ferences
PMS report 85 Class I: No EUDAMED, Manufacturers of class I devices shall prepare a
update ‘make post-market surveillance report summarising the
when available’ to results and conclusions of the analyses of the
necessary CA upon post-market surveillance data gathered as a result
request of the post-market surveillance plan referred to in
Article 84 together with a rationale and
description of any preventive and corrective
actions taken. The report shall be updated when
necessary and made available to the competent
authority upon request.

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 PERIODIC SAFETY UPDATE REPORT
PMS & MDR Article Update EUDAMED/ Extract MDR ( not comprehensive)
Vigilance references Frequency Accessibility
Documents
Periodic Safety 86-2, 86-3, EUDAMED : only 1. Manufacturers of class IIa, class IIb and class III devices shall prepare a
Update Report 92-1(d) available for periodic safety update report (‘PSUR’) for each device and where
relevant for each category or group of devices summarising the results
(PSUR) only class III for and conclusions of the analyses of the post-market surveillance data
contains: NB and CA gathered as a result of the post-market surveillance plan referred to in
No EUDAMED Article 84 together with a rationale and description of any preventive
1. Benefit-risk accessibility and corrective actions taken. Throughout the lifetime of the device
concerned, that PSUR shall set out: (a) the conclusions of the benefit-risk
determination needed for Class
determination; (b) the main findings of the PMCF; and (c) the volume of
II devices sales of the device and an estimate evaluation of the size and other
2. Main characteristics of the population using the device and, where
findings of Class IIb and practicable, the usage frequency of the device. Manufacturers of class IIb
PMCF and class III devices shall update the PSUR at least annually. That PSUR
III: at least shall, except in the case of custom-made devices, be part of the technical
annually documentation as specified in Annexes II and III. Manufacturers of class
3. […] IIa devices shall update the PSUR when necessary and at least every two
population Class IIa: at years. That PSUR shall, except in the case of custom-made devices, be
using the part of the technical documentation as specified in Annexes II and III. For
least every custom-made devices, the PSUR shall be part of the documentation
device […] 2 years referred to in Section 2 of Annex XIII.
2. For class III devices or implantable devices, manufacturers shall submit
4. Summary of PSURs by means of the electronic system referred to in Article 92 to the
PMS data notified body involved in the conformity assessment in accordance with
gathered acc. Article 52. The notified body shall review the report and add its
evaluation to that electronic system with details of any action taken.
to PMS plan Such PSURs and the evaluation by the notified body shall be made
available to competent authorities through that electronic system.
3. For devices other than those referred to in paragraph 2,
manufacturers shall make PSURs available to the notified body involved
proprietary and confidential - do not distribute in the conformity assessment and, upon request, to competent
authorities.
 VIGILANCE REPORTS

- Individual vigilance report (Article 87)

- Periodic Summary Report (Article 86)
- Trend reporting (Article 88)
- FSCA Report (Article 87- 89)
- Electronic system for PMS and Vigilance (Art 92)

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 POST MARKET SURVEILLANCE REPORTS - MDR
Report Class I Class IIa Class IIb Class III/
implants
Clinical Evaluation When needed 2-5 years 2-5 years annually
report
61-12 / Annex XIV part
A-4/ meddev 2.7.1 rev4

PMCF Evaluation report When needed When needed or at When needed or At least annually
- part of the CER least 2-5 years at least 2-5 years
61-11 Annex XIV PartB-
7

Summary of safety and N/A Every 2 years Every 2 years annually

clinical performance
32,83-3(d)

Risk Management Regular Regular systematic Regular systematic Regular systematic

Report systematic update update update
Annex I . Chapter 1- 3 update

PSUR N/A At least every 2 At least annually At least annually

86-2,86-3,92-1(d) years
PMS report When necessary
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N/A N/A N/A
Art 85
 AREAS TO CONSIDER FOR COMPLIANCE
PMS System 2

Technical documentation

PMS Plan 3 PMCF Plan Clinical Evaluation Plan Risk

Management
Periodic Safety Clinical Evaluation
1 Plan
Update Report Report
- PSUR Summary of Safety Risk
4 PMCF and Clinical
Management
PMS Report Report Performance - SSCP
Report
Clinical Investigation
Vigilance Report Report

5
FSCA Report
Trend Report
Eudamed
Periodic 6
Summary Report

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 INITIAL ACTIVITIES TO BE INITIATED FOR
COMPLIANCE

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 CLINICAL EVIDENCE AND THE DEVICE LIFECYCLE
• Reviewing the lifecycle activities and their connections in the
quality management system (QMS), in particular the
connections between the risk management, generation of
clinical evidence, PMS and the maintenance of the technical
documentation
• Establishing the linkage mechanisms between the risk
management plan, clinical evaluation plan, PMCF plan, PMS
plan and their associated reports, how they feed into the
technical documentation, and how they are maintained to be
consistent throuhout the lifecycle of the device.
• Establish yearly assessment of CER
• Use Risk Management Plan as the “mother” document in the
hiearchy of reports

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 PMS SYSTEM
• Reviewing PMS activities against the requirements of the Regulation and
identifying any gaps to be filled;
• Documenting an overview of the future PMS system and the links to specific
documented procedures for executing its elements;
• Including the documented overview of the PMS system within the QMS;
• Identifying the role that will act as the person responsible for regulatory
requirements and the requirements for that position;
• Updating the job description and job requirements for the person responsible for
regulatory requirements
• Time schedule for update of the various reports; by product of the portfolio
• Consider automated software tool for Eudamed filing
• Establish strategic portfolio management
• Establish the PMS system as a high level procedure in QMS

(*) Courtesy BSI

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 PMS PLAN

• Establishing a template for the future PMS plan;

• Establish plan by product or product family
• Establish trigger for revising reports
• Identifying a sequence for creating or updating PMS
plans into the new template for the portfolio of
device;
• Creating or updating PMS plans and incorporating
the plans into the technical documentation.
• Map the existing plans

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 PMSR / PSUR
• Reviewing current reports of PMS activities against the requirements of
the regulations and identifying any gaps;
• Creating template(s) for PSUR or PMS reports, as applicable;
• Establish the level of detail needed in the data provided
• Define who needs to provide input
• Creating documented procedure(s) for creation of the PSURs or PMS
reports, as applicable, together with the associated roles and
responsibilities;
• Estimating the number of PSURs or PMS reports that will need to be
prepared and the frequency at which they will need to be updated;
• Establishing a timeline for creating or updating PSURs or PMS reports, as
applicable; and,
• Confirming the availability of the necessary resources.

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 COMPLAINTS AND VIGILANCE
• Reviewing the current procedures for vigilance against the requirements in
the Regulations and identify any gaps;
• Determining the methods to establish statistical increases in frequency
and severity for trend reporting;
• Reviewing a sample of previous vigilance reports against the revised
exemption rules and timelines to estimate the likely increase in reporting
that could result; including reduction of the reporting exemption
• Reviewing resources for vigilance reporting against the projected future
workload;
• Identifying the changes needed to processes for complaint handling and
vigilance reporting and the timeline for their implementation.
• Ensure consistency of the data provided to CA with other reports (e.g.
Sales data)

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 ELECTRONIC SUBMISSION

• Establishing mechanisms to remain informed of the

development of Eudamed, including the timelines and
interface requirements;
• Reviewing procedures to establish internal processes,
including responsibility and authority for the preparation and
review of electronic submissions.
• Consider a one time submission of data that is to be provided
across all reports (e.g. Product description, intended use, date
of putting on the market etc)
• Learn from/ benchmark with pharma companies as they
report electronically
• UDI: use experience from FDA
• Prepare and communicate with IT department
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