Understanding Post-market Surveillance under EU MDR: Being Proactive, not Reactive

Understanding Post-
market Surveillance
under EU MDR
Being Proactive, not Reactive
3 June 2020

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3
Director of QA/RA
PresenterModerator
Carolyn Guthrie
Senior Medical
Device Guru
Jesseca Lyons
© Copyright 2020 Kapstone Medical, LLC

INSPIRE | GUIDE | EQUIP
4

Agenda
• PMS Requirements
• Integrating into your current QMS
• Impact to your business
• Relationship between PMS, Risk Management & Clinical
Evaluation
• PMS Plans and Reports
5

What are the current requirements?
• European Union (EU) Medical Device Directives 93/42/EEC,
Annex II
• … an undertaking by the manufacturer to institute and keep up to
date a systematic procedure to review experience gained from
devices in the post-production phase
• and to implement appropriate means to apply any necessary
corrective action.
• Codified from MEDDEV and NB-MED documents
• MEDDEV 2.12/1 rev 8 – Vigilance
• MEDDEV 2.12/2, rev 2 - PMCF
• MEDDEV 2.7/1, rev 4 – Clinical Evaluation
• NB-MED 2.12 rec 1 - PMS
6

What are the current requirements?
• ISO 13485:2016 Section 8.2 Monitoring and Measurement
• § 8.2.1 Feedback:
…The organization shall document procedures for the feedback
process. This feedback process shall include provisions to gather
data from production as well as post-production activities.
The information gathered in the feedback process shall serve as
potential input into risk management for monitoring and
maintaining the product requirements as well as the product
realization or improvement processes.
If applicable regulatory requirements require the organization to
gain specific experience from postproduction activities, the review
of this experience shall form part of the feedback process.
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New requirements of PMS under MDR
System EU MDR
Post-market Surveillance (PMS) Article 83: Post-market surveillance system of the manufacturer
Risk Management ANNEX I,3(e) Risk management system
Clinical evaluation plan and report Annex XIV Clinical evaluation and post-market clinical follow-up
Post-market Surveillance plan and
report
Annex III: Technical documentation on post-market surveillance
Article 84: Post-market surveillance plan
Article 85: Post-market surveillance report (Class I)
Post-market clinical follow-up (PMCF)
plan and evaluation report
Annex XIV Clinical evaluation and post-market clinical follow-up
Periodic Safety Update Report
(PSUR)
Article 86: Periodic safety update report (Class IIa, IIb, III)
Summary of Safety and Clinical
Performance (SSCP)
Article 32: Summary of safety and clinical performance
Vigilance Article 87: Reporting of serious incidents and field safety corrective actions
Article 88: Trend reporting
Article 89: Analysis of serious incidents and field safety corrective actions
Article 90: Analysis of vigilance data
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• Article 2 Section 60: (Definitions)
‘post-market surveillance’ means all activities carried out by
manufacturers in cooperation with other economic
operators to institute and keep up to date a systematic
procedure to proactively collect and review experience
gained from devices they place on the market, make
available on the market or put into service for the purpose
of identifying any need to immediately apply any
necessary corrective or preventive actions
9

• Article 83: Post-market surveillance system of the manufacturer
1. For each device, manufacturers shall plan, establish,
document, implement, maintain and update a post-market
surveillance system in a manner that is proportionate to the risk
class and appropriate for the type of device. That system shall
be an integral part of the manufacturer's quality management
system referred to in Article 10(9).
2. 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.
10

Examples of PMS Data Sources
Proactive Reactive
Post-market clinical follow-up (PMCF) Complaints
Registries and registry studies NCRs and other issues in manufacturing
Experience with similar devices Service records
Focus groups Vigilance
Customer surveys and user feedback Literature reviews
National/regional registry reviews
11

What is this collection of data being
used for?
• Update:
(a) to update the benefit-risk determination and to improve the risk management as referred
to in Chapter I of Annex I;
(b) to update the design and manufacturing information, the instructions for use and the
labelling;
(c) to update the clinical evaluation;
(d) to update the summary of safety and clinical performance referred to in Article 32;
• Identify:
(e) for the identification of needs for preventive, corrective or field safety corrective action;
(f) for the identification of options to improve the usability, performance and safety of the
device;
• (g) when relevant, to contribute to the post-market surveillance of other devices; and
• (h) to detect and report trends in accordance with Article 88.
12

• Article 84: Post-market surveillance plan
The post-market surveillance system referred to in Article 83
shall be based on a post-market surveillance plan, the
requirements for which are set out in Section 1.1 of Annex III.
For devices other than custom-made devices, the
postmarket surveillance plan shall be part of the technical
documentation specified in Annex II.
13

Annex III – Tech Doc on PMS
• Defines technical requirements of the plan
• The post-market surveillance plan shall address the
collection and utilization of particular available
information
• The post-market surveillance plan shall cover processes,
methods, acceptance criteria.
14

What to include in your plan?
15
(a) The post-market surveillance plan shall address the collection
and utilization of available information, in particular:
• information concerning serious incidents, including information
from PSURs, and field safety corrective actions;
• records referring to non-serious incidents and data on any
undesirable side-effects;
• information from trend reporting;
• relevant specialist or technical literature, databases and/or
registers;
• information, including feedbacks and complaints, provided by
users, distributors and importers; and
• publicly available information about similar medical devices.

What to include in your plan?
16
(b) The post-market surveillance plan shall cover at least:
• a proactive and systematic process to collect any information referred to in point (a). The process shall allow
a correct characterisation of the performance of the devices and shall also allow a comparison to be made
between the device and similar products available on the market;
• effective and appropriate methods and processes to assess the collected data;
• suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit-risk
analysis and of the risk management as referred to in Section 3 of Annex I;
• effective and appropriate methods and tools to investigate complaints and analyse market-related
experience collected in the field;
• methods and protocols to manage the events subject to the trend report as provided for in Article 88,
including the methods and protocols to be used to establish any statistically significant increase in the
frequency or severity of incidents as well as the observation period;
• methods and protocols to communicate effectively with competent authorities, notified bodies, economic
operators and users;
• reference to procedures to fulfil the manufacturers obligations laid down in Articles 83, 84 and 86;
• systematic procedures to identify and initiate appropriate measures including corrective actions;
• effective tools to trace and identify devices for which corrective actions might be necessary; and
• a PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable.

• Article 85: Post-market surveillance report
• Manufacturers of class I devices shall prepare a post-
market surveillance report summarising the results and
conclusionsof the analyses of the post-market surveillance
data gathered as a result 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.
17

• Article 86 :Periodic safety update report
• 1. Manufacturers of class IIa, class IIb and class III devices shall prepare a periodic safety update report (‘PSUR’) for each
device and where relevant for each category or group of devices summarising the results and conclusions of the analyses of
the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 84 together
with a rationale and description of any preventive and corrective actions taken. Throughout the lifetime of the device
concerned, that PSUR shall set out:
• (a) the conclusions of the benefit-risk determination;
• (b) the main findings of the PMCF; and
• (c) 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.
• Manufacturers of class IIb and class III devices shall update the PSUR at least annually. That PSUR shall, except in the case of
custom-made devices, be part of the technical documentation as specified in Annexes II and III.
• Manufacturers of class IIa devices shall update the PSUR when necessary and at least every two years. That PSUR shall, except
in the case of custom-made devices, be part of the technical documentation as specified in Annexes II and III.
• For class III devices or implantable devices, manufacturers shall submit PSURs by means of the electronic system referred to in
Article 92 to the notified body involved in the conformity assessment in accordance with Article 52. The notified body shall
review the report and add its evaluation to that electronic system with details of any action taken.
• 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 in the conformity assessment and, upon request, to competent authorities
18

Summary of Report Timelines
19
Class I Class IIa Class IIb Class III Implantable
PMSR
PSUR
Throughout the lifetime of the device
As necessary
As necessary,
but at least
every 2 years
Annually
Make available to the Notified Body
Submit electronically to the Notified
Body
Make available to the Competent Authority on request
Made available to the Competent
Authority by the NC

• Article 88: Trend reporting
• 1. Manufacturers shall report, by means of the electronic system referred to in
Article 92, any statistically significant increase in the frequency or severity of
incidents that are not serious incidents or that are expected undesirable side
effects that could have a significant impact on the benefit-risk analysis referred to
in Sections 1 and 5 of Annex I and which have led or may lead to risks to the
health or safety of patients, users or other persons that are unacceptable when
weighed against the intended benefits. The significant increase shall be
established in comparison to the foreseeable frequency or severity of such
incidents in respect of the device, or category or group of devices, in question
during a specific period as specified in the technical documentation and product
information.
• The manufacturer shall specify how to manage the incidents referred to in the first
subparagraph and the methodology used for determining any statistically
significant increase in the frequency or severity of such incidents, as well as the
observation period, in the post-market surveillance plan referred to in Article 84.
20

Integrating into the QMS
• Article 10 General obligations of manufacturers
9. … The quality management system shall address at least
the following aspects:
(i) setting-up, implementation and maintenance of a post-
market surveillance system, in accordance with Article
83;
21

• It does not need to be complicated
• Process interaction flowchart
• Linkages with the following:
• Design and Development (where post-market surveillance information may be relevant for
products in development)
• Feedback and Complaint Handling
• Field Action (Recalls and Safety Notices)
• Management Review
• Risk Management
• Technical Documentation
• Labeling
• Clinical Evaluation
• Corrective and Preventive Action
• Periodic Safety Update Report (if applicable, a new requirement of the EU MDR)
• Summary of Safety and Clinical Performance (if applicable, another new requirement of the
EU MDR)
• Regulatory Communication
22

Example of a Process Flow Chart
23

• It does not need to be complicated
• Common terminology
• Process interaction flowchart
• Linkages with the following:
• Design and Development (where post-market surveillance information may be relevant for products in
development)
• Feedback and Complaint Handling
• Field Action (Recalls and Safety Notices)
• Management Review
• Risk Management
• Technical Documentation
• Labeling
• Clinical Evaluation
• Corrective and Preventive Action
• Periodic Safety Update Report (if applicable, a new requirement of the EU MDR)
• Summary of Safety and Clinical Performance (if applicable, another new requirement of the EU MDR)
• Regulatory Communication
24

Proportionate Risk
25
• A post-market surveillance system in a manner that is
proportionate to the risk class and appropriate for the
type of device
• Consider:
• History of clinical performance of this device (and/or similar
devices on the market)
• Intended use
• The maturity stage of the device

What is the impact to the business?
• (32) To ensure that devices manufactured in series
production continue to be in conformity with the
requirements of this Regulation and that experience from
the use of the devices they manufacture is taken into
account for the production process, all manufacturers
should have a quality management system and a post-
market surveillance system in place which should be
proportionate to the risk class and the type of the device
in question. In addition, in order to minimize risks or prevent
incidents related to devices, manufacturers should
establish a system for risk management and a system for
reporting of incidents and field safety corrective actions.
26

(34) It should be ensured that supervision and control of the
manufacture of devices, and the post-market surveillance
and vigilance activities concerning them, are carried out
within the manufacturer's organisation by a person
responsible for regulatory compliance who fulfils minimum
conditions of qualification.
27

28
• Timeline for implementation (May 2021)
• Resources for performing the collecting and evaluation of
data, and writing of reports
• Resources to perform documentation updates (risk,
clinical evaluation, technical documentation)
• Not limited to regulatory
• Impact to other economic operators

Resource Requirements
29
For example:
• Quality Assurance
• Gather data
• CAs/PAs
• Regulatory
• Vigilance
• PSUR
• Clinical Affairs
• Analyze PMCF

30
• Timeline for implementation (May 2021)
• Resources for performing the collecting and evaluation of
data, and writing of reports
• Resources to perform documentation updates (risk,
clinical evaluation, technical documentation)
• Not limited to regulatory
• Impact to other economic operators

Relationship between PMS, Risk
Management and Clinical Evaluation
• Risk Management feeds into PMS and Clinical Evaluation
• Clinical Evaluation feeds into Risk Management and PMS
• PMS feeds into Clinical Evaluation and Risk Management
31

Relationship between PMS, Risk
Management and Clinical Evaluation
• Risk Management feeds into PMS and Clinical Evaluation
• Risk Assessment on your device (estimations of severity and frequency;
pre-market)
• Clinical Evaluation feeds into Risk Management and PMS
• CER will confirm what was estimated during the risk assessment (pre-
market)
• State of the Art in CER (pre-market)
• Provides inputs into what to consider for the PMS plans, which include
the PMCF plans (input into post-market activities)
• PMS feeds into Clinical Evaluation and Risk Management
• Performing PMS activities will result in PMCF data, periodic safety
update report
• Continuous update of estimations of risk (severity and frequency)
32

Risk Management in MDR (as related
to PMS)
• Annex 1 General Safety and Performance Requirements
• 3. Manufacturers shall establish, implement, document and
maintain a risk management system.
• Risk management shall be understood as a continuous
iterative process throughout the entire lifecycle of a device,
requiring regular systematic updating.
• (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;
33

Integrating PMS into Risk
Management (ISO 14971)
Risk Phase Activities
Risk Management Planning •Define risk ratings, risk grids, risk acceptance criteria
•Define risk management deliverables including human factors studies
•Define plan for post-launch risk management
Output: Post-market surveillance plan
Risk Assessment (Risk
Analysis & Risk Evaluation)
Identification of known and foreseeable hazards in both normal and fault conditions;
Estimation of risks for each hazardous situation; literature /standards, human factors
Inputs: Monitor production / post production data (Complaint investigations, MDRs,
recalls, safety alerts) to re-estimate risk and ensure residual risk remains acceptable.
Outputs: Action System, CAPA, Field Action; Management Reviews
Risk Control •Risk control option analysis & Implementation of risk control measures;
•Residual Risk assessment; New risks arising from risk control measures
•On-going assessment of Production / Post Production Information; Monitor need for
additional control measures.
•Post-Market Clinical Follow-up (PMCF) studies; Clinical Evaluations / Periodic Risk Benefit
Analyses
Outputs: Updates to risk files; triggers for safety alerts;
34

Clinical Evaluation in MDR (as related
to PMS)
• Article 61 Clinical evaluation
9. In the case of the products without an intended medical purpose listed in
Annex XVI, the requirement to demonstrate a clinical benefit in accordance
with this Chapter and Annexes XIV and XV shall be understood as a
requirement to demonstrate the performance of the device. Clinical
evaluations of those products shall be based on relevant data concerning
safety, including data from post-market surveillance, PMCF, and, where
applicable, specific clinical investigation. Clinical investigations shall be
performed for those products unless reliance on existing clinical data from
an analogous medical device is duly justified.
11. The clinical evaluation and its documentation shall be updated
throughout the life cycle of the device concerned with clinical data
obtained from the implementation of the manufacturer's PMCF plan in
accordance with Part B of Annex XIV and the post-market surveillance plan
referred to in Article 84.
35

Post-market Clinical Follow-up
• Annex XIV Part B Post-market Clinical Follow-up
• 5. PMCF shall be understood to be a continuous process
that updates the clinical evaluation referred to in Article
61 and Part A of this Annex and shall be addressed in the
manufacturer's post-market surveillance plan.
36

Summary
• May 2021 enforcement date
• Procedures
• Plans
• Process
• Reports
37

Questions?
38

Contact Information
Kapstone Medical, LLC
520 Elliott Street
Charlotte NC 28210
Info@KapstoneMedical.com
www.KapstoneMedical.com
+1 (704) 843-7852

Understanding Post-market Surveillance under EU MDR: Being Proactive, not Reactive

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