Module 16 2024
Module 16 : Post-Market Surveillance and Vigilance for Medical Devices Date: 23 rd – 25 th Octo ber 2024 Module: 16 of the TOPRA MSc Data Management and Digitalisation in Regulatory Affairs Module Leader: Adrian Keene & Paul Risborough
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Module 16 - Post Market Surveillance and Vigilance for Medical Devices
Location: TOPRA Office, 6 th Floor, 3 Harbour Exchange, London E14 9GE and online
Module Leader : Adrian Keene & Paul Risborough
Date: Wednesday 23 rd October 2024
Time
Activity
Speaker
13:00
Registration and Welcome and Introduction
13.30 – 15.00
Lecture 1: Where are we with the MDR?
Stephan Buttron
PMS European Requirements
Buttron Consulting
New Legislation Vs Current
New Legislation Vs Current Refreshment Break
15.00 – 15.30
Lecture 2: Unique Device Identification & Traceability in healthcare • UDI • EUDAMED and Databases • Traceability • Module requirements and availability
15:30 – 17:00
Jenny Young-Gough
JYG Consulting
Module 16 - Post Market Surveillance and Vigilance for Medical Devices
Date : Thursday 24th October 2024
Time
Activity
Speaker
Lecture 3: Post-market surveillance requirements under the MDR (EU) 2017/745
09:00 – 10:00
Paul Risborough
NAMSA
10.00 – 10.30
Refreshment Break
10.30 – 11.30
Lecture 4: The role and responsibilities of Notified Bodies in Vigilance and Post-market Surveillance
Monisha Phillips
TUV SUD
11.30 – 12.30
Lunch
12.30 – 13.30
Lecture 5 : Post-market surveillance, risk assessment and corrective/preventative action
Paul Risborough
NAMSA
13.30 – 14.30
Case Study: Assessing complaints
David Mandley
NAMSA
14.30 - 15.00
Refreshment Break
15.00 - 16.00
Lecture 6: Periodic Safety Update Report (PSUR)
David Mandley
NAMSA
16.00 - 17.00
Lecture 7: Post-market Clinical Follow-up (PMCF)
Adrian Keene
NAMSA
Module 16 - Post Market Surveillance and Vigilance for Medical Devices
Date: Friday 25 th October 2024
Time
Activity
Speaker
09.30 – 10.30
Lecture 8: Vigilance Reporting – an Agency perspective • Common issues and pitfalls to avoid • Reporting of serious incidents and field safety corrective actions • Transparency schemes • Borderline issues on Medical Devices
Vicky Cracknell
MHRA
10.30 – 11.00
Refreshment Break
11.00 – 12.30
Lecture 9: Post Market Surveillance - Legal Considerations • Criminal and administrative liabilities • Considerations for listed companies • Public Relations
Grant Castle
Covington & Burling LLP
12:30 – 13:30
Lunch
13.30 – 15.00
Lecture 10: Field Safety Corrective Actions - Legal Considerations • Field safety corrective actions • Safeguard measures • Product liability
Grant Castle
Covington & Burling LLP
15.00 – 15.30
Close of Module
10/17/2024
Where are we with the EU-MDR?
European Post-Market Surveillance Requirements
Stephan Buttron, Buttron Consulting Berlin, Germany
^
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Agenda
• Summary of current EU-MDR Regulatory Framework
MDR Extensions Timelines and Milestones
•
Article 83 PMS System Requirements
•
Article 84 & Annex III PMS Planning
•
Article 85 & 86 PMS Reporting
•
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Annex XIV - Post-Market Clinical Follow Up
•
MDR Requirements for Economic Operators
•
OMS Guidance Document
•
Summary and Learning Outcome
•
Q&A
•
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MDR Regulatory Framework, Requirements and Key Changes
The EU-MDR is the European Union Medical Device Regulation 2017/745 and has replaced the former EU-Medical Device Directives (MDD & AIMDD) by the European Parliament and the Council of the European Union.
The intent of the EU MDR regulations is to ensure a high standard of safety and quality for medical dev ices that are produced in, or distributed in the the European Economic Area (EEA).
This new EU regulation is the current European regulatory framework for medical devices intended to sustainably ensure patient health & safety while still encouraging medical device innovation.
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https://advisera.com/13485academy/what-is-eu-mdr/
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MDR Regulatory Framework, Requirements and Key Changes
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2022 © TÜV SÜD AG/MKG/MHS/41.0/en/SG
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MDR Extended Transition Timeline
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Source: Modified infographic from European Commission Presentation on IMDRFMeeting 09SEP24
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Why was an extension timeline needed?
The resources of qualified NBs in 2022 was not sufficient to transfer all existing medical device certificates into the MDR during the initial transition timeline.
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Why was an extension timeline needed?
The resources of qualified NBs in 2022 was not sufficient to transfer all existing medical device certificates into the MDR during the initial transition timeline.
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Major Obstacles and Business Risks
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MDR Extended Transition Timeline
Only Medical Devices covered by a valid
Notified Body Certificate or a Manufacturer’s
Declaration of Conformity issued before 26
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May 2021 can potentially benefit from the
extended transition period!
Source: Modified infographic from European Commission Presentation on IMDRFMeeting 09SEP24
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MDR Extended Transition Timeline
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Source: Modified infographic from European Commission Presentation on IMDRFMeeting 09SEP24
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MDR Extended Transition Timeline
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Source: Modified infographic from European Commission Presentation on IMDRFMeeting 09SEP24
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MDR Extended Transition Timeline
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Source: Modified infographic from European Commission Presentation on IMDRFMeeting 09SEP24
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MDR Extended Transition Timeline
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Source: Modified infographic from European Commission Presentation on IMDRFMeeting 09SEP24
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MDR Extended Transition Timeline
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Source: Modified infographic from European Commission Presentation on IMDRFMeeting 09SEP24
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Important Definitions – Significant Changes
Following MDR Article 120 significant changes are those device modifications that are not allowed in the extended transition period for devices covered by Notified Body certificates issued under the replaced MDD/AIMDD.
- Significant Design Changes - Intended Use/Indications for Use
MDCG 2020-03 Guidance defines in detail what can be considered significant changes or not.
It is important to mention that QMS documentation shall be aligned with these requirements and the change control procedure shall include the requirements mentioned within this guidance document.
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MDR Regulatory Requirements and Key Changes
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Overview of MDR Post-Market Requirements
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Post-Market Surveillance - Definitions
Chapter I Scope and Definitions Article 2 Definitions – ‘post market surveillance’
(60) ‘ 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;
(61) ‘ market surveillance ’ means the activities carried out and measures taken by competent authorities to check and ensure that devices comply with the requirements set out in the relevant Union harmonization legislation and do not endanger health, safety or any other aspect of public interest protection;
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Overview of MDR PMS Requirements
During the MDR transitional period, new and legacy medical devices must comply with post-market surveillance requirements of the MDR.
MDCG 2021-25 states that this includes post-market surveillance reports (PMS reports) and periodic safety update reports (PSURs) for legacy devices as well Vigilance reporting, Collection of PMCF and/or clinical data Registration of the device and economic operator in EUDAMED. MDR Requirement Application to Medical Devices Art. 10 Section 9 (10) Manufacturers of devices shall implement and keep up to date the post-market surveillance system in accordance with Article 83. Art. 83, 84 – PMS system and PMS plan YES (with exception of requirements that relate to non-applicable obligations, e.g. Art. 83(3)(d) – SSCP; no requirement for a full revision of the technical documentation in accordance with Annexes II and III) Art. 85 – PMS report (class I devices) YES (classification of devices in class I following classification rules of the MDD, i.e. Art. 85 applies to class I ‘legacy devices’ despite the fact that those devices might be in a higher class under the MDR) Art. 86 – PSUR (class IIa, IIb and III devices) YES (manufacturers shall draw up and update PSURs; to be taken into consideration by notified body designated under AIMDD/MDD in the framework of surveillance audits, see further explanations above in the text)
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Overview of MDR PMS Requirements
MDR Requirements
Application to Medical Devices
Art. 87 – reporting of serious incidents
YES
Art. 88 – trend reporting
YES (trend reporting was already part of the vigilance system established under the MDD/AIMDD)
Art. 89 – Analysis of serious incidents and FSCA
YES
Art. 90 – Analysis of vigilance data
YES
Art. 91 – Implementing acts
YES
Art. 92 – EUDAMED vigilance module
In principle YES, but in the absence of EUDAMED’s full functionality, specific transitional provisions apply in accordance with Art. 122, 123(3)(d)(e)
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MDR - Post-Market Surveillance System - General Requirements
Post Market Surveillance – Article 83 Section 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.
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MDR - Post-Market Surveillance System - General Requirements
Post Market Surveillance – Article 83 Section 2
The post-market surveillance system shall be suited • to actively and systematically gathering, recording and analyzing 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.
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MDR - Post-Market Surveillance System - General Requirements
Article 83 Section 3
3. Data gathered by the manufacturer's post-market surveillance system shall in particular be used to update:
▪ (a) the benefit-risk determination and to improve the risk management as referred to in Chapter I of Annex I;
▪ (b) the design and manufacturing information , the instructions for use and the labelling ;
▪ (c) the clinical evaluation;
▪ (d) the summary of safety and performance for implants and Class III devices;
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MDR - Post-Market Surveillance System - General Requirements Article 83 Section 3 continued Data gathered by the manufacturer's post-market surveillance system shall in particular be used:
(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 [ Trend Reporting ].
The technical documentation shall be updated accordingly .
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MDR - Post-Market Surveillance System - General Requirements Article 83 Section 4
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MDR - Post-Market Surveillance System - General Requirements
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MDR - Art. 84 & Annex III: Post-market surveillance plan
The post-market surveillance system referred to in Article 83 shall be based on a product
[family] specific post-market surveillance plan.
For devices other than custom-made devices , the post- market surveillance plan shall be
part of the technical documentation specified in Annex III [ Technical Documentation on
Post-Market Surveillance]
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MDR - Art. 84 & Annex III: Post-market Surveillance Plan
Shall address the collection and utilisation of available information, in particular: • Serious incidents and information including information from PSUR and FSCA
• Records of non-serious incidents and undesirable side-effects
• Information from Trend reporting
• Relevant specialist, literature, databases and/or similar registers
• Feedback and complaints – from Users, Distributors and Importers
• Public information about similar medical devices
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MDR - Art. 84 & Annex III: Post-market surveillance plan
Shall cover at least: • proactive and systematic process to collect the information referred to in previous slide [EN ISO 13485:2016, 8.2.1]
• effective methods to assess the collected data (including complaints, market-related experience, trend reporting, recognise significant data) [EN ISO 13485:2016, 8.2 & 8.4]
• suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit-risk analysis and risk management [ ISO 14971:2019 and Annex I, SPR 3]
• Complaint investigation and analysis [ EN ISO 13485:2016, 8.2.2]
• Methods & protocols to manage events subject to the trend reporting regarding any statistically significate increase in the frequency or severity of incidents
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MDR - Art. 84 & Annex III: Post-market surveillance plan
Shall cover at least [continued]:
• Methods to communicate effectively with NB, CA, economic operators and users [EN ISO 13485 Sections 7.2.3 and 8.2.3]
• Reference to procedures to fulfil MDR PMS obligations [EN ISO 13485 Section 4.2]
• Procedures to initiate appropriate corrective measures/corrective actions [EN ISO 13485 Section 8.5
• Tools to trace and identify affected devices [ EN ISO 13485 Section 7.5.8. & 7.5.9]#
• PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not
applicable.
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MDR - Art. 84 & Annex III: Post-market surveillance plan
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Overview of MDR Post-Market Requirements
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Overview of MDR Post-Market Requirements
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Overview of MDR Post-Market Requirements
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MDR Post-Market Surveillance – A Product Life Cycle Approach
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Source: https://www.metecon.de/en/leistungen/clinical-affairs/pms/
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Overview of MDR PMS Reporting Requirements
Source: Modified Infographic derived from www.metecon.de/de/news/pms-und-pmcf-zur-gewinnung-klinischer-daten-bis-2020/u/1009/
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MDR Post-Market Surveillance – A Product Life Cycle Approach
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Article 86 – Periodic Safety Update Report (PSUR) 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: • the conclusions of the benefit-risk determination ; • the main findings of the PMCF; and • 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
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Article 86 – Periodic Safety Update Report (PSUR) – Best Practice?
The aim of the PSUR, as stated in MDCG 2022-21, is to provide a general overview • of the PMS activities , • the collected data and their analysis • along with a summary of all results and conclusions. When preparing the PSUR, it is very important to make a statement regarding the data validity in order to openly address limitations . Conclusions must be stated concerning about new (or emerging) risks or benefits and potential negative impacts on the benefit-risk assessment (see Annex I of MDCG 2022-21). The PMCF conclusions are an essential contribution to the ongoing confirmation of an acceptable benefit-risk profile , and emphasize the importance of properly integrating PMCF into PMS .
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Overview of MDR PMS Reporting Requirements
Medical Device Class
Type of Report
Update Frequency
Available to Notified Body
Class I
PMS Report
As necessary
As necessary but at least every second year
Class IIa
PSUR
Yes
Class IIb & III Class Ill and implantable devices
PSUR
Yes
As necessary but at least annually
PSUR
Uploaded to EUDAMED for Notified Body assessment
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Article 86 – Periodic Safety Update Report (PSUR)
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ANNEX XIV – CLINICAL EVALUATION AND POST-MARKET CLINICAL FOLLOW-UP
PART B: POST-MARKET CLINICAL FOLLOW-UP 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 . When conducting PMCF, the manufacturer shall proactively collect and evaluate clinical data from the use in or on humans of a device, with the aim of confirming the safety and performance throughout the expected lifetime of the device, of ensuring the continued acceptability of identified risks and of detecting emerging risks on the basis of factual evidence .
PMCF shall be performed pursuant to a documented metho d laid down in a PMCF plan or justified when not performing PMCF activities.
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Article 2 - Clinical Evidence, Evaluation and Data Scope and Definitions – Article 2 – Clinical Evidence
Clinical Evidence Art 2 (51 )
Clinical Evaluation Art 2 (44)
Clinical Data Art 2 (48)
• The clinical data and clinical evaluation report pertaining to a device • Sufficient amount and quality to allow a qualified assessment of whether the device achieves the intended clinical benefit(s) and safety, when used as intended by the manufacturer
• A systematic and planned process to continuously generate, collect, analyze and assess the clinical data pertaining to a device • To verify the safety and performance, including clinical benefit , of the device when used as intended by the manufacturer
• Clinical investigation on the device concerned • Clinical investigation reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated • Peer reviewed scientific literature on other clinical experience of either the device in question or a similar device for which equivalence can be demonstrated • Data from the manufacturer‘s post - market surveillance system, in particular post-market clinical follow- up
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Article 2 - Clinical Evidence, Evaluation and Data Scope and Definitions – Article 2 – Clinical Evidence
Clinical Evidence Art 2 (51 )
Clinical Evaluation Art 2 (44)
Clinical Data Art 2 (48)
• The clinical data and clinical evaluation report pertaining to a device • Sufficient amount and quality to allow a qualified assessment of whether the device achieves the intended clinical benefit(s) and safety, when used as intended by the manufacturer
• A systematic and planned process to continuously generate, collect, analyze and assess the clinical data pertaining to a device • To verify the safety and performance, including clinical benefit , of the device when used as intended by the manufacturer
• Clinical investigation on the device concerned • Clinical investigation reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated • Peer reviewed scientific literature on other clinical experience of either the device in question or a similar device for which equivalence can be demonstrated • Data from the manufacturer‘s
post- market surveillance system, in particular post market clinical follow- up
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Post-Market Clinical Follow up – What to look for?
Quantification of Residual Risks
Usability
Unanswered Questions
PMCF (Yes/No)
Medium- and Long-Term Safety
Side-effects and contraindications
Medium- and Long-Term Performance
Rare Complications
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Post-Market Clinical Follow up – Methods
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Post-Market Clinical Follow up - Methods
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Post-Market Clinical Follow up - Methods
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Post-Market Clinical Follow up - Methods
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Post-Market Clinical Follow up Guidances?
Reference
Title
Year
MDCG 2020-8
Guidance on PMCF evaluation report template
2020
MDCG 2020-7
Guidance on PMCF plan template
2020
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Article 86 – Periodic Safety Update Report (PSUR)
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PMS Requirements For Economic Operators (EO)
Verify full compliance with MDR requirements
Legal Manufacturer
End User
Distributor
Importer
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PMS Requirements For Economic Operators
Verify full compliance with MDR requirements
Legal Manufacturer
End User
Distributor
Importer
Post market surveillance and vigilance
Competent Authorities
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PMS Requirements For Economic Operators
Verify full compliance with MDR requirements
Legal Manufacturer
End User
Distributor
Importer
Post market surveillance and vigilance
Competent Authorities
Regulatory compliance of device
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PMS Requirements for Economic Operators (EO)
MDR Requirement
Importer (Art 13)
Distributor (Art 14)
EU- REP (Art 11)
Verify compliance to MDR Requirements
X
X
X
Keep copies of tech file, DoC and Certificates
X
X
Support request for commercial device samples or access to commercial device
X
Place name + address on Device, packaging or IFU
X
Verify device is registered (Art 29)
X
X
Ensure compliance with storage /shipping requirements
X
X
X
X
X
Forward complaints/suspected incident reports to EU REP & manufacturer
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PMS Requirements for Economic Operators (EO)
MDR requirement
Importer (Art 13)
Distributor (Art 14)
EU- REP (Art 11)
Alert other EO/CA to non-conforming product
X
X
Keep Register of Complaints, Non-conforming product, recalls and withdrawals
X
Full cooperation with CA and Manufacturers
X
X
X
Meet traceability requirements
X
Verify UDI assignment where applicable
X
X
Shares liability for defective devices with legal manufacturer
X
Legend: CA = Competent Authority DoC = Declaration of Conformity EU-REP = European Authorized Representative EO = Economic Operator UDI = Unique Device Identifier
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Are there any further Guidance Documents?
A screenshot of a computer
Description automatically generated
Until the end of 2022, things were pretty
quiet regarding MDCG guidance
documents on post-market surveillance
(PMS).
However, as of today, the MDCG has
actively published guidances to assist
medical device manufacturers
implementing a compliant Post-Market
Surveillance Process.
Source: https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en#sec16
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Is there any other Guidance? ISO/TR 20416:2020
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Is there any other Guidance? ISO/TR 20416:2020
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Is there any other Guidance? ISO/TR 20416:2020
The intent of this guidance
document is to provide guidance
to manufacturers who are planning and executing their post-market surveillance activities” and should be read in conjunction with ISO 13485 and
ISO 14971. (ISO/ TR 20416:2020)
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Summary and Learning Outcome
MDR PMS Requirements are applicable to all medical devices from May 26, 2021 on!
MDR PMS Requirements are more explicit and prescriptive as compared to the former Directives, but also give more details about what to implement and how to document and report when and with what content.
Post- Market Surveillance is a continuous Life-Cycle Approach.
PMS is a data driven approach and requires structure and resources for good data.
MDR PMS has a significant impact on Risk Management, Clinical Evaluation and Technical Documentation for maintaining the CE-Marking .
New and different PMS Technical Documentation and Reporting Requirements!
Greater involvement of Economic Operators , Notified Bodies and Competent Authorities
However, there are good Guidance documents available to assist implementing a robust EU-MDR PMS System.
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References
• REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• MDCG 2022-21 Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 (MDR)
• MDCG 2021-25 Regulation (EU) 2017/745 - application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC
• MDCG 2020-8 Guidance on PMCF evaluation report template
• MDCG 2020-7 Guidance on PMCF plan template
• MDCG 2020-3 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD
• ISO/TR 20416:2020 Medical devices — Post-market surveillance for manufacturers
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More References
• EUROPEAN COMMISSION – DG SANTE Management of Legacy Devices MDR EUDAMED Ver. 1.2
• BVMed # MDReady Bottleneck Grace Period MDR
• BVMed # MDReady Certificates are not issued on time
• Team-NB-PositionPaper- ExpiringCertificates-20201215
Related Standards and Guidances
• ISO 13485:2016 Medical devices – QM systems - Requirements for regulatory purposes
• ISO 14971:2019 – Risk Management for Medical Devices
• ISO 24971:2020 - Medical Device – Guidance on the Application of ISO 14971
• ISO TR 20416 - Medical devices - Post-market surveillance for manufacturers
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Thank You!
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Unique Device Identification & Traceability in Healthcare
Jenny Young-Gough
The Organisation for Professionals in Regulatory Affairs The Organisation for
Professionals i Regulatory Affairs
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Learning Outcomes
• Unique Device Identification (UDI)
• Understanding what UDI is and how it is applied?
• Basic UDI-DI
Databases
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• Regulatory Databases / GDSN
• US FDA GUDID
• EUDAMED
Traceability
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• How UDI enhances supply chain traceability through to use on a patient.
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Unique Device Identification
• Unique Device Identification – Current & Developing Legislation
• US/China/Egypt/Hong Kong/South Korea/Saudi Arabia/Taiwan – already in place • EU – from 2021 – 2025 depending on risk Class • Brazil – 2020 for high risk devices • ANZ – in line with EU • UK, Japan, India, Singapore, Canada and Switzerland all tbc.
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Unique Device Identification (UDI) – Why UDI?
• Need to improve traceability in the Healthcare Supply Chain
• UDI is an enabler – McKinsey Report (October 2012) highlighted the patient safety benefits and cost savings from adopting a single global supply chain standard in healthcare.
• Could save 22,000 – 43,000 lives
• Could avert 0.7 million to 1.4 million patient disabilities
• Cost savings of $40 - $100 billion globally
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Unique Device Identification (UDI) – Why UDI?
• GS1 was implemented through certain departments within six hospitals.
• GS1 barcodes were applied to:
Patient wrist bands
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Equipment
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Locations
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Staff badges
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Results
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• 140,000 hours released for clinical staff
• £5,000,000 inventory savings
• £9,000,000 non-recurrent inventory reductions
• Pharmacy error rates reduced by 76% (one hospital)
• Product recall time reduced from 8.33 days to 35 minutes (saving £84,500 per annum) (one hospital)
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Unique Device Identification (UDI) – What is it?
• UDI is a two-part system used to mark and identify a Medical Device at any given point in time within the Healthcare supply chain. • The first part of the system is the actual physical UDI which is made up of two parts: • A UDI-DI (Device Identifier) – this is a unique alphanumeric code allocated to a medical device at each packaging level. • A UDI-PI (Production Identifier) this will be the control method used in manufacturing: • Expiry Date or Date of Manufacture / Lot/batch number / Serial Number • DI + PI = UDI • The UDI is printed on the packaging of the product in both human and machine (barcode) formats.
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Unique Device Identification (UDI) – What is it?
• The Unique Numbers can be obtained from one of four different designated Standards Organisations:
• GS1
• HIBCC (Health Industry Communications Council)
• ICCBBA (International Council for Commonality in Blood Banking Association)
• IFA GmbH (Informationsstelle für Arzneispezialitäten) (EU only)
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Unique Device Identification (UDI) – What is it?
GS1 128
GS1 2D DataMatrix
(01) 0768455123456
2026-11-01
(10) ABC123
http://www.gs1.org/healthcare/udi
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Allocation of UDI-DI (GTINs) / Hierarchy • UDI-DIs are allocated to each product at each packaging level. • New UDI-DIs should be allocated whenever a significant change takes place to a product • At a minimum, a new UDI-DI is required whenever there is a change that could lead to misidentification of the medical device and/or ambiguity in its traceability.
Unit of use
Market Unit/Shelf Box
Inner
Shipper
Pallet
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UDI – Hierarchy – Procedure Packs
Unique Device Identifier (UDI) comprises of two parts: A Device Identifier (UDI-DI) – this is a fixed unique number which identifies the manufacturer and product A Production Identifier (UDI-PI) – eg, expiry date & batch number which would identify the specific production batch of product
2 Products packaged into a kit/system which then becomes a product in its own right. • This bag has its own UDI. • The DI would be issued by the manufacturer of this specific product. • The PI for this product would be the batch number allocated by the manufacturer and the expiry date of the shortest shelf life of the products contained within the bag. • The UDI information of each component within the bag should be recorded in the ERP system of the manufacturer against The Batch number for these products
3 10 kits put into a box • This box has its own UDI
1 Assortment of products All have own UDI
• The DI would be unique to this specific packaging level of this specific product and would be issued by the manufacturer of this specific product. • The PI would be the same as is on the bags.
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Reasons for allocating a new GTIN
There are a number of requirements for raising a new UDI-DI (GTIN) based upon the requirements from:
1. GS1 (Or chosen Industry Standards Organisation) - GS1 Healthcare GTIN Allocation Rules 2. IMDRF UDI System Application Guide (21 March 2019) 3. US FDA Final UDI Ruling 4. EU MDR (EU) 2017/745 (including EUDAMED Triggers)
At a minimum, a new UDI-DI is required whenever there is a change that could lead to misidentification of the medical device and/or ambiguity in its traceability.
GS1 GTIN Assignment in Healthcare – considerations for raising a new GTIN.
• Product Contained in Package: Is a Stakeholder (e.g. care providers, consumers, patients, regulatory authority and/or trading partner) expected to distinguish the changed or new product from the previous/current product? • Label/Package: Is there a regulatory or liability to disclose a change to the consumer and/or trading partner? • Label/Package: Is there a substantial change impacting the supply chain (e.g. how the trade item is shipped, stored, received, or handled in the clinical setting)?
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Reasons for allocating a new GTIN
Listed in this document are all of the reasons listed that would trigger a new UDI. This list has been consolidated to include triggers from all of the reference documents listed above.
1. A new Basic UDI-DI has been issued (new Risk Class/Intended Purpose/Essential design or manufacturing characteristics) 2. Brand Name 3. Device version or model (updates that would make the product look or behave differently to the end user or require re-registration) 4. Clinical Size (including Volume, Length, Gauge, Diameter) 5. Labelled as single use 6. Packaged sterile 7. Need for sterilization before use 8. Quantity of devices provided in a package 9. Critical warnings or contraindications: e.g. containing latex or Bis (2-ethylhexyl) phthalate (DEHP) 10. New packaging configurations 11. Declared formulation or functionality (fit form or function) 12. Declared net content 13. Dimensional or gross weight change of 20% or more 14. Add or remove certification mark 15. Pre-defined assortment (eg Procedure pack a change to one or more components (including the supplier)) 16. New language version (not required for additional languages) 17. Major changes to software that require a new Version number ie moving to version 3.0 from 2.2 (such as new or modified algorithms, database structures, architecture, new user interfaces or new channels of interoperability). 18. UDI-DI Issuing Agency 19. New Catalogue or model number 20. Addition or removal of Direct Marking 21. Type of PI (Production Information) included in the UDI barcode
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Unique Device Identification (UDI) – Datapools
• The second part of the system is data which is shared in two specific areas:
• Regulators – these will be used to monitor all safety related issues and product licencing:
adverse events
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post market surveillance
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clinical trials
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etc.
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• Supply Chain / Healthcare Institutions – these are used for practical day to day transactions.
stock control
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stock location
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• automation of order to cash process
event costing by patient
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cost per episode
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• product recalls / stock withdrawal
• most importantly traceability of stock through to the patient which
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UDI – Data – Core Data Elements (IMDRF)
1. For every device packaging level – the following shall be provided in a related way (for entire packaging hierarchy): ● UDI-DI (UDI type, e.g. GS1 GTIN, HIBC-LIC, ISBT-128 PPIC), ● Quantity per package configuration: (e.g., each, 10 each, 5 shelf packs), ● Additional device identifier(s) (if applicable) e.g. GS1, HIBC, or ISBT 128; 2. The Unit of Use UDI-DI code; 3. Manufacturer’s name (if applicable); 4. Manufacturer’s address (if applicable); 5. Manufacturer's customer service contact information (country/region specific, could be multiple);(If applicable) 6. Authorized Representative's name (regional representatives responsible for the medical device) (country/region specific, could be multiple) (if required by the local/regional regulatory authority) 7. Authorized Representative's contact information (country specific, could be multiple); 8. Global Medical Device Nomenclature (GMDN) preferred code/term (valid at
15. Additional product Description (optional) – Additional clinically relevant information, e.g. radio-opaque; 16. Storage conditions, as labelled or in the IFU (if applicable) – to include temperature range, needs to be refrigerated, relative humidity range, pressure range, avoid direct sunlight; 17. Handling conditions (if different than storage conditions), on the label or in the IFU (if applicable) – to include temperature range, needs to be refrigerated, relative humidity range, pressure range, avoid direct sunlight; 18. Labelled as single use? (Yes/No); 19. Packaged sterile? (Yes/No); 20. Need for sterilization before use? (Yes/No) – if yes, then the method of sterilization should be indicated ; 21. Restricted number of reuses (if applicable); 22. License and/or marketing authorization or registration number (if required by the relevant regulatory authority) 23. URL for additional information, e.g. electronic IFU (optional); 24. Critical warnings or contraindications (as labelled) – if a particular regulation requires that the label of the device contains a critical warning or contraindication associated with the use of the device, eg: Labelled as containing latex? (Yes/No), Labelled as containing DEHP? (Yes/No) Labelled as MRI compatible? (Yes/No).] 25. Date of discontinuance (referring to devices no longer placed on the market).
the time of the UDI submission); 9. Brand Name (if applicable); 10. SaMD version; 11. Device model or version; 12. Reference and/or catalogue number (if applicable);
13. How the device is controlled: serial, lot/batch number, and/or expiration date (or manufacturing date) or software version or software released date or ISBT-128 – check boxes (if applicable); 14. Clinical Size (including Volume, Length, Gauge, Diameter) (if applicable) (e.g. 8F catheter);
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EUDAMED & Databases
• Regulators such as the FDAs GUDID and the EU Commissions EUDAMED which are more focussed on the Regulatory side of product information • Most Databases such as the US FDA GUDID is a standalone UDI module storing the information listed in the previous slides against UDI-DI numbers. • EUDAMED is a much larger database with 7 different modules: • Actor Registrations / UDI (Product Registrations) / Certificates / Clinical / Vigilance / Market Surveillance / Public
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EUDAMED
• Available Voluntarily Now 1. Actor Module – becomes Mandatory in January 2026 – Actor Registrations – Manufacturers, Authorised Representatives, Importers. SRN numbers issued when registered. 2. Device (UDI) Module – becomes Mandatory in January 2026 – Device Registrations – Devices registered under Basic UDIs and UDIs. 3. Certificate Module – becomes Mandatory in January 2026 – Certificate Registrations – Notified Bodies register Certificates and relevant statuses. • Still in Development 4. Post Market Surveillance Module – becomes Mandatory in January 2026 – Post Market surveillance Reporting. 5. Vigilance Module – becomes Mandatory in July 2026 – Vigilance Reporting. 6. Clinical Module – TBC (2027) – Clinical Investigations / Performance Studies – Manufacturers. 7. Public Module – data becomes available as and when modules go live. – Non-confidential data from all modules. – Data to be included in public module as and when modules go live. Voluntary modules being used are already visible.
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