Module 16 2022

Post Market Surveillance and Vigilance for Medical Devices

Location: TOPRA Office, 6 th Floor, 3 Harbour Exchange, London E14 9GE and online

Module Leader : Theresa Jeary

Date: Monday 5 th September 2022

Time

Activity

Speaker

13:00

Registration and Welcome and Introduction

Kay Platt

13.30 – 15.00

Lecture 1: Where are we with the MDR?

Stephan Buttron

PMS European Requirements

Buttron Consulting

New Legislation Vs Current

remote

New Legislation Vs Current Refreshment Break

15.00 – 15.30

Lecture 2: Unique Device Identification & Traceability in healthcare • UDI • Eudamed and Databases • Traceability

15:30 – 17:00

Jenny Young-Gough

JYG Consulting

Module requirements and availability

Post Market Surveillance and Vigilance for Medical Devices

Date : Tuesday 6 th September 2022

Time

Activity

Speaker

Lecture 3: The Role and Responsibility of Notified Bodies in Vigilance and Post Market Surveillance

09:00 – 10:00

Theresa Jeary

BSI

10.00 – 10.30

Refreshment Break

10.30 – 11.30

Andreas Huber

Novartis

Lecture 4: Risk Management/Risk Assessment

Remote

11.30 – 12.30

Lunch

John Deavin

Confirmed

12.30 – 13.30

Case Study

Lecture 5: Post Market Surveillance and Corrective and Preventive Actions:

Theresa Jeary

13.30 – 14.30

BSI

14.30 - 15.00

Refreshment Break

Adrian Keene

Lecture 6: Periodic Safety Update Report • SSCP

Namsa

15.00 - 16.00

Remote

Guidance 2.12 1 rev 8

Lecture 7: Post Market Clinical Follow Up • Plan • Implementation Overview • PMCF studies

Adrian Keene

Namsa

16.00 - 17.30

Remote

PMCF evaluation report

Post Market Surveillance and Vigilance for Medical Devices

Date: Wednesday 7 th September 2022

Time

Activity

Speaker

09.30 – 10.30

Lecture 8: Vigilance Reporting – an Agency perspective

MHRA

Common issues and pitfalls to avoid Reporting of serious incidents and field safety corrective actions

• •

10.30 – 11.00

Refreshment Break

Transparency schemes

•

11.00 – 12.30

Grant Castle

Borderline issues on MDs Lecture 9: Post Market Surveillance - Legal Considerations • Criminal and administrative liabilities • Considerations for listed companies

Covington & Burling LLP

Public Relations

12:30 – 13:30

Lunch

13.30 – 15.00

Lecture 10: Field Safety Corrective Actions - Legal Considerations • Field safety corrective actions • Safeguard measures

Grant Castle

Covington & Burling LLP

Product liability

15.00 – 15.30

Close of Module

9/2/2022

Legacy Devices and MDR Article 120 Transitional Provisions

Stephan Buttron, Buttron Consulting Berlin, Germany

The Organisation for Professionals in Regulatory Affairs The Organisation for

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Agenda

• MDR Regulatory Framework, Requirements and Key Changes • Article 120 Transitional Provisions • MDR Transition Timelines • Important Definitions • Overview of MDR regulations for legacy devices • Eudamed and legacy devices Registration • Bottlenecks and Business Risks • Interactive Case Study • Summary and Learning Outcome • Q&A

TOPICS

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• MDR Regulatory Framework, Requirements and Key Changes

The EU MDR is the European Union Medical Device Regulation 2017/745 that was published in May 2017 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 devices that are produced in, or supplied to, member countries of the European Union.

This new regulatory framework is intended to be a regulatory framework for medical devices that can sustainably ensure health & safety while still encouraging innovation.

TOPICS

https://advisera.com/13485academy/what-is-eu-mdr/

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MDR Regulatory Requirements and Key Changes

D=Directive: Legal Act that sets out conformity assessment rules and must be transposed into EU Member state national law to be effective.

R=Regulation : Mandatory Jurisdiction that is directly applicable and enforceable in all EU Member States .

1 Ratified Version April 05 th , 2017

Source: https://medicaldevicehq.com/articles/new-in-the-2017-745-mdr/

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MDR Regulatory Requirements and Key Changes

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2022 © TÜV SÜD AG/MKG/MHS/41.0/en/SG

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MDR Regulatory Requirements and Key Changes

TOPICS

2022 © TÜV SÜD AG/MKG/MHS/41.0/en/SG

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MDR Regulatory Requirements and Key Changes

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2022 © TÜV SÜD AG/MKG/MHS/41.0/en/SG

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MDR Regulatory Requirements and Key Changes

TOPICS

2022 © TÜV SÜD AG/MKG/MHS/41.0/en/SG

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MDR Regulatory Requirements and Key Changes

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2022 © TÜV SÜD AG/MKG/MHS/41.0/en/SG

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MDR Regulatory Requirements and Key Changes

TOPICS

2022 © TÜV SÜD AG/MKG/MHS/41.0/en/SG

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MDR Regulatory Requirements and Key Changes

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2022 © TÜV SÜD AG/MKG/MHS/41.0/en/SG

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MDR Regulatory Requirements and Key Changes

TOPICS

2022 © TÜV SÜD AG/MKG/MHS/41.0/en/SG

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MDR Regulatory Requirements and Key Changes

TOPICS

2022 © TÜV SÜD AG/MKG/MHS/41.0/en/SG

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Article 120 Transitional Provisions Paragraph 2

Certificates issued by notified bodies in accordance with Directives prior to 25 May 2017 shall remain valid until the end of the period indicated on the certificate , except for certificates issued in accordance with Annex 4 to Directive 90/385/EEC or Annex IV to Directive 93/42/EEC which shall become void at the latest on 27 May 2022. Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/ EEC from 25 May 2017 shall remain valid until the end of the period indicated on the certificate , which shall not exceed five years from its issuance. They shall, however, become void at the latest on 27 May 2024. and

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Article 120 Transitional Provisions Paragraph 3

By way of derogation from Article 5 of this Regulation,

(1) a device with a certificate that was issued in accordance with (2) which is valid by virtue of paragraph 2 of this Article

or

and

may only be placed on the market or put into service provided that from the date of application of this Regulation it continues to comply with either of those Directives , and provided there are no significant changes in the design and intended purpose . However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives.

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Article 120 Transitional Provisions Paragraph 3

Devices lawfully placed on the market pursuant to Directives prior to 26 May 2021 , and devices placed on the market from 26 May 2021 by virtue of a certificate as referred to in paragraph 2 of this Article , may continue to be made available on the market or put into service until 27 May 2025 and

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MDR Transition Timelines

TOPICS

Source: Modified infographic from the EU Commission

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MDR Transition Timelines

TOPICS

Source: Modified infographic from the EU Commission

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MDR Timelines

TOPICS

Source: Modified infographic from the EU Commission

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Article 120 Transitional Provision Timelines

26 May 2021 Date of Application

25 May 2017 Entry into Force

27 May 2024 MDD/AIMD Sunset

Transition period 3 years

27 May 2025 Sell-Off Sunset

MDD/AIMDD «grace period» 3 years

MDD/AIMDD Certificates

Annex IV/ 6 certificates void

No more « placing on the market » of devices covered by MDD/AIMD certificates

all MDD/AIMD certificates void

MDR Certificates

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Article 120 Transitional Provision Timelines

PMS, market surveillance, vigilance, registration of economic operators and of devices according to MDR

26 May 2021 Date of Application

25 May 2017 Entry into Force

27 May 2024 MDD/AIMMD Sunset

Transition period 3 years

27 May 2025 Sell-Off Sunset

MDD/AIMDD «grace period» 3 years

MDD/AIMDD Certificates

Annex IV/ 6 certificates void

No more « placing on the market » of devices covered by MDD/AIMD certificates

all MDD/AIMD certificates void

MDR Certificates

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Important Definitions – Significant Changes Following Article 120 significant changes are those device modifications that are not allowed in the transition period for devices covered by certificates issued under the MDD/AIMDD.

- Significant Design Changes - Intended Use/Indications for Use

MDCG 2020-03 , that 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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Important Definitions – Placing on the Market 2.3 A product is placed on the market when it is made available for the first time on the Union market . According to Union harmonisation legislation, each individual product can only be placed once on the Union market. Products made available on the market must comply with the applicable Union harmonisation legislation at the moment of placing on the market.

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Important Definitions – Making available

2.2. Making available on the market

 A product is made available on the market when supplied for distribution, consumption or use on the Union market in the course of a commercial activity , whether in return for payment or free of charge.

 The concept of making available refers to each individual product .

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Important Definitions – Special Considerations for SaMD and Apps

2.4. Making available and placing on the market in case of distance and online sales

Products offered for sale online or through other means of distance sales are deemed to be made available on the Union market if the offer is targeted at end users in the Union (58). The legal consequence is that, if the offer is targeted at end users in the Union, products offered for sale online or through other means of distance sales need to comply with all applicable EU rules and can be subject to checks by market surveillance authorities pursuant to Regulation (EU) 2019/1020. If products are sold online, it is required that the CE marking and any required warnings according to applicable legislation are indicated in that website and visible before the end user is carrying out the purchase.

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Important Definitions – Special Considerations for SaMD and Apps 2.4. Making available and placing on the market in case of distance and online sales Online or distance selling may be a specific manner of making products available but it does not necessarily constitute the first making available of the product on the Union market (i.e. the placing on the market). The actual placing on the market of these products may differ for each individual product, depending on the specific distribution chain, for example: The distance sale or online offer may refer to products that have already been placed on the Union market. This is the case where the EU manufacturer or an importer has already placed them on the Union market before they were offered for sale online or through other means of distance selling. Some products offered online or through other means of distance selling to end users in the Union are transferred first to fulfilment service providers located in the EU to guarantee their swift delivery to EU end users. Accordingly, products stored by such fulfilment service providers and released for free circulation are considered to have been supplied for distribution, consumption or use on the EU market and thus placed on the EU market. When an online operator uses a fulfilment service provider in this manner, by shipping the products to the fulfilment house in the EU, the products are in the distribution phase of the supply chain (61). These products are considered placed on the market at the time they are released for free circulation. Some products outside the EU can be bought directly by end-users in the EU online or through other means of distance sales. Although these products are deemed to be made available in the Union prior to any transaction for the purposes of checks by market surveillance authorities pursuant to Regulation (EU) 2019/1020, they are placed on the market at the moment an order by an end user has been placed and confirmed for a specific product already manufactured and subject of the transaction, and ready to be shipped.

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Important Definitions – Special Considerations for SaMD and Apps Software Software is today essential for the functioning of products. Under the medical device and in vitro medical devices legislation, software in its own right presenting certain features is considered as a medical device or an in vitro diagnostic medical device (41). Certain pieces of Union harmonisation legislation refer explicitly to the software integrated in the product (42). Software updates or repairs could be assimilated to maintenance operations provided that they do not modify a product already placed on the market in such a way that compliance with the applicable requirements may be affected . As is the case for physical repairs or modifications, a product should be considered as substantially modified by a software change where: i) the software update modifies the original intended functions, type or performance of the product and this was not foreseen in the initial risk assessment; ii) the nature of the hazard has changed or the level of risk has increased because of the software update; and iii) iii) the product is made available (or put into service where this is covered by the specific Union harmonisation legislation).

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Important Definitions – Legacy vs. Old Devices What are Legacy Devices?

The missing definition is provided by the guidance document 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 ): Legacy devices are devices placed on the market according to Article 120(3) of the MDR after the application date of the MDR and under certain conditions until May 26, 2024.  (1) Class I devices according to Directive 93/42/EEC (MDD) for which a declaration of conformity was issued before May 26, 2021 and for which the conformity assessment procedure according to the MDR requires the involvement of a notified body;  (2) Medical Devices having a valid EC certificate issued before May 26, 2021 in accordance with Directive 90/385/EEC (AIMDD) or the MDD. The terminology of ‘legacy devices’ and ‘old devices’ is in line with existing MDCG guidance such as MDCG-2021-13 rev.1

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Important Definitions – Legacy vs. Old Devices What are Old Devices?

The missing definition is provided by the guidance document 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 ): ‘ Old’ devices are those devices that were placed on the market: - before 26 May 2021 in accordance with the AIMDD or the MDD or - in accordance with the applicable rules before the Directives had entered into force . The MDCG task-force considers that MDR requirements are in principle not applicable to ‘old’ devices . However, Articles 93 to 100 MDR, which lay down rights and obligations of competent authorities with regard to market surveillance activities, apply also to ‘old’ devices.

The terminology of ‘legacy devices’ and ‘old devices’ is in line with existing MDCG guidance such as MDCG-2021-13 rev.1

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Important Definitions – Sell-Off Provision Article 120 Transitional provisions (4) for Legacy and Old Devices

Devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to 26 May 2021 , and devices placed on the market from 26 May 2021 pursuant to paragraph 3 of this Article , may continue to be made available on the market or put into service until 26 May 2025.

PMS, Market Surveillance, Vigilance, Registration of economic operators and of devices according to MDR

26 May 2021 Date of Application

27 May 2024

No more « placing on the market » of devices covered by MDD/AIMD certificates 27 May 2025

Only if no significant changes in design and intended purpose.

MDD/AIMDD «grace period » 3 years 27 May 2022

Annex IV/ 6 certificates void

all MDD/AIMD certificates void

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Post-Market Surveillance – General Policy

Section I – POST-MARKET SURVEILLANCE Article 83 – Post-market surveillance system of the manufacturer 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

Design, Manufacture

Shelf-Life

Use Life

Placement on Market

Point of first use

Time from data manufacture to the claimed use-by date

Number or period of subsequent uses

Disposal or Decommission

Pre-market phase

Conception

Life-cycle ISO 14971: All phases in the life of a medical device, from the initial conception to final decommissioning and disposal

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Overview of MDR Regulations for legacy devices

During the MDR transitional period, legacy 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 ‘legacy devices’

Art. 10(10), (12)-(15) - General obligations of manufacturers

YES ( nota bene : ‘conformity with the requirements of this Regulation’ shall mean for ‘legacy devices’ conformity with the MDD or AIMDD and the additional requirements in accordance with Article 120(3) MDR) YES ( nota bene : ‘conformity with the requirements of this Regulation’ shall mean for ‘legacy devices’ conformity with the MDD or AIMDD and the additional requirements in accordance with Article 120(3) MDR)

Art. 11(3)(c)-(g) - Authorised representative

Art. 11(7) - Authorised representative

YES

Art. 13(2), 2nd subparagraph, (4), (6)-(8),(10) - General obligations of importers

YES ( nota bene : ‘conformity with the requirements of this Regulation’ shall mean for ‘legacy devices’ conformity with the MDD or AIMDD and the additional requirements in accordance with Article 120(3) MDR)

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Overview of MDR regulations for legacy devices

MDR requirement

Application to ‘legacy devices’

Art. 14(2), last subparagraph, (4)-(6) - General obligations of distributors Art. 15 - Person responsible for regulatory compliance

YES ( nota bene : ‘conformity with the requirements of this Regulation’ shall mean for ‘legacy devices’ conformity with the MDD or AIMDD and the additional requirements in accordance with Article 120(3) MDR)

NO

Art. 16(3) and (4)

NO

Art. 18 - Implant Card

NO (without prejudice to national rules on implant cards applicable to ‘legacy devices’)

Art. 22 - Systems and procedure packs Art. 25 -Identification within the supply chain

YES for system or procedure packs combining ‘legacy devices’ and MDR devices

NO (without prejudice to traceability requirements in the supply chain applicable to ‘legacy devices’ in accordance with other rules such as on market surveillance of goods or the General Product Safety Directive)

Art. 27 Unique Device Identification system

(See in this respect also MDCG 2019-5 on registration of legacy devices in Eudamed)

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Overview of MDR regulations for legacy devices

MDR Requirements

Application to ‘legacy devices’

Art. 29 – Registration of devices

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) MDR10 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) MDR11

Art. 31 – Registration of economic operators Art. 32 - Summary of safety and clinical performance Art. 83, 84 – PMS system and PMS plan

NO

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) 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) 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)

Art. 85 – PMS report (class I devices)

Art. 86 – PSUR (class IIa, IIb and III devices)

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Overview of MDR regulations for legacy devices

MDR Requirements

Application to ‘legacy devices’

Art. 87 – reporting of serious incidents Art. 88 – trend reporting

YES

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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Overview of MDR Post-Market Regulations for legacy devices

Source: https://www.metecon.de/de/news/pms-und-pmcf-zur-gewinnung-klinischer-daten-bis-2020/u/1009/

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UDI Requirements (Article 27 and Annex VI)

UDI will be first time applicable in European Union with MDR : • A new database under the European regulation shall be installed • The UDI and product related information need to be uploaded into that database before placing a product onto the European market • Traceability is based only on UDI information in Eudamed database and transferred to Economic operators (Distributor, Authorized Rep, Importer etc.) • Details of product related information necessary for the upload are described in Annex VI, Part A and B • The UDI must be assigned by the manufacturer only!

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Eudamed and legacy devices Registration Do the legacy devices have the same identifiers as Regulation devices?

Legacy devices will not have a previously assigned Basic UDI-DI, they will be assigned a “EUDAMED-DI” in EUDAMED to ensure consistent handling of device registration in EUDAMED.

The EUDAMED ID concept?

The EUDAMED ID corresponds to the UDI-DI. The EUDAMED ID is a virtual Device Identifier. It exists in order to keep the structure and format homogeneous for the registration of Devices in EUDAMED. It is not applied on labels.

How is it issued?

In case the legacy device already has an assigned a UDI-DI, the EUDAMED ID is entirely generated by EUDAMED. In case the legacy device has not been assigned a UDI-DI, the DI part of the code can be partly assigned by the manufacturer. EUDAMED is considered as the “issuing entity” of the EUDAMED ID.

Source: https://eu-udi.zendesk.com/hc/en-150/articles/360019389377-What-about-Legacy-devices

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Eudamed and legacy devices Registration

When do manufacturers have to register legacy devices?

Legacy devices shall be registered in EUDAMED in two cases:

• a post-market surveillance and/or a vigilance report occurs; • by the end of the transition period applicable for device registration, if no equivalent MDR or IVDR device is registered in EUDAMED. Guidance MDCG 2019-5 identifies the mandatory registration of legacy devices when a serious incident occurs or when there is a field safety corrective action to apply on them, requiring their registration as soon as possible and at least before a follow-up or final vigilance report is submitted.

Source: https://eu-udi.zendesk.com/hc/en-150/articles/360019389377-What-about-Legacy-devices

9/2/2022

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Eudamed and legacy devices Registration

Source: https://eu-udi.zendesk.com/hc/en-150/articles/360019389377-What-about-Legacy-devices

9/2/2022

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Major Obstacles and Business Risks

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Major Obstacles and Business Risks

• The number and capacities of the Notified Bodies under the MDR are still far too small to transfer all existing devices to the MDR on time. Currently there are only 30 Notified Bodies. Many manufacturers – for example of surgical instruments or software – have to conclude new contracts with Notified Bodies. • The transition period for the validity of the old certificates ("grace period") until May 2024 and the sell-off period until May 2025 were not adjusted when the start of validity was postponed – despite the effects of the Corona pandemic. The expected shortages therefore remain and have even increased.

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Major Obstacles and Business Risks

• The approximately 20,000 legacy certificates will thus not all to be transferred to the MDR by the end of the transition period in May 2024.

• Currently, only about 1,500 MDR certificates have been issued. Multiple times that amount is pending to the Notified Bodies as an application .

• It is foreseeable that the situation will come to a dramatic head in 2024 .

• Many medical devices will not make the transition into the MDR on time. There is a threat of supply bottlenecks, innovation bottlenecks and distortion of competition.

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Major Obstacles and Business Risks

Source: https://www.team-nb.org/wp-content/uploads/2020/12/Team-NB-PositionPaper-ExpiringCertificates-20201215.pdf

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Major Obstacles and Business Risks

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Major Obstacles and Business Risks

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Interactive Case Study – Mobile Medical App

Device Description and Regulatory Status:

The Mobile Medical App is intended to detect, record, store and transfer electrocardiogram (ECG) rhythms from external contact sensors for vital sign monitoring. The Mobile Medical App displays ECG rhythms and output of ECG analysis on iOS and Android Smartphones.

• The medical SmartPhone App is a Class IIa SaMD • The from external contact sensors for vital sign monitoring are Class IIa devices. • The Medical SmartPhone App is offered for sale from Apples and Androids App Stores • The vital signs monitoring sensors are offered for sale from Amazon. • Current MDD:M5 CE-Mark Certificate expires in March 2023 • Involved EU Notified Body is not able to start an MDR Conformity Assessment in acc. with Annex IX prior November 2022 .

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Interactive Case Study – Mobile Medical App

• The medical SmartPhone App is a Class IIa SaMD • The from external contact sensors for vital sign monitoring are Class IIa devices. • The Medical SmartPhone App is offered from Apples and Androids App Stores

• The vital signs monitoring sensors are offered from Amazon. • Current MDD:M5 CE-Mark Certificate expires in March 2023 • Involved EU Notified Body is not able to start an MDR Conformity Assessment in acc. with Annex IX prior November 2022 .

Questions:

1) What should the legal manufacturer consider to commercially distribute the SaMD SmartPhone App and the vital signs sensors after 26 May 2021 in EU and EFTA States?

The legal manufacturer wants to continue commercial distribution of the SaMD SmartPhone App and the vital signs sensors post MDD:M5 CE- Mark certification expiry date.

2) What is a MDR compliant regulatory strategy ? 3) What MDR Regulatory Requirements do apply ? 4) What are the business risks and implications for the regulatory strategy?

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Source: https://eu-udi.zendesk.com/hc/en-150/articles/360019389377-What-about-Legacy-devices-

MDR Legacy Device - Key Impacts

 The transition period covers requirements for Legacy Device and Old Devices

 New and different MDR requirements apply for Legacy Devices

 Implement all applicable QMS regulatory Requirements for Legacy Devices as set forth in MDCG

 Anticipate MDD Certificate Expiration prior having a new MDR Certification issued by NB

 Anticipate long or very long lead times for MDR Certification with NB

 Consider Contingency Stock for continued EU Distribution

 Be patient and alert for new MDCG publications

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Summary and Learning Outcome

 Transitional Provisions are challenging for Legacy Devices.  Carefully consider proposed design changes for Legacy Devices  Significantly increased PMS Data Collection, Analysis and Reporting Requirements  Uncertainties on NB MDR Certification Timelines and Certification issues  Find a committed MDR Notified Body and carefully plan for contingencies

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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 • The ‘Blue Guide’ on the implementation of EU product rules 2022 (2022/C 247/01) • 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 • 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 2021-13 rev.1 Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorized representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR

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References

• What about Legacy devices? EU UDI Help Desk https://eu-udi.zendesk.com/hc/en-150/articles/360019389377 What-about-Legacy-devices- • EUROPEAN COMMISSION – DG SANTE Management of Legacy Devices MDR EUDAMED Ver. 1.2 • BSi Compliance navigator EUDAMED and legacy devices September 2021 by Mary Gray

• BVMed #MDReady Bottleneck Grace Period MDR • BVMed #MDReady Certificates are not issued on time • Team-NB-PositionPaper-ExpiringCertificates-20201215

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05/09/2022

Unique Device Identification & Traceability in Healthcare

Jenny Young-Gough

The Organisation for Professionals in Regulatory Affairs The Organisation for

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Learning Outcomes

• Unique Device Identification (UDI) • Understanding what UDI is and how it is applied? • Basic UDI-DI • EUDAMED and databases • What is Eudamed and what is its purpose. • Other Databases – Regulatory / GDSN • Traceability • How UDI enhances supply chain traceability through to use on a patient. • What is the role of EUDAMED from a traceability perspective

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Unique Device Identification

• Unique Device Identification – Current & Developing Legislation • US – already in place • EU – from 2021 – 2025 depending on risk Class • China – from October 2020 • Hong Kong - 2019 – 2022 depending on risk Class • South Korea – 2019 – 2022 depending on risk Class • Saudi Arabia – 2020 • Brazil – 2020 for high risk devices • Egypt – October 2022 • ANZ – database available now as test system, live voluntarily 2023, mandatory 2024 • UK, Japan, Taiwan, India, Singapore, Canada and Switzerland all tbc.

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Unique Device Identification (UDI) – What is it?

• UDI is a two part system which can be used to identify a Medical Device at any given point in time within the Healthcare supply chain. • The first part of the system is a two part number: • 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

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Unique Device Identification (UDI) – What is it?

• The Unique Numbers can be obtained from one of four different 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?

http://www.gs1.org/healthcare/udi

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Unique Device Identification (UDI) – What is it?

• The relevant UDI-DI and PI will be printed on the product packaging at all secondary packaging levels: • Human readable format • Machine readable format – barcode • This enables electronic scanning of the product at various points within the supply chain (if scanning is not possible then the information can be keyed in)

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Unique Device Identification (UDI) – What is it?

• The second part of the UDI System is a series of databases where various data elements related to the product are stored against the UDI-DI • When the item is scanned within the supply chain this will retrieve information from the various systems relating to the product • In Healthcare the IMDRF (International Medical Device Regulators Forum) defined a list of 25 ‘Core’ data elements in 2013. Each region will add further elements if and when required.

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05/09/2022

Unique Device Identification (UDI) – What is it?

• 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; • The Unit of Use UDI-DI code; • Manufacturer’s name (if applicable); • Manufacturer’s address (if applicable); • Manufacturer's customer service contact information (country/region specific, could be multiple);(If applicable) • 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) • Authorized Representative's contact information (country specific, could be multiple); • Global Medical Device Nomenclature (GMDN) preferred code/term (valid at the time of the UDI submission); • Brand Name (if applicable); • SaMD version;

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Unique Device Identification (UDI) – What is it?

• Reference and/or catalogue number (if applicable);

• 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);

• Clinical Size (including Volume, Length, Gauge, Diameter) (if applicable) (e.g. 8F catheter);

• Additional product Description (optional) – Additional clinically relevant information, e.g. radio opaque; • 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; • 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; • Labelled as single use? (Yes/No);

Packaged sterile? (Yes/No);

•

• Need for sterilization before use? (Yes/No) – if yes, then the method of sterilization should be indicated ;

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Unique Device Identification (UDI) – What is it?

Restricted number of reuses (if applicable);

•

• License and/or marketing authorization or registration number (if required by the relevant regulatory authority)

• URL for additional information, e.g. electronic IFU (optional);

• 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).]

• Date of discontinuance (referring to devices no longer placed on the market).

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Unique Device Identification (UDI) – What is it?

• 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. • Brand Name • Device version or model • Clinical Size (including Volume, Length, Gauge, Diameter) • Labelled as single use • Packaged sterile • Need for sterilization before use • Quantity of devices provided in a package • Critical warnings or contraindications: e.g. containing latex or Bis (2-ethylhexyl) phthalate (DEHP) • New packaging configurations • Declared formulation or functionality (fit form or function) • Declared net content • Dimensional or gross weight change of 20% or more • Add or remove certification mark • Pre-defined assortment (eg Procedure pack a change to one or more components (including the supplier)) • New language version (not required for additional languages)

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Unique Device Identification (UDI) – What is it?

Basic UDI-DI • The Basic UDI-DI will be the main key into the EU Regulatory Database (EUDAMED) and the relevant documentation and is intended to connect devices with the same: • Intended purpose • Risk Class • Essential design and manufacturing characteristics • Technical File • It is independent/separate from the packaging/labelling of the device and does not appear on any trade item • Any Basic UDI-DI shall identify the devices (group) covered by that Basic UDI-DI in a unique manner • A Basic UDI-DI may have numerous UDI-DIs attached to it (but not vice versa)

•

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Unique Device Identification (UDI) – What is it?

• The Basic UDI-DI will be listed in the following documents: • Technical Documentation (provided to Notified Body in conformity assessment application) • EU Declaration of Conformity • Product Certificate – Technical Documentation assessment certificate

– EU type examination certificate – EU product verification certificate

• Certificate of Free Sale • Summary of Safety and Clinical Performance (SSCP) • Vigilance and Post-Market Surveillance Reports – Manufacturer Incident Report form (MIR)

– Periodic Safety Update Report (PSUR) – plan and report – Field Safety Corrective Action Reporting form (FSCAR form) – Periodic Summary Report form (PSR)

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Unique Device Identification (UDI) – What is it? Basic UDI-DI • Virtual (not printed on packaging) • Included in EUDAMED, Certificate, Declaration of Conformity

Product Family Eg Latex Gloves

UDI-DI & PI •

Printed on single pack and tertiary packaging levels

Product Eg Latex Surgical Glove size 6.5

Product Eg Latex Surgical Glove size 7.0

Product Eg Latex Sensitive Glove size 6.5

Product Eg Latex Micro Glove size 6.5

Included in EUDAMED

•

Product Eg Box of 25 pairs of gloves

Product Eg Box of 25 pairs of gloves

Product Eg Box of 25 pairs of gloves

Product Eg Box of 25 pairs of gloves

Product Eg Shipper Box of 4 inners or 200 pairs of gloves

Product Eg Shipper Box of 4 inners or 200 pairs of gloves

Product Eg Shipper Box of 4 inners or 200 pairs of gloves

Product Eg Shipper Box of 4 inners or 200 pairs of gloves

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EUDAMED & Databases

• In Healthcare there are two different types of datapool: • Supply Chain Stakeholders such as distributors, wholesalers and Healthcare Institutions – such as hospitals, pharmacies, clinics etc. This is a practical requirement which not only gives traceability of product through to a specific patient but also helps to improve internal systems such as stock control, stock location, cost per episode, etc • This works very much in the same way as the retail sector. The manufacturer uploads predetermined data to the Global Data Synchronisation Network (GDSN) and the customers download it from there. This will be information required within the supply chain and although it may contain elements of those listed before there will be a lot more practical information such as weights and dimensions.

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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 • The 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 & Databases

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EUDAMED & Databases

• Actor Registrations • Within the MDR there are new responsibilities being put on Authorised Representatives and Importers in addition to the responsibilities already in place for manufacturers: • Each will need to submit their details to EUDAMED as an Economic Operator and will be issued an SRN • These details will need to be updated within 1 week if they were to change • Accuracy of the details will need to be confirmed after one year and every second year thereafter • Importers will also need to verify that the Manufacturer and AR have fulfilled their obligations, verify that imported devices are registered and add the importer details to any existing device registrations.

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• UDI (Product Registrations) EUDAMED & Databases Basic UDI-DI UDI-DIs

UDI-DIs

Applicable legislation (MDR) (*) 2. Basic UDI-DI value (*) 2.b. Basic UDI-DI Issuing entity (*) 6. Manufacturer SRN (*) 5. Name and address of manufacturer 7. Name and address and SRN of AR 9. Risk Class (*) Implantable (Y / N) (*) For IIb implantable: Suture, staple, dental filling, dental brace, tooth crown, screw, wedge, plate, wire, pin, clip, connector (Y/N) Measuring function (Y / N) (*) Reusable surgical instrument (Y / N) (*) Active device (Y / N) (*) Intended to administer / remove a medicinal substance (Y / N) (*) 11. A. Name and / or, if applicable, device model that identifies the devices(s) with this BASIC UDI-DI in the technical documentation and / or certificate or declaration of conformity (Name and / or model shall be provided)

0. UDI-DI value (*) .0.b UDI-DI Issuing entity (*) Secondary DI (value and issuing entity) 11.b. Reference, Article or Catalogue number (*) Direct marking (Y/N) (*) Direct marking UDI-DI value (*) Direct marking UDI-DI issuing entity (*) 1 Quantity of device(s) (*) 3. Type of UDI-PI (*) 4. Unit of use UDI-DI (*) 12. Clinical size (*) 14. Storage / handling conditions 10-15. Name(s) / Trade name(s) (including languages)

0. UDI-DI value (*) 0.b. Issuing entity (*) 1. Quantity per package (*) 24. Status

13. Additional product description 22. URL for additional information 16. Labelled as single use (Y/N) (*) 17. Maximum number of uses (*) 18. Device labelled as sterile (Y/N) (*) 19. Need for sterilisation (Y/N) (*)

20. Containing latex (Y/N) (*) 21. CMR / Endocrine disruptor 23. Critical warnings or contra-indications 8. Medical device nomenclature ( CND ) code ( 1 ) 24. Status 25. (A.2.6) Reprocessed single use (Y/N) (*) 26. (A.2.12) Annex XVI (*)

(*) may not be changed Mandatory

Mandatory if applicable Optional

27. (A.2.13) In the case of devices designed and manufactured by another legal or natural person as referred to in Article 10(15), the name, address and contact details of that Natural / legal person

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