"MEDICAL DEVICES NEWS Newsletter" Newsletter Issues

Foreword (16/05/2024)

We are continuing to support the implementation of the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR)! Keeping you informed about the latest developments, and all relevant news and events is a priority. Updates on the latest initiatives, surveys, publications, meetings, events and much more are here in this May 2024 newsletter!

For more information and regular updates, please consult our website HERE.

Adoption of new amendment to the MDR and IVDR (22/05/2024)

Adoption of new amendment to the MDR and IVDR

On the basis of the Commission proposal in January 2024, on 25 April 2024 the European Parliament adopted a new amendment to Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) as regards a gradual roll-out of the European database on medical devices (Eudamed), the obligation to inform in case of interruption or discontinuation of supply, and the transitional provisions for certain in vitro diagnostic medical devices. After the formal adoption by the Council as well, expected in May, the amending Regulation will enter into force on the day of its publication in the Official Journal of the European Union (OJEU).

The text of the amending Regulation and supporting information are available on the Commission’s webpage on extension of the transition periods provided for in the regulations.

Adoption of the second amendment to the MDR/IVDR standardisation request (22/05/2024)

Adoption of the second amendment to the MDR/IVDR standardisation request

On 24 April 2024, the Committee on Standards under Regulation (EU) No 1025/2012 on European standardisation delivered a positive opinion on the draft second amendment to the European Commission’s standardisation request (M/575) as amended (M/575 Amd 1) in support of Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). After the formal adoption of the Commission Implementing Decision as M/575 Amd 2, the act will be addressed to CEN and CENELEC for their acceptance, to become fully applicable.

This second amendment extends the validity of the MDR/IVDR standardisation request and the deadlines for the adoption of certain harmonised standards until 2028. Moreover, it adds and removes some standardisation items in Annexes I and II, and clarifies certain contents and requirements in Annex III.

For more, see the Commission’s webpage on harmonised standards.

New publications in the OJEU of references of harmonised standards in support of the MDR and IVDR (22/05/2024)

New publications in the OJEU of references of harmonised standards in support of the MDR and IVDR

On 8 March 2024, two Commission Implemented Decisions were published in the Official Journal of the European Union (OJEU) with new references of harmonised standards in support of Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). There are now 25 references of harmonised standards under the MDR and 13 under the IVDR to confer presumption of conformity with the requirements the standards aim to cover. 

For more, see the Commission’s webpage on harmonised standards.

New MDCG 2024-6, 7, 8 and 9 as preliminary (re-)assessment review form templates for MDR and IVDR (22/05/2024)

New MDCG 2024-6, 7, 8 and 9 as preliminary (re-)assessment review form templates for MDR and IVDR

In May 2024, the Medical Device Coordination Group (MDCG) endorsed the documents MDCG 2024-6 Preliminary assessment review (PAR) form template (MDR), MDCG 2024-7 Preliminary assessment review (PAR) form template (IVDR), MDCG 2024-8 Preliminary re-assessment review (PRAR) form template (MDR) and MDCG 2024-9 Preliminary re-assessment review (PRAR) form template (IVDR). They have been developed by the MDCG Subgroup on Notified Body Oversight (NBO).

For more, see the Commission’s webpage on guidance.

New MDCG 2024-5 on 'Guidance on content of the Investigator’s Brochure for clinical investigations of medical devices' (22/05/2024)

New MDCG 2024-5 on ‘Guidance on content of the Investigator’s Brochure for clinical investigations of medical devices’

In April 2024, the Medical Device Coordination Group (MDCG) endorsed the new document MDCG 2024-5 to provide guidance on content of the Investigator’s Brochure for clinical investigations of medical devices. It includes an Appendix A with cross-references between requirements in Annex XV chapter II of the MDR and the Clinical Investigation submission package.

For more, see the Commission’s webpage on guidance.

New MDCG 2024-4 on 'Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746' (22/05/2024)

New MDCG 2024-4 on ‘Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746’

In April 2024, the Medical Device Coordination Group (MDCG) endorsed the new document MDCG 2024-4 on safety reporting in performance studies of in vitro diagnostic medical devices under the IVDR. It includes an Appendix with a Performance Study Summary Safety Reporting Form.

For more, see the Commission’s webpage on guidance.

Revised MDCG 2022-9 on ‘Summary of safety and performance template’ (22/05/2024)

Revised MDCG 2022-9 on ‘Summary of safety and performance template’

In April 2024, the Medical Device Coordination Group (MDCG) endorsed the revised version of the document MDCG 2022-9 Rev.1 providing a summary of safety and performance template for in vitro diagnostic medical devices under the IVDR.

For more, see the Commission’s webpage on guidance.

New MDCG 2024-3 on ‘Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices’ (22/05/2024)

New MDCG 2024-3 on ‘Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices’

In March 2024, the Medical Device Coordination Group (MDCG) endorsed the new document MDCG 2024-3 to provide guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices. It includes an Appendix A with a Clinical Investigation Plan Synopsis Template.

For more, see the Commission’s webpage on guidance.

Notified bodies survey on certifications and applications (22/05/2024)

Notified bodies survey on certifications and applications

In March 2024, the Commission published the updated version of the Notified Bodies Survey on certifications and applications (MDR/IVDR) - Survey results of the 6^th NB survey with data status 31 October 2023 (small, medium and large dataset).

For more, see the Commission’s webpage on notified bodies.

Annual overview of devices subject to the clinical evaluation consultation procedure (CECP) – July 2022 - June 2023 (22/05/2024)

Annual overview of devices subject to the clinical evaluation consultation procedure (CECP) – July 2022 - June 2023

In March 2024, the Commission published the Annual overview of devices subject to the clinical evaluation consultation procedure (CECP) for the period July 2022 - June 2023.

For more, see the Commission’s webpage on Expert Panels – List of opinions provided under the CECP.

Advice on the indirect antiglobulin tests on request from the Medical Device Coordination Group (22/05/2024)

Advice on the indirect antiglobulin tests on request from the Medical Device Coordination Group

In March 2024, the Commission published the advice provided by the IVD Expert Panel on the indirect antiglobulin tests. The Medical Device Coordination Group (MDCG) requested this on the basis of Article 106 (10) (a) and (b) of Regulation (EU) 2017/745 on medical devices (MDR).

For more, see here.

New MDCG 2024-2 on ‘Procedures for the updates of the EMDN’ (22/05/2024)

New MDCG 2024-2 on ‘Procedures for the updates of the EMDN’

In February 2024, the Medical Device Coordination Group (MDCG) endorsed the new document MDCG 2024-2 on the Procedures for the updates of the European Medical Device Nomenclature (EMDN).

For more, see the Commission’s webpage on guidance.

New MDCG 2024-1 on ‘Guidance on the vigilance system for CE-marked devices and DSVG Templates’ (22/05/2024)

New MDCG 2024-1 on ‘Guidance on the vigilance system for CE-marked devices and DSVG Templates’

In January 2024, the Medical Device Coordination Group (MDCG) endorsed the new document MDCG 2024-1 DSVG 00 on Guidance on the vigilance system for CE-marked devices, with Device Specific Vigilance Guidance (DSVG) Templates on Cardiac ablation (MDCG 2024-1-1 DSVG 01), Coronary stents and associated delivery systems (MDCG 2024-1-2 DSVG 02), Cardiac implantable electronic devices (MDCG 2024-1-3 DSVG 03) and Breast implants (MDCG 2024-1-4 DSVG 04).

For more, see the Commission’s webpage on guidance.

New guidance document on MDR/IVDR Language requirements (22/05/2024)

New guidance document on MDR/IVDR Language requirements

In January 2024, the Commission issued a guidance document on MDR/IVDR Language requirements. It provides an overview of language requirements for medical device manufacturers covered by Regulation (EU) 2017/745 (MDR) and in vitro diagnostic medical devices covered by Regulation (EU) 2017/746 (IVDR) for the information and instructions that accompany a device in a specific country. The document was updated in March 2024.

For more, see the Commission’s webpage on guidance.

2024 sessions of the IMDRF (22/05/2024)

2024 sessions of the IMDRF

The first 2024 session of the International Medical Device Regulatory Forum (IMDRF), hosted by the U.S. Food and Drug Administration (FDA), took place from 11 to 15 March 2024 in Washington, DC.

A video developed during the 2023 EU Chair was published on the IMDRF website.

For more, see the IMDRF website and the Commission’s webpage on International Cooperation.

Meetings of the Medical Device Coordination Group (MDCG) (22/05/2024)

Meetings of the Medical Device Coordination Group (MDCG)

Meetings on 6-7 February 2024 and 13-14 May 2024 of the Medical Device Coordination Group (MDCG) took place with national competent authorities as well as sessions with the sectorial stakeholders.

For more, see the information on the MDCG meeting on 6-7 February 2024, the meeting between the MDCG and stakeholders on 6 February 2024, the MDCG meeting on 13-14 May 2024 and the meeting between the MDCG and stakeholders on 13 May 2024 from the Register of Commission Expert Groups and Other Similar Entities.

The updated list of 2024 planned meetings of MDCG and Subgroups is available from the Commission’s webpage on Medical Device Coordination Group Working Groups.

Updates on the applications for designation as a notified body under the MDR and the IVDR (22/05/2024)

Updates on the applications for designation as a notified body under the MDR and the IVDR

The European Commission updated the available information on the applications for designation as a notified body under Regulations (EU) 2017/745 on medical devices (MDR) and 2017/746 on in vitro diagnostic medical devices (IVDR) as an overview at each stage of the process.

For more, see the Commission’s webpage on Notified Bodies.

New project on combined studies (22/05/2024)

New project on combined studies

The European Commission, together with national authorities, ethics committees, the European Medicines Agency and stakeholders presented a report to analyse the current challenges faced when conducting combined studies and possible ways forward to streamline the regulatory landscape. The initiative is conducted in the context of the COMBINE project addressing combined studies, in which medicinal products are assessed together with medical devices or in vitro diagnostic medical devices.

For more, see the Commission’s webpage on combined studies.

Dashboard on monitoring of availability of medical devices on the EU market (22/05/2024)

Dashboard on monitoring of availability of medical devices on the EU market

In January 2024, in the context of the ‘Study supporting the monitoring of availability of medical devices on the EU market’, the Commission developed a dashboard presenting an overview of the data gathered from different stakeholders. In addition, comparable data from previous surveys of notified bodies conducted by the Commission have been integrated into the dashboard.

Report and dashboard on reprocessing of single-use devices (22/05/2024)

Report and dashboard on reprocessing of single-use devices

The Commission outsourced a study on the implementation of the provisions on reprocessing of single-use devices established in the Medical Devices Regulation. The final report and the interactive dashboard of the ‘Study on the implementation of Article 17 of Regulation (EU) 2017/745 on medical devices on the EU market’ were published in April 2024.

For more, see here and the Commission’s webpage on reprocessing of medical devices.

First outcomes of the EU JAMS 2.0 project - Joint Action on Reinforced Market Surveillance for Medical Devices (22/05/2024)

First outcomes of the EU JAMS 2.0 project - Joint Action on Reinforced Market Surveillance for Medical Devices

JAMS 2.0 is a Joint Action co-funded by the European Union under the EU4Health programme involving 24 EU Member States. The goal is to reinforce the market surveillance for medical devices and in vitro diagnostic devices and to foster cooperation between National Competent Authorities (NCAs). The project started in November 2023 and runs for 36 months with several activities across 8 technical and operational work packages.

For more information and the first project outcomes, see here.

Keep in touch online! (16/05/2024)

Keep in touch online!

Stay up-to-date on all information related to medical devices and in vitro medical devices, visit the Medical Devices section on the European Commission’s Public Health website regularly. Register with the stakeholder’s database here to stay up-to-date and receive the quarterly newsletter.

Foreword (18/12/2023)

We are continuing to support the implementation of the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR)! Keeping you informed about the latest developments, and all relevant news and events is a priority. Updates on the latest initiatives, surveys, publications, meetings, events and much more are here in this December newsletter!

For more information and regular updates, please consult our website HERE.

Keep in touch online! (19/12/2023)

Keep in touch online!

Stay up-to-date on all information related to medical devices and in vitro medical devices, visit the Medical Devices section on the European Commission’s Public Health website regularly. Register with the stakeholder’s database here to stay up-to-date and receive the quarterly newsletter.

Online stakeholder survey in the context of the “Study on Regulatory Governance and Innovation in the field of Medical Devices” (19/12/2023)

Running until 31 January 2024.

Online stakeholder survey in the context of the “Study on Regulatory Governance and Innovation in the field of Medical Devices”

Within the ongoing “Study on Regulatory Governance and Innovation in the field of Medical Devices”, the European Commission has launched an online stakeholder survey on different aspects related to regulatory governance and innovation for medical devices and in vitro diagnostic medical devices. The survey is available here.

Meeting of the Employment, Social Policy, Health and Consumer Affairs Council - Health (30/11/2023)

Meeting of the Employment, Social Policy, Health and Consumer Affairs Council - Health

Meeting on 30 November 2023, the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) - Health discussed a point on the implementation of the Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). For more, see here. 

Publication in the OJEU of Commission Delegated Regulation (EU) 2023/2197 as regards the assignment of Unique Device Identifiers (UDIs) for contact lenses (19/12/2023)

Publication in the OJEU of Commission Delegated Regulation (EU) 2023/2197 as regards the assignment of Unique Device Identifiers (UDIs) for contact lenses

After the scrutiny by the European Parliament and the Council, the Commission Delegated Regulation of 10 July 2023 amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for contact lenses has been published in the Official Journal of the European Union (OJEU): see OJ L, 2023/2197, 20.10.2023. It will become applicable from 9 November 2025. 

Update of MDCG 2022-11 Position Paper: Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements (19/12/2023)

Update of MDCG 2022-11 Position Paper: Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements

The Medical Device Coordination Group (MDCG) endorsed MDCG 2022-11 Rev.1, an update of the position paper with the notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements. The update includes a new section “Call to notified bodies to streamline the certification process” and a revision of the section “Call to manufacturers to transition to the Regulations and submit their applications for certification without further delay”. For more, see the Commission’s webpage on Guidance.

Online survey for MD and IVD manufacturers and authorised representatives on the status of MDR and IVDR implementation (19/12/2023)

Running until 15 January 2024.

Online survey for MD and IVD manufacturers and authorised representatives on the status of MDR and IVDR implementation

Updates on the applications for designation as a notified body under the MDR and the IVDR (19/12/2023)

Updates on the applications for designation as a notified body under the MDR and the IVDR

The European Commission updated the available information on the applications for designation as a notified body under Regulations (EU) 2017/745 on medical devices (MDR) and 2017/746 on in vitro diagnostic medical devices (IVDR) as an Overview at each stage of the process. For more, see the Commission’s webpage on Notified Bodies.

Updated MDR/IVDR notified bodies survey on certifications and applications (19/12/2023)

Survey results with data status 30 June 2023

Updated MDR/IVDR notified bodies survey on certifications and applications

The European Commission updated the document with the Notified bodies survey on certifications and applications under Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), with data status 30 June 2023. For more, see the Commission’s webpage on Notified Bodies.

Meetings of the Medical Device Coordination Group (MDCG) (19/12/2023)

Meetings of the Medical Device Coordination Group (MDCG)

Meetings on 10-11 October 2023 and on 11-12 December 2023 of the Medical Device Coordination Group (MDCG) took place with national competent authorities as well as sessions with the sectorial stakeholders. For more, see the information on the meeting between the MDCG and stakeholders on 10 October 2023, the MDCG meeting on 10-11 October 2023 and the MDCG meeting on 11-12 December 2023 from the Register of Commission Expert Groups and Other Similar Entities. The updated lists of 2023 planned meetings of MDCG and Subgroups and the new 2024 planned meetings of MDCG and Subgroups are available from the Commission’s webpage on Medical Device Coordination Group Working Groups.

New MDCG 2023-4 on Medical Device Software (MDSW) - Hardware combinations: guidance on MDSW intended to work in combination with hardware or hardware components (19/12/2023)

New MDCG 2023-4 on Medical Device Software (MDSW) - Hardware combinations: guidance on MDSW intended to work in combination with hardware or hardware components

The Medical Device Coordination Group (MDCG) endorsed a new guidance document, MDCG 2023-4, on Medical Device Software (MDSW) - Hardware combinations, as guidance on MDSW intended to work in combination with hardware or hardware components. For more, see the Commission’s webpage on Guidance.

Berlin session of the EU 2023 Chair of the Management Committee of the International Medical Device Regulators Forum (IMDRF) (19/12/2023)

Berlin session of the EU 2023 Chair of the Management Committee of the International Medical Device Regulators Forum (IMDRF)

Under the EU 2023 Chair of the Management Committee of the International Medical Device Regulators Forum (IMDRF), following the session in Brussels, Belgium held on 27-28 March 2023, a new session took place in Berlin, Germany on 25-26 September 2023 (see agenda). For more information, see EU chairs IMDRF in 2023 from the Commission’s webpage on International Cooperation, and the specific webpage IMDRF 2023 EU Chair.

Expert Panel advice on SARS-CoV-2 neutralising antibodies (19/12/2023)

Expert Panel advice on SARS-CoV-2 neutralising antibodies

The Medical Device Expert Panels issued advice on SARS-CoV-2 neutralising antibodies on request from the Medical Device Coordination Group (MDCG). For more, see the Commission’s webpage on Expert Panels. 

MDR and IVDR communication survey (19/12/2023)

MDR and IVDR communication survey

Designation of EU Reference Laboratories (EURLs) (19/12/2023)

Designation of EU Reference Laboratories (EURLs)

Resulting from the call for applications in 2022, the European Commission has designated five EU Reference Laboratories (EURLs) for certain class D in vitro diagnostic medical devices (IVDs). For more, see the Commission’s webpage on In Vitro Diagnostics - EU reference laboratories (EURLs). 

New Q&A document on transitional provisions for products without an intended medical purpose covered by Annex XVI to the MDR (19/12/2023)

New Q&A document on transitional provisions for products without an intended medical purpose covered by Annex XVI to the MDR

The European Commission issued a new questions and answers (Q&A) document to provide information on the transitional provisions for products without an intended medical purpose covered by Annex XVI to Regulation (EU) 2017/745 on medical devices (MDR), for which common specifications have been set out in Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 as amended by Commission Implementing Regulation (EU) 2023/1194 of 20 June 2023. For more, see the Commission’s webpage on Guidance.

New MDCG 2023-6 - Guidance on demonstration of equivalence for Annex XVI products (19/12/2023)

New MDCG 2023-6 - Guidance on demonstration of equivalence for Annex XVI products

The Medical Device Coordination Group (MDCG) endorsed MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products, as a guide for manufacturers and notified bodies for product without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 on medical devices (MDR). For more, see the Commission’s webpage on Guidance.

Revision of MDCG 2021-6: questions and answers regarding clinical investigations (19/12/2023)

Revision of MDCG 2021-6: questions and answers regarding clinical investigations

The Medical Device Coordination Group (MDCG) endorsed MDCG 2021-6 Rev.1 Regulation (EU) 2017/745 – Questions & Answers. The revised version includes a number of new and updated questions and answers, and improvements in the Annexes. For more, see the Commission’s webpage on Guidance.

Updated manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (19/12/2023)

Updated manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices

The European Commission issued version 3 of the Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices, as well as a Background note on the use of the Manual on borderline and classification for medical devices under the Directives. For more, see the Commission’s webpage on Guidance. 

New MDCG 2023-5 - Guidance on qualification and classification of Annex XVI products (19/12/2023)

New MDCG 2023-5 - Guidance on qualification and classification of Annex XVI products

The Medical Device Coordination Group (MDCG) endorsed MDCG 2023-5 Guidance on qualification and classification of Annex XVI products, as a guide for manufacturers and notified bodies for product without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 on medical devices (MDR). For more, see the Commission’s webpage on Guidance.