MEDICAL DEVICES NEWS

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.

Running until 15 January 2024.

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

MDR and IVDR communication survey

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

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.

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.

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.

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. 

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.

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 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.

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. 

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.

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.

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.

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). 

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. 

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.

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.