The European Council (EC) has approved a measure to extend the transition period for medical devices under the Medical Devices Regulation (MDR, 2017/745) and to remove the sell-off provisions for existing products as required under MDR and the In Vitro Diagnostic Medical Devices Regulation (IVDR, 2017/746). On 7 March 2023, the Council voted 27-0 to…
As indicated in an earlier news item, while the EU ENVI Committee approved the second corrigenda for the MDR and IVDR, at the EPSCO Council meeting on 9 December, it is reported that the European Commission accepted a concession from the member states to ‘voluntarily’ introduce one Eudamed module by May 2020. The module…
One month after members of the European Council expressed support for delaying the Medical Device Regulation (MDR, 2017/745) transition period in a meeting of the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO), the European Commission on 6 January 2023 adopted a proposal to allow medical device manufacturers more time to complete certification of…
The European Commission issued new guidance documents in December 2022 relating to both the Medical Device Regulation (MDR, 2017/745) and the In Vitro Diagnostic Regulation (IVDR, 2017/746), as follows: MDCG 2022-19: Performance study application/notification documents under Regulation (EU) 2017/746 MDCG 2022-20: Substantial modification of performance study under Regulation (EU) 2017/746 MDCG 2022-4 rev.1: Guidance on…
Maggie Fick, a reporter with Reuters.com, published an article titled ‘Medical device makers drop products as EU law sows chaos’ on 19 December 2022, commenting, quite accurately “A law created to stop one criminal company’s actions 10 years ago now endangers patients’ lives, including children, and European manufacturing sites. Is that what the EU wants…
The Life Sciences Council of the United Kingdom (UK) has today published a joint statement on a new agreement with other stakeholders, including UK industry representatives, to “accelerate the delivery of the future UK HealthTech regulatory system”. The statement, copy available from here, explains that “The reform of the UK’s Medical Device regulation offers a…
Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022, laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 (MDR) and Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of the MDR as regards reclassification of…
The European Commission intends to extend the transition period under the Medical Devices Regulation (MDR, 2017/745) for an additional three years. The proposal was raised at the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council meeting on 9 December 2022 by the European Commissioner for Health, Stella Kyriakides, and supported unanimously by the member…
Although the proposals for easing the current regulatory burden on medical device manufacturers as a result of delayed implementation of the MDR announced on 9 December may go some way to avoiding the disappearance of many medical devices from the European market, German associations from various groups have expressed their concern in recent weeks. Spectaris,…
The US Food and Drug Administration (FDA) has issued a draft guidance document titled ‘Content of Human Factors Information in Medical Device Marketing Submissions: Draft Guidance for Industry and Food and Drug Administration Staff“ The draft is intended to be, when finalised, a companion guidance to document ‘Applying Human Factors and Usability Engineering to Medical…
