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MDR/IVDR Amending Regulation published

Following last week’s formal approval of the European Commission’s proposal to extend the transition timelines for certain ‘legacy devices’ and eliminate the ‘sell-off period’ from the Medical Device Regulation (MDR, 2017/745) and the In Vitro Diagnostics Regulation (IVDR, 2017/746), Amending Regulation (EU) 2023/607 has now been published. The Preamble to the Regulation states, as industry…

March 20, 2023
Maria Donawa to speak at Vienna Conference on Clinical Studies

Donawa Lifescience President, Maria E. Donawa M.D., is scheduled to speak at the ​2nd Conference on Clinical Studies with Medical Devices and IVDs, taking place in Vienna, Austria, on 30-31 March 2023. This year’s conference is designed to provide a wealth of information for both medical device and in vitro diagnostic clinical investigations, with a…

March 18, 2023
UK Budget includes statement on medical device future regulation potential

In the UK Chancellor of the Exchequer’s budget statement on Wednesday 15 Marcy 2023, the potential future of medical device regulation was included. Based on an interim report from Sir Patrick Vallance, UK Government Chief Scientific Adviser, dated 8 March 2023, the Chancellor announced a commitment to some of the early outcomes of the ‘Regulatory…

March 18, 2023
Frequency of complete re-assessments of notified bodies under MDR extended

Commission Delegated Regulation (EU) 2023/502 of 1 December 2022, which took on 11 March 2023, reduces the frequency of complete re-assessments of notified bodies from three years (1st complete re-assessment) and four years (following the 1st) to every 5 years in both cases; however, the competent authorities have the liberty to decide if complete re-assessment…

March 14, 2023
European Council approves MDR transition period extension

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…

March 8, 2023
European Parliament votes to extend MDR transition period

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…

February 20, 2023