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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
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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
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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
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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
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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
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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
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Commission publishes proposal for extension of transition periods for MDR

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…

January 8, 2023
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Commission issues new guidance documents for MDR/IVDR

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…

January 4, 2023
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Reuters reports on EU medical device “chaos”

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…

December 20, 2022
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UK Life Sciences Council issues joint statement on HealthTech regulatory reform

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…

December 16, 2022
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