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Ben Kemp

European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveMembership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

MDR/IVDR Targeted Evaluation – Final summary report published

  The European Commission has published the Final Summary Report of its Targeted Evaluation of the EU Medical Devices and In Vitro Diagnostic Regulations (MDR/IVDR). Early analysis by MedTech Europe has shown the following: Reforms should prioritise simplification, a risk-based and proportionate approach, and clearer guidance to enhance implementation. There is support for harmonised EU regulations; however, compliance costs remain…
Ben Kemp
June 24, 2025
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MHRA chief announces the agency’s strategic aims

  On a recent trip to Washington D.C., the Chief Executive of the MHRA Lawrence Tallon outlined the agency's strategic direction. Mr Tallon stated his intention to build a world-class safety and surveillance system enabled by comprehensive real-world data for the protection of patients and the public. In line with BIVDA's priorities, he also signalled that the agency seeks to…
Ben Kemp
June 24, 2025
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NHS set to DNA test all newborns to predict disease risk

Over the next decade, the NHS in England plans to sequence the DNA of every newborn to identify their risk of developing hundreds of genetic conditions. This initiative is aligned with the government's strategy to shift healthcare towards prediction and prevention, set to be reflected in the upcoming NHS 10-Year Plan. This includes a £650 million investment in DNA research…
Ben Kemp
June 24, 2025
Membership NewsMembership News Archive

BIVDA webinar: How Carbon Credits supercharge your Net Zero commitments

BIVDA recently hosted a webinar featuring Andy Harris from Nature Broking and Sarah Joy Newton from Amethyst Connect covering how high integrity, UK-based carbon credits can support members' sustainability journey, help with tender compliance, and have a positive impact on your business. In case you missed it or would like to watch it again, members can view the webinar here.
Ben Kemp
June 24, 2025
HighlightsHighlights Archive

Home testing kits for lifesaving checks against cervical cancer

Women across England who haven’t come forward for vital health checks will be offered home-testing kits as part of the cervical screening programme under the upcoming 10 Year Health Plan. The ground-breaking initiative aims to revolutionise cervical cancer prevention rates by tackling deeply entrenched barriers that keep some women away from potentially life-saving screenings, including a fear of discomfort, embarrassment,…
Ben Kemp
June 24, 2025
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Airlock round 2 open until 14 July

Applications for the second round of the MHRA AI Airlock programme have opened following a successful pilot phase. The first round saw four breakthrough AI technologies, including software that could help doctors create personalised cancer treatment plans, and a tool to help hospitals, AI developers, and regulators monitor AI performance in real time, tested in a regulatory ‘sandbox’ environment. Similar…
Ben Kemp
June 23, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

For information: OSOA provisional agreement reached by Council/Parliament

Dear members, MedTech Europe update on the EU progress with the proposed One Substance One Assessment (OSOA) legislation. Dear members, I hope you are all well. We are writing to update you on the latest developments on the ‘One Substance, One Assessment’ (OSOA) package of legislative proposals, including targeted amendments to MDR, RoHS, and the proposal for a new chemicals…
Ben Kemp
June 18, 2025
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