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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
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
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
Membership NewsMembership News Archive

Parliament’s Public Accounts Committee releases AMR report

Following evidence sessions, Parliament's Public Accounts Committee has released their report into the risks of antimicrobial resistance (AMR). The committee is a cross-party group of MPs who scrutinises the value for money of Government projects, programmes and service delivery. The report highlights that there remains an "insufficient use of diagnostic tools to support the use of antimicrobials". It criticises the…
Ben Kemp
June 17, 2025
BIVDA updates Regulatory Affairs NewsletterBIVDA Updates Regulatory Affairs Newsletter ArchiveMembership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

New Chair of UKCA Subgroup announced

BIVDA is pleased to inform members that James Barker (Cytocell) has accepted the post of co-chair of the UKCA Subgroup. James will work alongside the existing chair, Emma Barringer. James is a regulatory professional with almost 20 years of experience in the IVD sector, currently serving as Regulatory Affairs Manager at Oxford Gene Technology (OGT) in Cambridge, UK. Over the…
Ben Kemp
June 17, 2025
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA announce new Post-Market Surveillance (PMS) regulations have taken effect

From the 16th June 2025, new legal requirements for monitoring the safety of medical devices take effect, as part of the MHRA's broader transformation of the UK’s medical device regulatory framework. The new Post-Market Surveillance (PMS) regulation is the first major overhaul of medical device regulation across Great Britain. The reform applies to all UKCA- and CE-marked devices placed on…
Ben Kemp
June 17, 2025
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