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BIVDA & MHRA UK MDR Classification Workshop – 4th December

Date and Time: Thursday 4th December, 11am to 3:30pm Make sure to register for BIVDA's workshop with the MHRA on the proposed classification rules, intended to be introduced under the Pre-Market SI. This is a crucial opportunity to work through the proposed IVD classification changes to the UK MDR with the MHRA and fellow BIVDA members. Members can register here.
Ben Kemp
November 26, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA update on EU MIR for Northern Ireland

Dear Members, I received the following feedback from MHRA regarding the EU MIR for Northern Ireland incident reporting to the EU IVD Regulation. ‘We have started accepting the current versions of MIR 7.3.1 as of Monday 03/11/2025 in respect to NI reporting. We will continue to accept EU MIR 7.2.1 until 7.3.1 becomes mandatory. We’ll be adding some guidance into…
Ben Kemp
November 13, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Position paper on Digital Label for importer and authorised representative published as a joint paper

Dear Members, please see below link to the MedTech Europe Position Paper on digital labelling. This is part of the ongoing advocacy to promote the adoption digital labelling as part of the reforms to the IVDR/MDR. Digital label for authorised representative and importer - MedTech Europe
Ben Kemp
November 13, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

MedTech Europe quarterly webinar for Partner Trade Associations around the World (Mon, 24 Nov, 3-4 pm CET)

On Monday, 24 Nov 2025 from 15:00 to 16:00 pm CET (Brussels time), MedTech Europe will host its next quarterly webinar regarding the implementation status of the EU In Vitro Diagnostic Medical Devices and Medical Devices Regulations (IVDR and MDR) for its partner medtech trade associations around the world. The webinar will be 60 minutes in duration including a 30-minute Q&A. Due to…
Ben Kemp
November 13, 2025
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Your Due Diligence Requirements Globally – 2025 Deadlines [2 Expert Guides]

From Disclosure To Enforcement: Navigating The World's Emerging Human Rights Due Diligence Regulations Based on our expert webinar, Emerging Human Rights Due Diligence Regulations Across the Globe - this guide establishes the foundational WHY and WHERE of mandatory Due Diligence, covering the global shift: Global Enforcement: The history of HRDD, from the Rana Plaza tragedy to binding law. US Import…
Ben Kemp
November 13, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EU Network of Comprehensive Cancer Centres reaches key milestone

EU Network of Comprehensive Cancer Centres reaches key milestone The European Network of Comprehensive Cancer Centres (EUnetCCC), a key flagship initiative of Europe’s Beating Cancer Plan, was launched in Paris this week. Supported by €90 million of EU investment under the EU4Heath Programme, the objective of the Network is to support cancer patients in accessing high-quality prevention, diagnosis, treatment and…
Ben Kemp
November 13, 2025
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