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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