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Ben Kemp

European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EU MIR form updated to version 7.3.1

Dear Members, please be advised that the MDCG have updated the Manufacturer Incident Reporting form (MIR form) to version 7.3.1 which will become mandatory from November 2025 (6 month transition). This includes updates for machine to machine data transfers. View article... Note 1 : the form is not compatible with EUDAMED, and can not be used to generate XML output…
Ben Kemp
May 9, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EU IVDR Harmonization request updated

Dear Members, please be advised the MDCG have updated the EU IVD Regulation standards harmonisation request to include two updated European standards EN 556-1:2024 - Sterilization of medical devices - Requirements for medical devices to be designated “STERILE” - Part 1: Requirements for terminally sterilized medical devices EN556-2:2024 - Sterilization of medical devices - Requirements for medical devices to be…
Ben Kemp
May 9, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

(EU) 2024/1860 – IVDR 26 May 2025 deadline approaching

A reminder that manufacturers wanting to keep EU IVDD certified products on the market will need an EU IVD Regulation compliant QMS in place by 26th May 2025. And also a reminder to not delay submitting products for IVDR conformity assessment. (EU) 2024/1860 – IVDR 26 May 2025 deadline approaching Manufacturers are required to put in place an IVDR compliant…
Ben Kemp
May 9, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

New MedTech Europe leaflet – Four urgent targeted measures – MDR/IVDR implementation

As part of MTE's advocacy efforts on the Future of Regulatory System they are pleased to share the new leaflet outlining four key urgent targeted measures. Our sector calls for these key targeted measures to support the implementation of the MDR & IVDR. They should kick-in urgently and ahead of the anticipated legal reform in 2026. The four targeted measures…
Ben Kemp
May 9, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Updates (WC 5 May)

Open general import licence (OGIL) Page summary: This open general import licence (OGIL) permits the importation of all goods into the United Kingdom, subject to the various exceptions it sets out. Change made: Explanatory note updated to advise that applications regarding the licensing of imports of nuclear materials should be made through the digital ‘apply for an import licence’ service.…
Ben Kemp
May 9, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Updates (WC 5 May)

Joint statement on the Withdrawal Agreement Joint Committee, 29 April 2025 Page summary: The Minister for the Cabinet Office, Nick Thomas Symonds and the European Commissioner Maroš Šefčovič gave a joint UK-EU statement on 29 April 2025. Change made: First published. Time updated: 11:45am, 29 April 2025 DECISION No 3/2025 of the Joint Committee established by the Agreement on the…
Ben Kemp
May 9, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Updates (WC 5 May)

Frontier AI: capabilities and risks – discussion paper Page summary: A discussion paper on the capabilities of, and risks from, frontier AI. Change made: Added AI 2030 Scenarios Report (Annex C). Time updated: 11:00am, 28 April 2025 UK-Japan Memorandum of Cooperation on quantum science and technology Page summary: Memorandum of Cooperation signed by the UK and Japan in April 2025…
Ben Kemp
May 9, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DEFRA Updates (WC 5 May)

Certification Logistics Pilot: import requirements Page summary: Guidance on the import requirements for businesses participating in the pilot, including guidance for certifying officers. Change made: The businesses that are participating in the Certification Logistics Module Pilot (CLP) have changed. Time updated: 12:01am, 27 April 2025 Recyclability assessment methodology: how to assess your packaging waste Page summary: An overview of the…
Ben Kemp
May 9, 2025
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