Register now: EU webinar on non-communicable diseases Friday 16 May 2025, 10.00-13.00 Non-communicable diseases (NCDs) such as cardiovascular diseases, diabetes, chronic respiratory diseases, mental disorders, neurological disorders, or cancer are responsible for 80% of the disease burden in the EU Member States and the leading causes of avoidable premature deaths. The human and financial costs of NCDs are high and…
Ben KempMay 9, 2025
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 KempMay 9, 2025
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 KempMay 9, 2025
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 KempMay 9, 2025
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 KempMay 9, 2025
Dear Members, please see the following update from MedTech Europe on the draft EU POPs Regulation regarding UV-328. It would appear that we will see some divergence in the requirements between the EU and UK, with the EU legislation applying to products placed on the NI Market. Dear members, We are writing to inform you that the revised draft delegated…
Ben KempMay 9, 2025
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 KempMay 9, 2025
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 KempMay 9, 2025
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 KempMay 9, 2025