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Ben Kemp

MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EUDAMED onboarding – Commission’s EUDAMED Workshops: 8 Oct, Rome, Italy; 3 Dec, Brussels, Belgium

Registration is open for the new workshops on EUDAMED, organised by DG SANTE, European Commission: 8 October 2025, Rome, Italy 🇮🇹 3 December 2025, Brussels, Belgium 🇧🇪 For in person or online participation, you can register here. The workshop programme and venues are displayed at the workshops page : Audience: economic operators, notified bodies, national authorities, and other stakeholders Content:…
Ben Kemp
September 22, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

The Customs (Tariff and Miscellaneous Amendments) (No. 3) Regulations 2025

The Customs (Tariff and Miscellaneous Amendments) (No. 3) Regulations 2024 Regulation 2 amends the definition of “the authorised use document” in regulation 32(2) of the Customs (Special Procedures and Outward Processing) (EU Exit) Regulations 2018 (S.I. 2018/1249) to refer to a new version of that document. The new version of this document removes one commodity code to align with changes…
Ben Kemp
September 22, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

European Commission launches consultation to streamline MedTech regulation

Please note that the EU has launched a follow up focused consultation on the streamlining of the EU MDR and IVDR. This is a more focused consultation following on from the previous consultation, and the EC are not intending to conduct a full review of the implementation of the MDR and IVDR. MedTech Europe are very focused on these consultations,…
Ben Kemp
September 22, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EU Data Act – Updated Q&A

EU have updated the Q&A on the Data Act. The act entered force 11 Jan 2024, and the date of application was 12th Sept 2025. EU Data Act gives users control over data from connected devices Commission publishes Frequently Asked Questions about the Data Act | Shaping Europe’s digital future
Ben Kemp
September 22, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Updates – 15th Sept

Trade Specialised Committee on Level Playing Field for Open and Fair Competition and Sustainable Development Page summary: This page brings together information about this Trade Specialised Committee under the EU-UK Trade and Cooperation Agreement. Change made: Updated with : Minutes – Trade Specialised Committee on Level Playing Field for Open and Fair Competition and Sustainable Development under the EU-UK Trade…
Ben Kemp
September 22, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Animal and Plant Health Agency Updates – WC 15 Sept

Find a professional to certify export health certificates Page summary: A list of organisations in England, Scotland and Wales that inspect and certify animals and animal products for export. The list does not include every certifier. Change made: Updated the list of professionals who can certify export health certificates in England. Time updated: 1:03pm, 12 September 2025 Export of processed…
Ben Kemp
September 22, 2025
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