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European Commission Updates Regulatory Affairs Newsletter

European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Eudamed Workshop – 3rd December 2025, Brussels

Introduction to the EUDAMED Workshop The European Commission is organising two free hybrid workshops to support the onboarding of all concerned actors to EUDAMED, in preparation for the mandatory use of Actors, UDI/Devices, Notified bodies and Certificates and Market surveillance modules. The workshop provides an overview of the obligations under the Medical Devices Regulations (Regulation (EU) 2017/745 — MDR, and Regulation (EU) 2017/746 — IVDR). These workshops are a…
Ben Kemp
October 22, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Health Technology Assessment – Commission adopts rules for joint clinical assessments of medical devices and in vitro diagnostic medical devices

Health Technology Assessment - Commission adopts rules for joint clinical assessments of medical devices and in vitro diagnostic medical devices Today, the European Commission adopted an implementing regulation establishing the rules for joint clinical assessments of medical devices and in vitro diagnostic medical devices, under the Health Technology Assessment (HTA) Regulation. The implementing act provides detailed procedural rules for the…
Ben Kemp
October 22, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EC survey on medical device supply chain and shortages – invitation to participate (deadline: 03/11/2025)

Dear members, the European Commission (DG SANTE/HaDEA) has organised a survey to gather information to inform future policy regarding medical device supply chains, and management of shortages, and to provide resilience in the supply chains of medical devices. The general objective of the study, which started in June 2025 and will last six months, is to provide a comprehensive understanding…
Ben Kemp
October 22, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Commission publishes report on action to enhance access to healthcare

Commission publishes report on action to enhance access to healthcare The Commission has published a report showcasing EU4Health funded action to enhance access to healthcare across the EU. The report finds that healthcare coverage has a poverty-reducing impact, comparable to that of cash transfers such as unemployment benefits. Since 2019, however, there has been a rise in the share of…
Ben Kemp
October 2, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

CELEX:32024L2749R(02): Corrigendum to Directive (EU) 2024/2749 of the European Parliament and of the Council of 9 October 2024 amending Directives 2000/14/EC, 2006/42/EC, 2010/35/EU, 2014/29/EU, 2014/30/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/

I’ve highlighted items below that may impact IVDs (and Vet and RuO products) (Bold) or those impacting Vet use and RuO products but not IVDs (Italics). Corrigendum to Directive (EU) 2024/2749 of the European Parliament and of the Council of 9 October 2024 amending Directives 2000/14/EC, 2006/42/EC, 2010/35/EU, 2014/29/EU, 2014/30/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU a View article... This relates to…
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
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Team NB – Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746

Please see the update from Team NB, the Version 2 of the Position Paper on Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746. See also a useful comparison between version 1 and version 2. Team-NB-PositionPaper-BPG-IVDR-V1-20230225.docx → Team-NB TechDoc IVDR.pdf - Draftable
Ben Kemp
September 12, 2025
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(EU) 2024/1860 – IVDR 26 September 2025 deadline approaching

Critical Communication (EU) 2024/1860 – IVDR 26 September 2025 deadline approaching & impact on legacy devices not transitioning to the IVDR IVDD certified devices and Class D self-declared devices manufacturers to sign the written agreement with a Notified Body On 9 July 2024, the Regulation (EU) 2024/1860 amending the MDR and IVDR was published in the Official Journal of the…
Ben Kemp
August 28, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

CELEX:32025R1561: Regulation (EU) 2025/1561 of the European Parliament and of the Council of 18 July 2025 amending Regulation (EU) 2023/1542 as regards obligations of economic operators concerning battery due diligence policies

The European Commission have published the below legislation to delay the implication dates of certain requirements under the Batteries and Batteries Waste Due Diligence requirements. Regulation (EU) 2025/1561 of the European Parliament and of the Council of 18 July 2025 amending Regulation (EU) 2023/1542 as regards obligations of economic operators concerning battery due diligence policies (Text with EEA relevance) View…
Ben Kemp
August 4, 2025
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