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European Commission Updates Regulatory Affairs Newsletter

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CELEX:32024R2847R(02): Corrigendum to Regulation (EU) 2024/2847 of the European Parliament and of the Council of 23 October 2024 on horizontal cybersecurity requirements for products with digital elements and amending Regulations (EU) No 168/2013 and

Corrigendum to Regulation (EU) 2024/2847 of the European Parliament and of the Council of 23 October 2024 on horizontal cybersecurity requirements for products with digital elements and amending Regulations (EU) No 168/2013 and (EU) View article...
Ben Kemp
July 4, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EUDAMED Production Release note 2.15.0

Release note v 2.15.0 Jun 26, 2025 The new version of EUDAMED 2.15.0 has been deployed. The Information Centre – EUDAMED (Production) provides the full release note document here: EUDAMED Release Note (v2.15) and the full documentation on the release is available as follows: Welcome to the EUDAMED Information Centre. DTX: The XSD schema for this release has the following version: 3.0.16. The release affects the…
Ben Kemp
July 4, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EU CITES proposal to amend appendices under the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES)

Dear members, this could potentially impact some manufacturers regarding some very specific raw materials derived from animals. I’m aware of at least one material derived from sharks that could be impacted. Council Decision (EU) 2025/1314 of 23 June 2025 on the submission, on behalf of the European Union, of proposals for amendments to the appendices to the Convention on International…
Ben Kemp
July 4, 2025
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EU Tariffs

This is an additional legislation regarding relaxation of tariff codes, which relaxes tariffs, except for Russia and Belarus, but again does not to mixtures, components or products. Council Regulation (EU) 2025/1303 of 23 June 2025 amending Regulation (EU) 2021/2278 suspending the Common Customs Tariff duties referred to in Article 56(2), point (c), of Regulation (EU) No 952/2013 on certain agricultural…
Ben Kemp
July 4, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EU RoHS – 2025

Please be advised that Oko Institute, have been appointed as the external consultant to review the June 2025 batch of EU RoHS exemption pack renewals or refusals. If any of these Annex III or Annex IV exemptions are applicable see the table for interested registrants. MedTech Europe usually coordinate responses for the European MD/IVD market. Note that there will need…
Ben Kemp
June 26, 2025
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EU Standardization – consultation responses by 21st July 2025

EU consultation on the harmonization of standards process. EU want feedback by 21st July. Member responses need to constructive rather than a whinge. Standardisation Regulation – revision And Erik Vollebregt’s commentary https://www.linkedin.com/posts/erikvollebregt_standardization-medicaldevices-invitrodiagnostics-activity-7343026050060238848-JDqs?utm_source=share&utm_medium=member_ios&rcm=ACoAAAAeH9EBFpe2TIKx6c7gKShKVeAb46UjtpM I can send this out, but let me know if you want a BIVDA response (this directly impacts NI), and any specific text you’d like to included in…
Ben Kemp
June 26, 2025
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MDR/IVDR Targeted Evaluation – Final summary report published

  The European Commission has published the Final Summary Report of its Targeted Evaluation of the EU Medical Devices and In Vitro Diagnostic Regulations (MDR/IVDR). Early analysis by MedTech Europe has shown the following: Reforms should prioritise simplification, a risk-based and proportionate approach, and clearer guidance to enhance implementation. There is support for harmonised EU regulations; however, compliance costs remain…
Ben Kemp
June 24, 2025
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MDCG 2025-4 – Guidance on the safe making available of medical device software (MDSW) apps on online platforms (June 2025)

Dear members, please see the new MDCG guidance regarding making available Medical Device Software, the guidance includes IVD software in scope. Note that this will also include provision of software via online platforms to Northern Ireland, as EU IVD Regulation also applies to Northern Ireland. MDCG 2025-4 - Guidance on the safe making available of medical device software (MDSW) apps…
Ben Kemp
June 18, 2025
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