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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 Archive

Biocides: EU active substance expiry dates

EU active substance expiry dates postponed Active substance expiry dates postponed whilst the renewal evaluation is completed in the EU. From 30 June 2025 to 31 December 2027 Copper sulphate pentahydrate (CAS 7758-99-8 EC 231-847-6) in product type 2 Benzoic acid (CAS 65-85-0 EC 200-618-2) in product types 3 and 4 3-iodo-2-propynylbutylcarbamate (IPBC) (CAS 55406-53-6 EC 259-627-5) in product type…
Ben Kemp
May 1, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FW: CELEX:32025D0799: Council Decision (EU) 2025/799 of 14 April 2025 establishing the position to be taken on behalf of the European Union within the Joint Committee established by the Agreement on the withdrawal of the United Kingdom of Great Britain an

Please see the EU position to include 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) 2019/1020 and Directive (EU) 2020/1828 (Cyber Resilience Act), with the exception of Articles 5 and 67 thereof, shall be added to Annex 2 to the…
Ben Kemp
April 30, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

NANDO update – 2 new Notified Bodies for IVDR added

Dear Members, not one, but two new notified bodies designated under the EU IVD Regulation 2017/746 and added to NANDO: SGS Belgium NV and IMQ Instituto Italiano Del Marchio Di Qulaita S.P.A Italy This makes it 16 Notified Bodies so far, out of the 22 applications. As always, if interested in using these new notified bodies you need to check…
Ben Kemp
April 30, 2025
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MDCG – 2019-6 Rev 5 Q&A: Requirements relating to notified bodies

EU MDCG have published the 5th Revision of the Q&A: : Requirements relating to notified bodies – MDCG 2019-6 Rev 5 Although applicable to EU Notified bodies, it is useful to see what the EU Competent authorities are asking notified bodies to require, and allows companies to prepare supporting evidence accordingly. The latest update includes improved content on structured dialogue,…
Ben Kemp
February 21, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

CI/PS coordinated assessment pilot officially launched

Please note that the European Commission has launched a dedicated website for clinical investigations and performance studies coordinated assessment pilot: Medical Devices - Clinical investigations and performance studies - European Commission and with this also officially opened the call for expression of interest for the Clinical Investigations (MD) pilot: Pilot coordinated assessment for CI/PS - European Commission For medical devices:…
Ben Kemp
February 14, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Health Technology Assessment: The Commission opens first request submission period for joint scientific consultations

The European Commission has launched the first request submission period for joint scientific consultations (JSCs) under the Health Technology Assessment Regulation (EU) 2021/2282. The JSCs enable health technology developers (HTDs) to exchange information with regulatory authorities on their development plans for a medicinal product or medical device. They also enable HTDs to obtain guidance on the information, data, analyses, and…
Ben Kemp
February 7, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Advice on SARS-CoV-2 on request from the Medical Device Coordination Group (29 January 2025)

At the request of EU MDCG, EMA Expert Scientific Committee was asked to provide a scientific opinion on the current status of SAR-CoV-19, so they can review the current classification as an EU Class D device. Please find below link to the Scientific opinion and the update on the MDCG webpage. Future updates of the MDCG Guidance on classification will…
Ben Kemp
February 7, 2025
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