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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

COMBINE programme for clinical trials and medical devices endorsed by Member States

COMBINE programme for clinical trials and medical devices endorsed by Member States National authorities in Member States have endorsed a new strategy for the COMBINE programme, a cross-sector initiative to streamline combined studies of medicines and medical devices, including diagnostics. The COMBINE programme will be rolled out over the coming years through seven cross-sector projects. It aims to foster collaboration…
Ben Kemp
December 18, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Notifying BSI of Changes to PMCF and PMPF plans

Critical Communication Notifying BSI of Changes to the Post-market Clinical Follow-up (PMCF) and Post-market Performance Follow-up (PMPF) Plans There is currently a lack of guidance on what constitutes a substantial change to a PMCF/PMPF plan. To address this gap and to provide clarity for our clients, BSI has issued this communication setting out our expectations. For MDR and IVDR devices…
Ben Kemp
December 16, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Commission launches new platform for cross-border medical discussions on rare diseases

Commission launches new platform for cross-border medical discussions on rare diseases The Commission has launched a new IT platform for cross-border medical discussions on rare diseases. The Clinical Patient Management System 2.0 (CPMS 2.0) will support the European Reference Networks (ERNs) in improving the diagnosis and treatment of rare or low prevalence complex diseases across Member States. CPMS 2.0, which…
Ben Kemp
December 12, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

European commissioner for health appointed

Newly appointed European Commissioner for Health and Animal Welfare, Olivér Várhelyi speaks out at the EPSCO (EU member council for Employment, Social Policy, Health and Consumer Affairs) regarding Implementation of the MDR/IVDR. Read more here.
Ben Kemp
December 12, 2024
European Commission Updates Regulatory Affairs NewsletterRegulatory Affairs Newsletter

EU / UK regulation updates – Other legislation

The EU have recast the Liability for defective products directive (EU) 2024/2853, which comes into force 8th December 2024 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024L2853 Note that the maximum timeframe for entitlement for compensation is normally 10 years, but can be up to 25 years (Article 17) – this could impact minimum document retention periods. Additionally, the Recast EU General Safety and Performance Regulation 2023/1828…
Ben Kemp
December 5, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

New legislation and amendments to adapt the EU single market in the event of a crisis

The EC have published new legislation to adapt the EU single market in the event of a crisis. It allows for flexibility in continuing to be able to place products on the market under emergency conditions. Regulation (EU) 2024/2747 of the European Parliament and of the Council of 9 October 2024 establishing a framework of measures related to an internal…
Ben Kemp
December 5, 2024
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