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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

TuV SuD Guide on the interaction between the EU AI Act and the Medical Device legislation

TuV SuD guidance on the interaction between the EU AI Act and the medical devices legislation: https://www.linkedin.com/posts/ugcPost-7354976722951249920-TYVF?utm_source=share&utm_medium=member_desktop&rcm=ACoAAAAeH9EBFpe2TIKx6c7gKShKVeAb46UjtpM
Ben Kemp
August 4, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

For information: EC consultation on delegated regulation on the export and import of hazardous chemicals

Dear members, Please see update below regarding update to the EU PIC (Prior Informed Consent) regulation, which has been update to reflect the inclusion of Dechlorane Plus and UV328 in the Stockholm convention on Persistent Organic Pollutants. The inclusion impacts notification requirements for imports and exports from the EU containing these substances. As the UK is also a signatory to…
Ben Kemp
August 4, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

For information: UV-328 EU OJ Publication 15/7/2025

Dear Members, Update below from MedTech Europe  that the inclusion of UV328 in EU POPs regulation has been published in the OJEC. Note that EU POP regulation applies also in Northern Ireland. I anticipate a further update from HSE as to the inclusion of UV328 under UK POPs regulation. Dear members, I hope you are all well. We are writing…
Ben Kemp
August 4, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveMedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Invitation to Participate in EU4MEDTECH Questionnaire on Innovative and High-Risk MDs and IVDs

On behalf of the EU4MEDTECH project, you are kindly invited to participate in a short questionnaire designed to better understand the current practices, challenges, and digital needs of various stakeholder groups involved in the evaluation of innovative and high-risk medical devices (MDs) and in vitro diagnostic devices (IVDs). This initiative which is part of the EU4MEDTECH project, which aims to…
Ben Kemp
July 30, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Regulation (EU) 2017/746 – mdc medical device certification GmbH (NB 483)

Dear Members, EU NANDO Database updated for Regulation (EU) 2017/746 (EUROPA – European Commission – Growth – Regulatory policy - SMCS ), Regarding the entry for - mdc medical device certification GmbH (NB 483). Total count of available Notified Bodies remains at 18, so this looks to be a change in scope of designation. View article...
Ben Kemp
July 30, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Commission Implementing Decision (EU) 2025/1324 setting up an expert panel for paediatrics and rare diseases

Please be advised that two new EU expert groups for medical devices including IVDs are to be established for Paediatrics and for Rare diseases. These will be established and organised by EMA. Interesting to see where Rare diseases and Paediatrics cross over as most rare diseases are detected, and have most opportunity to be impacted in paediatrics. MedTech Europe are…
Ben Kemp
July 10, 2025
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