Medical Devices: List of UK Approved Bodies Eurofins E&E CML Limited has been added to the list of UK approved bodies for medical devices. Medical Devices: List of UK Approved Bodies
16th Notified Body Designated Under EU IVDR Belgium based Notified Body ‘SGS Belgium NV’ has become the 16th Notified Body under the EU IVDR. 16th Notified Body Designated Under EU IVDR
15th Notified Body Designated Under EU IVDR Italy based Notified Body ‘IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.’ has been notified as the 15th Notified Body under the EU IVDR. 15th Notified Body Designated Under EU IVDR
Team-NB Position Paper on European Artificial Intelligence Act Team-NB has published a Position Paper on the European Artificial Intelligence Act. Team-NB Position Paper on European Artificial Intelligence Act
MHRA Clinical investigations Guidance Update The MHRA has updated its guidance on notifying the agency of an intention to conduct a clinical investigation for medical devices. The revised guidance now includes a dedicated document specifically for manufacturers. MHRA Clinical investigations Guidance Update
UK Clinical Trials Regulations Signed into Law New regulations for running clinical trials in the UK have now been signed into law. A 12-month roll-out began on 11 April to deliver a significant update to UK clinical trials regulation, with the aim of strengthening patient safety, accelerating approvals, enabling innovation and helping more people benefit from taking part in vital research. UK Clinical Trials Regulations Signed into Law
Revised Team-NB Best Practice Guidance – Submission of Technical Documentation Team-NB has published a revised version of its “Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745”. Revised Team-NB Best Practice Guidance – Submission of Technical Documentation
DBT – Request for Input on Potential UK Measures in Response to US Tariffs The Department for Business and Trade (DBT) is seeking input from stakeholders on potential UK measures in response to recent US tariff announcements. DBT – Request for Input on Potential UK Measures in Response to US Tariffs
EU Life Sciences Strategy – Call for Evidence The European Commission has opened a Call for Evidence on the EU Life Sciences Strategy, closing 17 April 2025. EU Life Sciences Strategy – Call for Evidence
MHRA Publishes Updated Statutory Fees for Medicines (2025–2027) The MHRA has published updated statutory fees for medicines, following a public consultation and response process. MHRA Publishes Updated Statutory Fees for Medicines (2025–2027)
MHRA Guidance on Exceptional Use Authorisations The MHRA has published a guidance on how to apply for an exceptional use authorisation to place medical devices on the UK market. MHRA Guidance on Exceptional Use Authorisations
DHSC Public Appointments: October 2024 – March 2025 The Department of Health and Social Care (DHSC) has announced its non-executive appointments for the period from October 2024 to March 2025. DHSC Public Appointments: October 2024 – March 2025
