44th Notified Body Designated Under EU MDR Swedish-based Notified Body ‘RISE Medical Notified Body AB’ has been notified as the 44th Notified Body under the EU MDR. 44th Notified Body Designated Under EU MDR
IDAP Data Protection and Privacy Information Data protection and privacy information have been added to MHRA's guidance page on the Innovative Devices Access Pathway (IDAP). IDAP Data Protection and Privacy Information
MHRA Chief Executive Dame June Raine to Step Down Dame June Raine, MHRA's Chief Executive, will be stepping down in the Autumn following 5 years in the role. MHRA Chief Executive Dame June Raine to Step Down
Ingredient Challenge – Silicon Dioxide (E 551) Potential ingredient challenge when using food additive E 551 in food supplements, medicines and medical devices. Ingredient Challenge – Silicon Dioxide (E 551)
Smarter Regulation: Regulating for Growth Consultation Response The government response to the consultation, 'Smarter Regulation: Regulating for Growth', was published on 21 February 2024. Smarter Regulation: Regulating for Growth Consultation Response
Commission Consultation on Evaluation of MDR Planned for 2024 The European Commission is planning a targeted evaluation of the MDR and IVDR in 2024, alongside a public consultation in Q3. Commission Consultation on Evaluation of MDR Planned for 2024
Final Eight Selected Technologies in IDAP Pilot Scheme Dr Marc Bailey, MHRA's Chief Science and Innovation Officer, says the IDAP pilot scheme is an "initiative which could be life-changing for many patients". Final Eight Selected Technologies in IDAP Pilot Scheme
First Med Tech Regulations Blog Post Published 2024 is the "year of transparency" says Laura Squire, MHRA's Chief Officer Healthcare, Quality and Access, in the first of a new series of blog posts. First Med Tech Regulations Blog Post Published
Team-AB Launches: The New UK Medical Device Industry Body The new industry body has launched with backing from 11 approved bodies. Team-AB Launches: The New UK Medical Device Industry Body
EUDAMED – Production Release 2.14 EUDAMED Production release 2.14 (Actors registration, UDI/Devices and NBs & Certificates modules) has been successfully deployed. EUDAMED – Production Release 2.14
European Commission Consultation on the Draft Regulation Aiming to Impose a Ban on the Use of BPA in Food Contact Materials EU has open a consultation for the ban of BPA in food contact materials. European Commission Consultation on the Draft Regulation Aiming to Impose a Ban on the Use of BPA in Food Contact Materials
European Commission Notified Bodies Survey on Certifications and Applications The Commission has published results of the 'Notified Bodies Survey on certifications and applications (MDR/IVDR)' on its website. European Commission Notified Bodies Survey on Certifications and Applications
