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
MHRA January Board Meeting Documents The agenda and board papers from the MHRA board meeting on 19 January 2024 have been made available. MHRA January Board Meeting Documents
Border Target Operating Model (BTOM) Material The Cabinet Office has published useful material on BTOM. Border Target Operating Model (BTOM) Material
MHRA MedTech Regulatory Reform Webinar MHRA's MedTech Regulatory Reform Webinar will take place on Tuesday 5 March 2024 from 10:30am-12:00pm. The webinar will give information about MHRA’s intentions for the future medical device regulations. MHRA MedTech Regulatory Reform Webinar
MHRA Designates Two New Approved Bodies for Medical Devices The Medicines and Healthcare products Regulatory Agency (MHRA) has designated two new UK Approved Bodies. MHRA Designates Two New Approved Bodies for Medical Devices
EU MDR/IVDR Implementation – Post-Market Surveillance and Vigilance: Device Specific Guidance (DSVG) and Template DSVG and a template have been published on the Commission website. EU MDR/IVDR Implementation – Post-Market Surveillance and Vigilance: Device Specific Guidance (DSVG) and Template
EU MDR/IVDR – Legislative Proposal for Certain IVDs Published The Commission has published a legislative proposal for amending the EU MDR and IVDR as regards the gradual roll-out of Eudamed, an information obligation in case of interruption of supply and the transitional provisions for certain in vitro diagnostic medical devices. EU MDR/IVDR – Legislative Proposal for Certain IVDs Published
