EU Consultation: Medical Devices – Electronic Instructions for Use The European Commission has published for public consultation the draft implementing regulation that would allow instructions for use to be in electronic format for all medical devices intended for exclusive use by healthcare professionals (HCPs). EU Consultation: Medical Devices – Electronic Instructions for Use
14th Notified Body Designated Under EU IVDR Spain-based Notified Body ‘CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS' has been notified as the 14th Notified Body under the IVDR. 14th Notified Body Designated Under EU IVDR
MHRA Guidance – Registration of Reusable or Upclassified Class I Devices and/or Expiring CE Certificates MHRA has issued guidance on registration of medical devices that are reusable or upclassified Class I devices, and/or reliant on expired or expiring CE certificates. Following the EU extending the validity of certain certificates, this guidance sets out what this means for registration and managing registered devices in the MHRA Device Online Registration System (DORS). MHRA Guidance – Registration of Reusable or Upclassified Class I Devices and/or Expiring CE Certificates
Commission Announces Action for Safe and Sustainable e-Commerce Imports The Commission is taking action to tackle risks stemming from low-value imports sold via non-EU online retailers and marketplaces hosting non-EU traders. These actions are part of the Communication on E-Commerce, ‘A Comprehensive EU Toolbox for Safe and Sustainable E-commerce', which the Commission is proposing. Commission Announces Action for Safe and Sustainable e-Commerce Imports
MHRA -Digital Mental Health Technologies Guidance MHRA has issued new guidance to help manufacturers meet UK medical devices regulations and ensure digital mental health technologies are effective, reliable and acceptably safe. MHRA -Digital Mental Health Technologies Guidance
MDCG Q&A Requirements Relating to Notified Bodies – Revision 5 Published The fifth revision of the MDCG 2019-6 on requirements relating to Notified Bodies has been published on the European Commission website. MDCG Q&A Requirements Relating to Notified Bodies – Revision 5 Published
European Health Data Space Webinars The EU Health Policy Team of the European Commission is hosting a series of webinars on the European Health Data Space. European Health Data Space Webinars
UK ePI Task Force Update The UK ePI Task Force is co-led by PAGB, ABPI and BGMA and is working for user-centred, digital-first medicines information. An update from the Task Force has been shared. UK ePI Task Force Update
EMA – Questions & Answers on Article 117 – Fifth Revision Published EMA has updated its guidance on the implementation of EU regulations on medical devices and in vitro diagnostic medical devices to address situations when a declaration of conformity is not available for class I integral medical devices. EMA – Questions & Answers on Article 117 – Fifth Revision Published
Innovative Licensing and Access Pathway (ILAP) Guidance Published MHRA has published ILAP guidance, including how to apply and how to determine whether a medicine or drug-device combination is eligible. Innovative Licensing and Access Pathway (ILAP) Guidance Published
Commission Publishes Updated List of 2025 MDCG Meetings The Commission has published an updated version of planned meeting dates of the MDCG and subgroups for 2025. Commission Publishes Updated List of 2025 MDCG Meetings
European Commission – Implementing Regulation on Procedures for Joint Scientific Consultations on Medical Devices Published in Official Journal The Commission implementing Regulation 20252/117 laying down rules for the application of Regulation (EU) 2021/2282 with regard to the procedures for joint scientific consultations on medical devices and in vitro diagnostic medical devices has been published in the Official Journal of the EU. European Commission – Implementing Regulation on Procedures for Joint Scientific Consultations on Medical Devices Published in Official Journal
