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
PackUK Launched: the Scheme Administrator for Packaging Extended Producer Responsibility PackUK will implement the UK’s new Extended Producer Responsibility for packaging (pEPR) programme. The EPR SI came into force on 1 January. PackUK Launched: the Scheme Administrator for Packaging Extended Producer Responsibility
Publication of PPWR in Official Journal of the EU The Packaging and Packaging Waste Regulation (PPWR) has been published in the Official Journal of the EU. The regulation will enter into force on 11 February 2025 and will apply from 12 August 2026, with Article 67(5) becoming applicable from 12 February 2029. The PPWR is a step toward harmonised packaging standards across the EU. Publication of PPWR in Official Journal of the EU
Updated Q&A on Practical Aspects of EUDAMED Gradual Roll-Out Implementation The European Commission has updated the Q&A document on the gradual roll-out of EUDAMED, incorporating a flowchart to better illustrate the content. This flowchart specifically addresses the registration of devices in EUDAMED and the impact of vigilance actions. Updated Q&A on Practical Aspects of EUDAMED Gradual Roll-Out Implementation
