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
European Commission Revises Application Form for Notified Body Designation Under MDR/IVDR The European Commission has published a revision of the application form to be submitted by a conformity assessment body when applying for designation as a notified body or by a notified body when extending their scope of designation under MDR/IVDR. European Commission Revises Application Form for Notified Body Designation Under MDR/IVDR
New legislation on Post-market Surveillance for Medical Devices in Great Britain The MHRA has issue a suite of Guidance on the new Medical Devices Post-market Surveillance requirements. New legislation on Post-market Surveillance for Medical Devices in Great Britain
MHRA – Patient Involvement Strategy: An Assessment of Progress MHRA has published an assessment of progress made in delivering the Patient Involvement Strategy between October 2021 - January 2025. MHRA – Patient Involvement Strategy: An Assessment of Progress
New EU Rules on Health Technology Assessment On 12 January, the Regulation on Health Technology Assessment (HTA) became applicable in the EU. The new rules create an EU framework for the assessment of health technologies, such as medicines and medical devices, by fostering collaboration and coordination between EU Member States. New EU Rules on Health Technology Assessment
AESGP Webinar: Navigating the AI Act for Non-Prescription Medicines and Self-Care Medical Device Manufacturers – Challenges and Opportunities Join AESGP's webinar, "Applicability of AI Act for Non-Prescription Medicines and Self-Care Medical Devices Manufacturers: Challenges and Opportunities," on Thursday, 23 January, to explore the implications, challenges, and opportunities of the AI Act for the self-care sector. AESGP Webinar: Navigating the AI Act for Non-Prescription Medicines and Self-Care Medical Device Manufacturers – Challenges and Opportunities
Unlocking the Potential of UK HealthTech: Event on 15 January 2025 An event for industry stakeholders, ‘Unlocking the potential of UK HealthTech - insights and recommendations from a breakthrough review of the sector’, is taking place on Wednesday 15 January 2025 between 12.00 – 13.00. Unlocking the Potential of UK HealthTech: Event on 15 January 2025
Safety and Security Declarations for Goods Imported from the EU to Great Britain Starting January 2025, Safety and Security declarations will be mandatory for all imports from the EU into GB.. Safety and Security Declarations for Goods Imported from the EU to Great Britain
Defra – pEPR Recyclability Assessment Methodology & Webinar The Extended Producer Responsibility for packaging (pEPR) Recyclability Assessment Methodology (RAM) has been published by Defra and the pEPR Scheme Administrator. Defra is organising a webinar on 16 January 2025 (2-4pm) on the Base Fees and the RAM methodology and approach to reporting. Defra – pEPR Recyclability Assessment Methodology & Webinar
