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
Understanding the Life Sciences Innovative Manufacturing Fund (LSIMF) Webinar Join us for an exclusive webinar on 30 January with the Office for Life Sciences to delve into the new Life Sciences Innovative Manufacturing Fund (LSIMF). This session is designed to help you navigate the Fund application process from start to finish. Understanding the Life Sciences Innovative Manufacturing Fund (LSIMF) Webinar
Understanding the pEPR Scheme: Implications for Industry and Preparation for PAGB Members PAGB members are invited to an exclusive webinar on Thursday 23 January that will delve into the Extended Producer Responsibility for packaging (pEPR) Scheme. The session will feature a presentation delivered by officials from Defra. Understanding the pEPR Scheme: Implications for Industry and Preparation for PAGB Members
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
MHRA Clinical Investigations Guidance Update The MHRA has updated the guidance on how to notify the MHRA of your intention to carry out a clinical investigation for medical devices, incorporating changes related to clinical investigations involving a site in Northern Ireland. MHRA Clinical Investigations Guidance Update
