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
EU – COMBINE Program for Clinical Trials and Medical Devices Member State authorities have approved a new strategy for the COMBINE programme. EU – COMBINE Program for Clinical Trials and Medical Devices
Implementation of Medical Devices Future Regime – Revised MHRA Regulatory Roadmap The MHRA has published a revised roadmap, providing a further update on the intended timelines to implement the future medical device regulations. Implementation of Medical Devices Future Regime – Revised MHRA Regulatory Roadmap
Team-NB Consensus Document on MDR Certification Process Team NB -The European Association of Medical Devices Notified Bodies, has released a Consensus document on MDR Certification Process. Team-NB Consensus Document on MDR Certification Process
Study on Availability of MDs – Second Survey Launched A second survey for data collection from manufacturers and other economic operators in the framework of the “Study supporting the monitoring of availability of medical devices on the EU market” has been launched. Study on Availability of MDs – Second Survey Launched
Post-Market Surveillance Requirements Legislation In Place The government has now put in place legislation relating to the Post-market surveillance requirements for medical devices in use in Great Britain. Post-Market Surveillance Requirements Legislation In Place
MHRA MedTech Blog and Revised Roadmap MHRA has published the December edition of the MedTech blog. MHRA MedTech Blog and Revised Roadmap
EU Rules on Medical Devices – Targeted Evaluation The European Commission has launched a consultation on the effectiveness of the EU regulations on medical devices and in vitro diagnostic medical devices. The consultation opened on 12 December 2024 and the deadline to respond is 21 March 2025. EU Rules on Medical Devices – Targeted Evaluation
New Manufacturer Information Form Published for Reporting Supply Interruptions or Discontinuations of Medical Devices and In Vitro Diagnostic Devices The MDCG 2024 – 16 manufacturer information form on interruption or discontinuation of supply of certain medical devices and certain in vitro diagnostic medical devices and its annex has been published. New Manufacturer Information Form Published for Reporting Supply Interruptions or Discontinuations of Medical Devices and In Vitro Diagnostic Devices
