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
Team-NB Releases High-Level Position on the Regulatory Framework for the Medical Devices Sector Team NB, has published its high level position on the regulatory framework for the medical devices sector. Team-NB Releases High-Level Position on the Regulatory Framework for the Medical Devices Sector
MDCG 2024-15 – Guidance on Publication of Clinical Investigation Reports and Summaries in Absence of EUDAMED The Medical Device Coordination Group (MDCG) 2024-15 Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED has been published. MDCG 2024-15 – Guidance on Publication of Clinical Investigation Reports and Summaries in Absence of EUDAMED
MHRA AI Airlock Pilot Scheme Technologies MHRA has published the first five technologies as part of the AI Airlock sandbox. MHRA AI Airlock Pilot Scheme Technologies
European Commission Webinar on Packaging and Packaging Waste Regulation On 16 December, the European Commission is hosting a webinar on the Packaging and Packaging Waste Regulation (PPWR). European Commission Webinar on Packaging and Packaging Waste Regulation
Team NB Releases Questionnaire on Artificial Intelligence in Medical Devices Team-NB has published a questionnaire on artificial intelligence in medical devices. Team NB Releases Questionnaire on Artificial Intelligence in Medical Devices
MHRA Windsor Framework and Established Medicines Webinar Recordings MHRA has published recordings on recent webinars on the topics of Windsor Framework and Established Medicines. MHRA Windsor Framework and Established Medicines Webinar Recordings
