MDRChats-by ChatMDR

A concise guide to the MDR Certification Process, based on the Team-NB Consensus Document, covering pre-application, application, and post-certification phases.

In this episode of MDR Chats, we explore the key update in MDCG 2019-13 Rev. 1: the temporary reduction of sampling requirements from 15% to 5% for MDR Class IIa/IIb and IVDR Class B/C devices. Learn what this means for manufacturers and notified bodies, and how to stay compliant while focusing on high-risk devices. 🎧 Listen now to stay informed! #MDR #IVDR #MedicalDevices #RegulatoryAffairs

In this episode of MDR Chats, we dive into the Master UDI-DI solution for contact lenses, guided by the MDCG 2024-14 document. Hosts Oliver Harris and Dr. Sarah Bennett explore UDI basics, labelling requirements, Eudamed registration, and the compliance timeline. A must-listen for manufacturers and regulatory professionals navigating the future of medical device traceability.

Dive into the latest regulatory updates with host Oliver Harris as he explores MDCG 2024-15, the guidance on publishing clinical investigation reports and summaries in the absence of EUDAMED. Joined by Dr. Eleanor Bennett, a clinical investigations specialist, this episode provides practical insights on compliance, submission processes, confidentiality, and the transition to EUDAMED. Whether you're a sponsor, manufacturer, or regulatory professional, this episode equips you with the knowledge to navigate this critical aspect of the EU Medical Device Regulation (MDR). Stay informed, stay compliant—tune in now!

In this episode of MDR Chats, Dr. Emily Clarke discusses the regulatory challenges and considerations for AI in medical devices. Topics include the roles involved in AI, ensuring device safety for lay users, assessing risks from imbalanced datasets and model bias, and understanding the impact of the social environment on device performance. Tune in for valuable insights on navigating the evolving regulatory landscape for AI-based medical devices. Stay tuned for an upcoming episode with a detailed analysis of the AI questionnaire!