MDRChats-by ChatMDR

The podcast includes MDCG 2025-4 guidance on making medical device software (MDSW) apps available via online platforms — including key definitions, roles under the MDR/IVDR and DSA, and what this means for manufacturers and app stores. It also Includes a sharp legal perspective at the end from Erik Vollebregt (Axon Lawyers).

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!