MDCG2025-6-Interplay Between MDR, IVDR, and the AI Act

MDCG2025-6-Interplay Between MDR, IVDR, and the AI Act

This episode breaks down how the AI Act works alongside MDR and IVDR, how to avoid unnecessary duplication, and what’s required for quality management, technical documentation, and post-market monitoring.

MDCG 2025-4 -making available of MDSW apps on online platforms

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).

Team-NB MDR Certification Consensus

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

MDCG 2019-13 Rev. 1: Understanding the Temporary Sampling Update

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

MDCG 2024-14-Master UDI-DI for Contact Lenses

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.