
MDRChats-by ChatMDR
Podcast door ChatMDR
MDRChats is your go-to audio destination for simplifying the regulatory landscape for medical device professionals, supported by ChatMDR (https://chatmdr.eu/). Information on the latest updates, insights, and guidance documents; all designed to keep you informed and ahead in your field. Whether you're on your commute, taking a break, or just prefer listening over reading, MDRChats is designed to fit seamlessly into your day. Our episodes transform your available moments into productive insights on regulatory changes.
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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.

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.
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