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 monitor...
3 Heinä 202514min
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 mean...
25 Kesä 202511min
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.
19 Joulu 202412min
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 ...
17 Joulu 20247min
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 r...
5 Joulu 20247min
MDCG 2024-15- clinical investigation in the absence of EUDAMED
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 b...
5 Joulu 20245min
AI in Medical Devices Questionnaire by the German NBs Alliance and Team NB
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...
25 Marras 20247min
Gradual Roll-Out of EUDAMED
Join us for an in-depth discussion on the European Commission's latest Q&A document (November 2024) addressing the gradual roll-out of EUDAMED. We explore key deadlines, practical implications for man...
23 Marras 202413min
