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

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.

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!

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 manufacturers, notified bodies, and other stakeholders, and how early preparation can ease compliance challenges. Whether you're a regulatory professional or a MedTech enthusiast, this episode offers valuable insights and actionable advice to stay ahead of EUDAMED implementation.

In the latest MDR Chats episode, we dive into the new guidance on Article 10a covering manufacturers' obligations for supply interruptions and discontinuations. Highlights: Essential timelines and reporting duties Risk factors impacting patient safety What qualifies as “exceptional circumstances” Join Dr. Emily Bennett and host Oliver Harris to understand what these changes mean for medical device compliance in the EU.

In this episode, Oliver Harris delves into the specific requirements under the MDR as they apply to legacy devices, based on MDCG 2021-25 Rev. 1. He covers essential obligations for manufacturers, authorised representatives, importers, and distributors, including quality management systems, technical documentation, vigilance reporting, and post-market surveillance. Key exemptions for legacy devices are also highlighted, along with important transitional provisions. The discussion emphasizes the balance between regulatory compliance and patient safety during the MDR transition period.