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.
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#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:
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.
In this episode, Oliver Harris discusses the newly published guidance document MDCG 2024-13 with a regulatory expert. The document, titled 'Regulatory Status of Ethylene Oxide (EtO) Intended for the Sterilisation of Medical Devices - October 2024,' provides guidance on the use of ethylene oxide in the sterilisation process of medical devices under the Medical Device Regulation (MDR).
In this episode of MDRChats, host Oliver Harris interviews medical device compliance expert Dr. Emma Lawson to clarify the differences between Annex 9, Annex 10, and Annex 11 under the Medical Device Regulation (MDR). They delve into the various conformity assessment options, discuss how manufacturers can decide which route to take, and shed light on this often confusing topic for professionals in the industry.
In this episode of MDR Chats, host Oliver Harris interviews an expert about the MDCG 2023-7 guidance document. They discuss the concept of ‘sufficient levels of access’ to data needed to justify claims of equivalence for medical devices, exploring the types of data required, methods of demonstrating access, and the implications for manufacturers. This episode provides essential insights into ensuring compliance with EU medical device regulations and maintaining high standards of safety and performance.
Join host Oliver Harris on MDR Chats as he interviews industry expert Dr. Emily Thompson about the latest revisions in standardisation for medical devices. Stay updated with essential insights on the new MDCG document published in July 2024, including key differences and implications for compliance in the medical device sector. Tune in for expert guidance and practical advice.
Join host Oliver Harris on MDR Chats as he interviews industry expert Dr. Emily Collins about the clinical evaluation of orphan medical devices. Discover the unique challenges and considerations in developing, testing, and regulating devices for rare conditions. Perfect for professionals and enthusiasts in the medical device field.
A risk-based statistical sampling plan for medical devices adjusts sample sizes and testing criteria according to the potential impact of failures, guided by historical data and risk assessments. This method efficiently ensures product safety by matching testing intensity to the severity of possible risks
In this podcast, regulatory experts discuss the extended deadlines under the Medical Device Regulation (MDR), focusing on the transitional periods for various classes of medical devices.
In this episode of MDR Chats, we delve into the intersection of artificial intelligence and medical device regulation under the new EU Artificial Intelligence Act.
This episode is created by chatMDR.eu .
The voices in this podcast are AI-generated.
Better understanding of the PRRC's role, responsibilities, and operational considerations for manufacturers and other economic operators.
The voices in this podcast are AI-generated.
MDRChats is your go-to podcast for the latest insights and updates on Medical Device Regulation, tailored for those with busy schedules.
Our episodes are designed to enhance your understanding of MDR, keeping you informed and ahead in a rapidly evolving field. Subscribe to MDR Chats and effortlessly learn more about Medical Device Regulation.
