PODCAST · business
MDRChats-by ChatMDR
by 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.
Episodes
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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.
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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…
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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.
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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…
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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…
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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 by Dr. Eleanor Bennett, a clinical investigations specialist, this episode provides practical...
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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 users, assessing risks from imbalanced datasets and model bias, and understanding the impact of...
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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 manufacturers, notified bodies, and other stakeholders, and how early preparation can ease…
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Supply Interruptions & Discontinuations: The New Information Obligation for Medical Devices and IVDs
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”...
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MDR Requirements for Legacy Devices: Insights from the Latest MDCG Revision (MDCG 2021-25 Rev. 1)
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,...
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MDCG 2024-13 - Regulatory status of ethylene oxide
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…
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MDR Conformity Assessment Routes:
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...
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Sufficient levels of access to data needed to justify claims of equivalence
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...
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Guidance on Standardisation for Medical Devices - Rev 1, Published July 2024
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…
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Clinical evaluation of orphan medical devices
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...
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Risk-Based Statistical Sampling Plan
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...
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A Deep Dive into Medical Device Deadlines
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.
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The Significance of the EU AI Act for 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.
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Person Responsible for Regulatory Compliance, PRRC
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.
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MDRChats | Official Trailer
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...
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ABOUT THIS SHOW
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.
HOSTED BY
ChatMDR
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Frequently Asked Questions
How many episodes does MDRChats-by ChatMDR have?
MDRChats-by ChatMDR currently has 20 episodes available on PodParley. New episodes are automatically indexed when they're published to the podcast feed.
What is MDRChats-by ChatMDR about?
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...
How often does MDRChats-by ChatMDR release new episodes?
MDRChats-by ChatMDR has 20 episodes. Check the episode list to see recent publication dates and frequency.
Where can I listen to MDRChats-by ChatMDR?
You can listen to MDRChats-by ChatMDR on PodParley by clicking any episode. We provide an embedded audio player for direct listening, and you can also subscribe via your preferred podcast app using the RSS feed.
Who hosts MDRChats-by ChatMDR?
MDRChats-by ChatMDR is created and hosted by ChatMDR.
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