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 r...
30 Okt 20249min
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, aut...
29 Okt 202417min
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 S...
29 Okt 20244min
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 ...
27 Okt 20247min
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 claim...
5 Jul 20249min
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 ...
2 Jul 202412min
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 de...
30 Jun 202421min
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...
4 Mai 20249min
