The Regulation (EU) 2021/2226 of electronic instruction for use (eIFU) in Article 7 refers to the websites where users can view their eIFU docu...
Navigating the EU AI Act: What Medical Device & In Vitro Diagnostic Manufacturers Need to Know
The European Artificial Intelligence Act (AI Act) aims to create a comprehensive legal framework for artificial intelligence within the European Union...
Sponsor and Legal Representative vs Authorized Representative
This educational video explains the roles and responsibilities of the Sponsor and Legal Representative under Article 62. It also highlights how...
FDA Quality Management System Regulation
The transition period for FDA’s Quality Management System Regulation (QMSR), which replaces 21 CFR Part 820, will end on February 2, 2026, align...
New guidance on the PMS requirements has now been published by the MHRA
New MORE Guidance on implementing the changing data requirements for medical device reporting. The MHRA has released a new guidance to support medical...
New list of IMDRF Codes Published
The International Medical Device Regulators Forum (IMDRF) has released an updated version of its “Terminologies for Categorized Adverse Event Re...
New MIR Form (Version 7.3.1)
The European Commission has published the updated Manufacturer Incident Report (MIR) PDF form, version 7.3.1, which will become mandatory on November ...
June 2025 Deadline: Stricter UK Medical Device PMS Regulations Published
MDSS is pleased to share that Statutory Instrument 2024 No. 1368 – The Medical Devices (Post-market Surveillance Requirements) Regulations 2024 has ...
Swiss Federal Council to recognize FDA approvals / clearances — A game-changer for Medtech access!
In a landmark move, the Swiss Federal Council has decided to recognize approvals from the U.S. Food and Drug Administration (FDA), ensuring continued...
Pilot coordinated assessment for Clinical Investigation!
On March 11, 2025 the Secretariat for the Clinical Investigation / Performance Study coordinated assessment held a webinar to discuss the pilot coordi...
