The Eudamed actor and device registrations will become mandatory next year (May?)*. Failing to comply could jeopardize device conformity and di...
Your Voice Matters: Help Shape the Future of EU Medical Device & IVD Regulations!
The European Commission has opened a consultation on the targeted revision of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic ...
Substantial changes to the QMS: Annex IX 2.4
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Electronic Labelling – GDPR Representative required
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...
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 ...
