“On a duly justified request, Swissmedic may authorise the placing on the market and putting into service of a specific device the use of whi...
Deadline for EUDAMED Registration Is Here!!! … The clock is ticking!
The European Commission has taken a decisive step toward implementing the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR): W...
Help Shape the Future of AI Regulation: Feedback Needed on Serious Incident Reporting
The European Commission has released a draft guidance and reporting template to support the upcoming requirements of the EU AI Act. These docum...
RAPS 2025 – What We Learned About AI, Submissions, and Where Regulatory Heads Next
We are thankful for the opportunity to engage with a large number of attendees at the RAPS Convergence — especially our clients who stopped b...
Eudamed Registrations are Coming — We Can Do the Job for You!
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
Welcome to the MDSS Campus!...
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...
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...
