The European Commission has taken a decisive step toward implementing the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR): W...
EU Standards Update
Recently, several standards were added to the list of harmonized European standards for medical devices and IVDs. The European Union (EU) has a long h...
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The European Commission has released a draft guidance and reporting template to support the upcoming requirements of the EU AI Act.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...
Major Changes to UK MHRA Medical Device Registration Fees
Call to Action in the UK database: Save money by deactivating devices that are no longer placed on the UK market. The UK’s Medicines and ...
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...
