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The European Commission has released a draft guidance and reporting template to support the upcoming requirements of the EU AI Act.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...
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...
