Library of documents

The best resources on EU MDR and IVDR as well as on UK MDR, Swiss Ordonnances, and FDA, always up-to-date.
Simply select the category to be displayed, then view the source of your choice.

EU

Law
Position Papers
Distributor
European Commission
Authorised representative
MDCG
AI & Software
UDI
Competent authorities
Standards
CE
Common specifications
Hospitals
Clinical evaluation & performance evaluation
Importer
Case-law
Notified body
Business associations
Post market surveillance
Public consultations

USA

Law
Databases
Guidance
Classification
Establishment registration & Device listing
510k Premarket notification
Premarket Approval (PMA)
Labelling
Humanitarian Device Exemption (HDE)
Reporting
AI & Software
UDI

Switzerland

Law
Position papers
Guidance
Post market surveillance
Swissdamed
Position papers

UK

Law
AI & Software
Guidance
Post market surveillance
Public consultations