Library of documents

The best resources on MDR and IVDR law, always up-to-date.
Simply select the category to be displayed, then view the source of your choice.
Law
Guidance
Useful links
Authorised representative
Clinical evaluation
UK & Switzerland
Standards
MDCG
Competent Authorities
Business associations
Public consultations
Team-NB
Post-market surveillance
Notified Body
Case-law
European Commission
Distributor
Importer
Notice for Manufacturers
Special categories
CE
Other applicable law
Timeline
Manufacturer
Position Papers
UDI
EUDAMED
Law
MDCG
Competent Authorities
Clinical evaluation
Manufacturer
Other applicable law
Timeline
Guidance
European Commission
Useful links
Business associations
Authorised representative
Public consultations
Team-NB
Position Papers
Case-law
Notified Body
Importer
Distributor
Notice for Manufacturers
Special categories
UDI
Post-market surveillance
Standards
EUDAMED
UK & Switzerland
CE