European classification of in vitro diagnostic medical devices according to IVDR 2017/746 - infographics (PDF).

Technical documentation checklist for medical devices according to Annexes II and III of the Medical Device Regulation EU 2017/745 (PDF).

Technical documentation checklist for in vitro diagnostic medical devices according to Annexes II and III of the In Vitro Diagnostic Medical Device Regulation EU 2017/746 (PDF).

Unique device identification (UDI) in the European Union (PDF).

MDSAP - Medical Device Single Audit Program - infographic (PDF).

CE-marking and the regulatory approval process for medical devices in the EU.

CE-marking and the regulatory approval process for in vitro diagnostic medical devices in the EU.