Downloads

Downloads

European classification of in vitro diagnostic medical devices according to IVDR 2017/746, examples

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.

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.

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

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


MDSAP - Medical Device Single Audit Program - infographic

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 medical devices in the EU.


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

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


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