Идентификация

Cinical investigations under Medical Device Regulation(Regulation (EU) 2017/745)

Clinical investigation – application form under Medical Device Regulation.

Clinical investigation – Substantial modification of clinical investigation under Medical Device Regulation.

MDCG 2020-10/2 Clinical Investigation Summary Safety Report Form

Performance studies under In Vitro Diagnostic Medical Devices Regulation (IVDR) (Regulation (EU) 2017/746)

Performance study - application/notification form under In Vitro Diagnostic Medical Devices Regulation (IVDR)

Performance study – Substantial modification of performance study under In Vitro Medical Device Regulation

MDCG 2024-4 Performance Study Summary Safety Report Form