EU Medical Devices Regulation (MDR 2017/745)
MDR - Identification, UDI, Registration and EUDAMED (Ch III)

EU Medical Devices Regulation (MDR 2017/745) MDR-Art.21_22_23: Special purposes, systems and procedure packs, parts and components (Articles 21-23)

Article 21 covers devices for special purposes (custom-made, investigational). Article 22 covers systems and procedure packs - combinations of MDs or MDs with non-MD products (system / procedure-pack producer signs a declaration that the components are compatible + bear CE marking + the combination is properly sterilised where applicable). Article 23 covers parts and components placed on the market separately for replacement / repair / refurbishment.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

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