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MDCG 2021-28 – Substantial modification of clinical investigation under Medical Device Regulation

MDCG 2021-28 Substantial modification of clinical investigation under Medical Device Regulation Disclaimer: This document is an interactive version of the original MDCG document. We will

April 25, 2025

MDCG 2021-24 – Guidance on classification of medical devices

MDCG 2021-24 Guidance on classification of medical devices Disclaimer: This document is an interactive version of the original MDCG document. We will keep it up-to-date.

April 25, 2025

MDCG 2020-15 – MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States

MDCG 2021-15 MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States

April 25, 2025

MDCG 2021-12 rev.1 – FAQ on the European Medical Device Nomenclature (EMDN)

MDCG 2021-12 Rev.1 FAQ on the European Medical Device Nomenclature (EMDN) Disclaimer: This document is an interactive version of the original MDCG document. We will

April 25, 2025

MDCG HELPDESK

MDCG Helpdesk – Structured. Searchable. Up to Date.

MDCG 2021-28 – Substantial modification of clinical investigation under Medical Device Regulation

MDCG 2021-24 – Guidance on classification of medical devices

MDCG 2020-15 – MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States

MDCG 2021-12 rev.1 – FAQ on the European Medical Device Nomenclature (EMDN)