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MDCG 2022-20

MDCG 2022-20 Substantial modification of performance study under Regulation (EU) 2017/746 Disclaimer: This document is an interactive version of the original MDCG document. We will keep it up-to-date. This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of […]

MDCG 2021-11

MDCG 2021-11 Guidance on Implant Card – ‘Device types’ Disclaimer: This document is an interactive version of the original MDCG document. We will keep it up-to-date. This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member […]

MDCG 2021-12

MDCG 2021-12 Rev.1.1 FAQ on the European Medical Device Nomenclature (EMDN) Disclaimer: This document is an interactive version of the original MDCG document. We will keep it up-to-date. This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of […]