MDCG HELPDESK

MDCG Helpdesk – Structured. Searchable. Up to Date.

The MDCG Helpdesk provides a centralized, fully searchable database of all MDCG guidance documents. Clear categorization, update tracking, and an easy-to-navigate design ensure quick access to the latest regulatory information.
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COVID-19 TESTS: Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19

COVID-19 TESTS Rev.0 Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19 Disclaimer: This document is an interactive

Januar 20, 2025

MDCG 2021-27 – Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

MDCG 2021-27 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 Disclaimer: This document is an interactive version

Januar 20, 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

Januar 30, 2025

MDCG 2021-11 – Guidance on Implant Card – Device types

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

Januar 15, 2025