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.
Start by searching for a topic or document now.

MDCG 2020-10/2 rev.1 – Appendix: Clinical investigation summary safety report form

MDCG 2020-10/2 Rev.1 Appendix: Clinical investigation summary safety report form Disclaimer: This document is an interactive version of the original MDCG document. We will keep

Januar 20, 2025

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 2021-28 – 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

Januar 20, 2025

MDCG 2022-20 – Substantial modification of performance study under Regulation (EU) 2017/746

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

Januar 15, 2025