MDCG HELPDESK

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Economic Operators
Economic Operators
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Regulation/Directive
Regulation/Directive

2020-10/1 rev.1

MDCG 2020-10/1 Rev.1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745 Disclaimer: This document is an interactive version of the

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2020-10/2 rev.1

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

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COVID-19 TESTS

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

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Conformity assessment procedures

Conformity assessment procedures Rev.0 Conformity assessment procedures for protective equipment Disclaimer: This document is an interactive version of the original MDCG document. We will keep

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2020-1

MDCG 2020-1 Rev.0 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software Disclaimer: This document is an interactive version of the

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2020-2 rev.1

MDCG 2020-2 Rev.1 Class I Transitional provisions under Article 120 (3 and 4) – (MDR) Disclaimer: This document is an interactive version of the original

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2020-15

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

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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

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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

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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

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