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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MDCG 2021-13 rev.1 – Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR

MDCG 2021-13 Rev.1 Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers

April 25, 2025

MDCG 2019-10 rev. 1 – Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC

MDCG 2019-10 Rev.1 Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC Disclaimer: This document is an interactive

April 25, 2025

MDCG 2022-8 – Regulation (EU) 2017/746 – application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC

MDCG 2022-8 Rev.0 Regulation (EU) 2017/746 – application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May

April 25, 2025

MDCG 2019-5 – Registration of legacy devices in EUDAMED

MDCG 2019-5 Rev.0 Registration of legacy devices in EUDAMED Disclaimer: This document is an interactive version of the original MDCG document. We will keep it

April 25, 2025

MDCG 2021-13 rev.1 – Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR

MDCG 2021-13 Rev.1 Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers

April 25, 2025

MDCG 2022-6 – Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR

MDCG 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR Disclaimer: This document is an interactive version of the

April 25, 2025

MDCG 2022-15 – Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD

MDCG 2022-15 Rev.0 Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according

April 25, 2025