Clarification Archive - MDCG Helpdesk

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

Januar 20, 2025

MDCG 2018-6 – Clarifications of UDI related responsibilities in relation to article 16

MDCG 2018-6 Rev.0 Clarifications of UDI related responsibilities in relation to Article 16 of the Medical Device Regulation (EU) 2017/745 and the In-Vitro Diagnostic Medical

Januar 20, 2025

MDCG 2021-22 rev.1 – Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746

MDCG 2021-22 Rev.1 Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the

Januar 20, 2025

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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 2018-6 – Clarifications of UDI related responsibilities in relation to article 16

MDCG 2021-22 rev.1 – Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746