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How to verify that medical devices (COVID) Rev.0 How to verify that medical devices and personal protective equipment can be lawfully placed on the EU
Conformity assessment procedures for 3D printing and 3D printed products (Covid) Rev.0 Conformity assessment procedures for 3D printing and 3D printed products to be used
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
Guidance on regulatory requirements for medical face masks Rev.0 Options for supporting production and/or placing on the market of medical face masks in the context
Guidance on medical devices (Covid) Rev.0 Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context Disclaimer:
MDCG 2020-6 Rev.0 Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC A guide for manufacturers and
MDCG 2020-12 Rev.0 Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which
MDCG 2020-11 Rev.0 Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with
SCHEER guidelines Rev.1 Update on the guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic,
MDCG 2022-4 Rev.2 Substantial modification of clinical investigation under Medical Device Regulation Disclaimer: This document is an interactive version of the original MDCG document. We
MDCG 2022-18 ADD.1 MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before
MDCG 2022-18 Rev.0 MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before
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
MDCG 2020-17 Rev.10 Questions and Answers related to MDCG 2020-4 Disclaimer: This document is an interactive version of the original MDCG document. We will keep
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
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
MDCG 2020-9 Rev.0 REGULATORY REQUIREMENTS FOR VENTILATORS AND RELATED ACCESSORIES Disclaimer: This document is an interactive version of the original MDCG document. We will keep
MDCG 2021-25 Regulation (EU) 2017/745 – application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021
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
MDCG 2020-3 Rev.1 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according
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