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MDCG Guidances releases

Latest releases - MDCG Guidances from DOC ROOM EUROPE

Dear Members,

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Here are thereafter and attached in PDF format four MDCG (not binding) guidances released last May and June 2020, regarding subjects you might find of interest.

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May 2020MDCG 2020-11 - 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 Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulation (EU) 920/2013

Also available from DOC ROOM at https://ec.europa.eu/docsroom/docum...

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June 2020 - MDCG 2020-12Guidance on transitional provisions for consultations of authorities on devicesincorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured using TSE susceptible animal tissues

Also available from DOC ROOM at https://ec.europa.eu/docsroom/docum...

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Best regards,

MME Team members

  • MDCG 11 (PDF – 471 kb)

    MDCG 2020-11 - 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 Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulation (EU) 920/2013

  • MDCG 12 - June 2020(PDF – 95.7 kb)

    MDCG 2020-12Guidance on transitional provisions for consultations of authorities on devicesincorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured using TSE susceptible animal tissues

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