Publications : Datas

MDCG 2020-12 : Guidance on transitional provisions for consultations of authorities on devices incorporating 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 – June 2020

  Theme Specific additional procedures Target audience Notified Bodies, Manufacturers Products concerned ·       Devices containing a substance which may be considered a medicinal product and which has action ancillary to that of the device ·       Devices...

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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 – April 2020

Theme Designation and monitoring of Notified Bodies (NB) Target audience Authority responsible for Notified Bodies Products concerned MD, AIMD Documents mentioned Commission Implementing Regulation (EU) 2020/666 of 18 May 2020 amending Implementing Regulation (EU) No...

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