Latest releases - MDCG Guidances from DOC ROOM EUROPE
Dear Members,
.
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.
.
May 2020 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
Also available from DOC ROOM at https://ec.europa.eu/docsroom/docum...
.
June 2020 - MDCG 2020-12Guidance 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
Also available from DOC ROOM at https://ec.europa.eu/docsroom/docum...
.
Best regards,
MME Team members