Last 2020 publications (updated April 08th, 2020)
All MDCG guidances already published shall soon be available in this specific section.
These guidances are not binding guidelines (compared to MDR requirements which are) , but are provided as elements of interpretation / guidelines till real (binding) guidelines are available.
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As for today, you'll find here attached the very last releases from EU "Doc Room" website, which are :
MDCG 2018-1 v3 Guidance on basic UDI-DI and changes to UDI-DI (revision 3 - March 2020)
MDCG 2019-8 v2 Guidance document - Implant Card relating to the application of Art 18 MDR 2017_745 (revision 2 - March 2020)
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MDCG 2020-1 Guidance on Clinical Evaluation _ MDR ____ Performance Evallution IVDR of MD Software
MDCG 2020-2 Guidance on significant changes rgdg the transitional provision under Art. 120 _ devices covered by MMD AIMDD certs (published last March 10th 2020)
MDCG 2019-3 REV 1 - Interpretation of Article 54 (2) b. (published April 06, 2020)
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also available from :
: https://ec.europa.eu/docsroom/docum...
Where you may find all other MDCG (Medical Device Coordination Group) documents published - amongst others - in reverse chronological order.
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Of course, and as ever, we remain at your disposal for any question you may have.
MME Team