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IMPORTANT, Important … Guidance for class I manufacturer!

MDCG 2019-15 - Guidance Notes for manufacturers of class I Medical Devices was published last Tuesday, the 17th of December.

And other guidance have been published which are also important.


You may monitor with your quality system this website of the European Union.  It seems that all guidance’s are being published here first. The docsroom.


Most certainly the overall EU website for medical devices provides further information:
Here you may subscribe to newsletter to be informed of changes.  It is our impression that it does not always work or you receive a newsletter rather late.

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