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.
- MDCG 2019-14 Explanatory note on MDR codes
- MDCG 2019-13 Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation
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:
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