New regulatory guidance documents on MDR (MDCG 2019-13 to -16)


Dear Ladies and Gentlemen,

We would like to inform you that new MDCG documents on MDR were published in December 2019, which you can view or download below:

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
MDCG 2019-14 Explanatory Note on MDR codes
MDCG 2019-15 Guidance notes for manufacturers of class I medical devices
MDCG 2019-16 Guidance on Cybersecurity for medical devices

If you have any questions, please do not hesitate to contact us, thank you.


Yours sincerely
Your Team
Medical Device International



Langemarckstr. 20
45141 Essen

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