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

 
 

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