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.
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Yours sincerely Your Team Medical Device International
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