Transcription of MDCG 2019-16
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MDCG 2019-16
Medical Device Medical Device Coordination Group Document mdcg 2019 -16 rev. 1 Page 1 of 46 mdcg 2019 -16 Guidance on Cybersecurity for medical devices December 2019 July 2020 This document has been endorsed by the Medical Device Coordination Group ( mdcg ) established by Article 103 of Regulation (EU) 2017/745. The mdcg is composed of representatives of all Member States and it is chaired by a representative of the European document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission.
acknowledged that in the field of medical devices, (security) risk has to be reduced to an acceptable level. 2.1. IT Security, Information Security, Operation Security Annex I of the Medical Devices Regulations explicitly sets out the requirement for manufacturers of
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