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. Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law. Medical Device Medical Device Coordination Group Document mdcg 2019 -16 rev. 1 Page 2 of 46 Table of Contents 1.

Residual risks (information supplied by the manufacturer) 23.1 g 20.1 g Warnings or precautions (information on the label) 23.2 m 20.2 m Residual risks, contra-indications and any undesirable side-effects, (information in the instructions for use) 23.4 g - Minimum IT requirements (information in the instructions for use) 23.4.ab 20.4.1.ah

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