MDCG Guidance on cybersecurity for MD

The European Commission published today a new MDCG Guidance, which is 16th in line, and has the purpose to help medical device manufacturers and other actors to fulfill cybersecurity requirements in accordance with the Annex I of the EU MDR/IVDR.

47 pages long Guidance document is divided in several sections and two Annexes that address both pre-market and post-market aspects: