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:
- Basic Cybersecurity Concepts
- Secure Design and Manufacture . . .
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