MDCG adopts IMDRF guidance on device cybersecurity

The EU Medical Device Coordination Group (MDCG) has issued new guidance to help manufacturers fulfill the cybersecurity requirements in Annex I of the Medical Devices Regulation (MDR, 2017/745) and In Vitro Diagnostic Regulation (IVDR, 2017/746).

The 47-page guidance, which aligns with the cybersecurity guidance published by the International Medical Device Regulators Forum (IMDRF), explains both premarket and postmarket requirements to help companies ensure an adequate balance between benefits and risks during all device operation modes. MDCG notes that manufacturers should include evaluation of the potential exploitation of cyber vulnerabilities that may be a result of “reasonably foreseeable misuse.”

Copies of the guidance are available from here.