The Medical Device Coordination Group (MDCG) has launched new guidance that targets device cybersecurity norms which will help the device manufacturers fulfill various cybersecurity norms that pose a threat to the stability of the EU Medical Devices Regulation MDR and In Vitro Diagnostic Regulation IVDR as per its norms in Annex-I.

The 47- paged guidance explains the post-market and pre-market requirements to help companies ensure an adequate balance between the benefits and risks during all of a device’s possible operation modes. MDCG notes that manufacturers should foresee or evaluate the potential exploitation of cyber vulnerabilities that may be a result of “reasonably foreseeable misuse.”