MDCG launches new guidance, cybersecurity increases under EU MDR and IVDR


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.”