News - January 7, 2020

Guidance on Cybersecurity for Medical Devices

The European Commission published this 06 January its guidance on cybersecurity for Medical Devices. The document, fruit of a long consultation with stakeholders including EUCOPE, provide manufacturers with guidance on how to fulfil all the relevant essential requirements of Annex I to the MDR and IVDR with regard to cybersecurity.

The guidance can be consulted here.