Regulatory framework - cybersecurity requirements for medical devices

We are pleased to present the new guest article by Marius Drabiniok and Fabian Bauer in DeviceMed. The article deals with the highly topical subject of “Regulatory framework - cybersecurity requirements for medical devices”.

Networked medical devices offer enormous benefits for patient care, but are also more vulnerable to cyber attacks. Manufacturers should therefore see security measures not only as a technical requirement, but also as a key legal requirement.

The requirements for the cybersecurity of medical devices arise primarily from the Medical Device Regulation (MDR), the General Data Protection Regulation (GDPR) and, in future, if the medical device contains AI elements, also from the AI Regulation (AI Regulation). The article provides you with a comprehensive overview of these legal principles.

Read the complete guest article at (in German) devicemed.de