The rapid advances in artificial intelligence and the entry into force of the DigiG are promoting the integration of intelligent medical devices into healthcare by making diagnostics, therapy and assistance systems more efficient and at the same time improving access and reimbursement of digital applications.
With the Cyber Resilience Act (CRA) and the upcoming AI Act, the EU is setting new requirements for IT security and the use of artificial intelligence (AI). These regulations play a central role, particularly in the area of digital healthcare products, which include connected medical devices. The new regulations set standards that require an integrated safety strategy in order to make innovations such as AI in medicine safe and compliant.
Two current German proceedings highlight key MDR interpretation issues: intended purpose of products, risk classification of software and consequences for manufacturers.
