The German Medical Devices Operator Ordinance (MPBetreibV) has recently been updated to include stringent cybersecurity requirements for all network-connected devices operating in German hospitals.
Key Updates to §4a
The new §4a specifically targets the "interoperability and secure operation" of medical devices. Operators must now ensure that any connected device has a documented cybersecurity lifecycle that is compatible with the hospital's IT infrastructure.
What this means for Manufacturers
If you sell devices in Germany, you are now required to provide:
- A Software Bill of Materials (SBOM) in a standardized machine-readable format.
- Documented patch management procedures with clear SLAs for critical vulnerabilities.
- Defined interfaces for security logging and monitoring by hospital IT.
Failure to comply can result in devices being barred from use in public health institutions, regardless of their CE mark status.
Author
We are thrilled to have Shubham Kumar Singh share their opinion on our blog. As a valued member of the Medbash team, Shubham Kumar Singh brings a wealth of expertise and insights to our readers. Their contributions help us stay at the forefront of medical device compliance and innovation.
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