Medical devices

Medical devices are those devices that typically act by physical means (including mechanical action, physical barrier, replacement of, or support to, organs or body functions). They are playing an increasingly important part in patient treatment and are currently the subject of changing European regulation. Medical device also raise other difficult regulatory questions such as determining borderline products and dealing with data protection.

Medical devices
SPCs cannot be based on a medical devices certificate
Connected health: Legal aspects of health apps in Germany
Mobile medical apps in Europe
Companion diagnostics