A medical device always consists of the medical appliance AND its product file. Regardless of the device classification, whether you want to launch a class I, IIa, IIb, or III medical device or in vitro diagnostics: You must provide technical documentation in any case.

The technical documentation includes all details about the medical device. In addition to the actual technical product information, it also includes all specifications about development, manufacturing, verification and validation, as well as application of the product.

By means of the technical documentation, you as the manufacturer establish proof that your medical device conforms to the underlying regulations of the individual countries. Furthermore, it confirms compliance with the basic requirements for European CE marking. It is the prerequisite for the approval of a device in the relevant target country. Across the entire lifecycle of the device, but at least five years after the last device’s manufacture (15 years for implants), the technical documentation must be available to the supervisory authorities for inspection.