The technical documentation is prepared based on the general safety and performance requirements set out in Annex I of the medical device’s regulation. The purpose is to document the product’s characteristics based on an assessment of the product’s quality, safety and performance.

In addition, the documentation must include a clinical evaluation. A clinical evaluation is an ongoing process in which clinical data, e.g. from scientific journals and own clinical investigations, are analysed and assessed to establish that the device complies with the general safety and performance requirements.

The clinical investigation is to establish that the risks associated with the use of the device are acceptable when weighed against the expected benefits of the device.

The risk analysis is the main document of the technical documentation. It describes the risk aspects associated with the intended use of the device. The document is to enable an assessment of whether the risks associated with using the device are acceptable when weighed against the benefits that users or patients gain from using the device.

The risk analysis must be continuously maintained and updated in response to changes affecting the product’s risk profile (e.g. changes in production and experience from users).

Declaration of conformity

On fulfilment of the safety and performance requirements and completion of the technical documentation, the manufacturer must date, sign and keep a declaration of conformity to certify that the product complies with the requirements of the executive order.

The manufacturer must keep the declaration of conformity and the technical documentation available for the for a period of at least 10 years after the manufacture of non-implantable and in vitro diagnostics Medical Device Technical File has ceased, and for a period of at least 15 years in the case of implantable devices. The manufacturer is not required to submit the documentation, but must provide it on request.