Medical Device Technical File

What is a medical device technical file?

A medical device technical file is the organized collection of documents used to demonstrate that a device meets applicable regulatory requirements. “Technical file” is a common industry expression; under the EU MDR, the formal term is technical documentation.

Article 10 and Annexes II and III of the EU Medical Device Regulation require this documentation to be clear, organized, readily searchable and unambiguous. It is not merely the submission originally sent to a regulator or notified body. It is a controlled, living body of evidence maintained throughout the device lifecycle.

What belongs in EU MDR technical documentation?

Annex II covers the device description and specification, previous and similar device generations, labels and instructions for use, and design and manufacturing information. It also requires evidence addressing the General Safety and Performance Requirements, benefit-risk analysis, risk management, and product verification and validation.

Clinical and preclinical evidence, software documentation, biocompatibility, electrical safety, sterilization, packaging and shelf-life evidence are included when applicable to the device. Annex III adds the post-market surveillance plan and related post-market documentation.

Is a technical file required for every device class?

Manufacturers of non-custom-made devices must draw up and maintain technical documentation regardless of class. The device class affects the conformity assessment route and the extent of third-party review, but it does not remove the manufacturer’s obligation to hold evidence of conformity.

A lower-risk device can have less complex evidence than a high-risk implant, but its documentation must still be sufficient for the device’s intended purpose, technology and risks.

Is a technical file the same in every market?

No. The underlying evidence often overlaps, but regulators use different formats, terminology and submission structures. An EU MDR technical documentation set is not automatically an FDA 510(k), PMA or another jurisdiction’s dossier. The older GHTF concept of Summary Technical Documentation, or STED, is described in the official GHTF technical document, but national requirements still control.

See our EU MDR consulting overview, FDA 510(k) services and FDA PMA services for market-specific routes.

When must technical documentation be updated?

The file should be reviewed whenever the device, intended purpose, manufacturing process, suppliers, standards, risk assessment, clinical evidence, labeling or post-market findings change. It should remain internally consistent: a changed risk conclusion may require corresponding updates to clinical evaluation, verification evidence, labeling and PMS activities.