GLOSSARYEU

Technical Documentation

The documentation a manufacturer must draw up and keep current to show a device conforms to the EU MDR. Annex II sets the content in six sections, from the device description to verification and validation. Annex III adds post-market surveillance documentation.

Where it is written: Regulation (EU) 2017/745, Article 10(4); Annexes II and III; Article 2 does not define the term
Also called: tech file

Avoid This Mistake

Annex II alone does not complete the file: Article 10(4) requires the elements in Annexes II and III.

All Terms Run the EU MDR Technical Dossier Completeness Diagnostic

Technical Documentation

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