Tag: technical file

CE marking

2021-03-02

Medical Device Technical File for MDR Compliance

This article provides guidance on what documents MedTech manufacturers must include in their medical device technical files. The article also shares insights on how a medical device technical file is assessed for MDR compliance.

CE marking

2020-05-27

Technical Documentation for CE marking

This article provides a brief overview of what a technical file is and what it should contain. Special attention will be given to the contents of the technical documentation for respiratory products (e.g. face masks) according to the PPE Regulation 2016/425.