CE Marking Procedure

The CE Marking Procedure leads a medical device team from classification and initial EU MDR assessment through technical documentation, clinical evidence and declaration activities. It also covers the post-market surveillance, clinical follow-up and vigilance work that supports ongoing market placement.

The workflow starts with classification and the applicable conformity-assessment route. It brings together technical documentation, risk and clinical evidence, labeling and the declaration of conformity, then connects market entry to post-market surveillance, clinical follow-up and vigilance. Adapt the route and evidence to the particular device and markets.

The revised procedure addresses Regulation (EU) 2017/745, the EU Medical Device Regulation (MDR).

For controlled label and IFU approvals, use the Label Review and Approval Procedure; for device identifiers and registration records, see the Unique Device Identification Procedure. These procedures are included with this CE marking procedure in the Medical Device Labeling Procedure Bundle.

Supplied as an editable Microsoft Word document as a digital download.

Part of a procedure bundle

This document is also included in Medical Device Labeling Procedure Bundle. Explore the bundle for the related documents.