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.

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Supplied as one editable Microsoft Word document in a digital download.

EU MDR assessment and technical documentation

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.

Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.

Practical guide

Read Medical Device Labeling, UDI and CE Marking: Keep Claims Aligned for workflow guidance, a checklist and common mistakes.

Part of a procedure bundle

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