CE Marking

Executive Summary

Many types of medical device sold in the UK or EU markets require CE marking. CE Marking is a symbol used on a product to:

  1. Indicate to governmental officials that the product may be legally placed on the market in their country
  2. Ensure the free movement of the product within the EFTA & European Union single market
  3. Permit the withdrawal of the non-conforming products by customs and enforcement/vigilance authorities.

The Medicines and Healthcare Regulatory Authority is the body in charge of CE Marking in the UK.

This page explains how medical devices are classified, and how CE marking should be used on those devices.