Jurisdiction(s):
United Kingdom

Key definition

CE mark definition

What does CE mark mean? The CE mark is the manufacturer’s visible declaration, affixed to many regulated products, that the item meets applicable EU/eea product-safety, health, environmental and other essential requirements, enabling lawful sale and free movement of goods within the EEA. It is defined and governed by EU product legislation (the New Legislative Framework and sector rules, including the medical devices regime). It is not an official “approval” by authorities; it signifies that the required conformity assessment and technical documentation exist, sometimes following assessment by an EU Notified Body. In legal practice, CE marking is central to product compliance, market access, procurement,...

Glossary of UK and EU life sciences regulation (C–D): medicines, medical devices, clinical trials and plant variety rights

Published by a LexisNexis Life Sciences expert

Practice notes

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A–B | E–H | I–N | O–P | Q–V.

ce marking

The CE (Conformité Européene—meaning European Conformity) symbol is compulsory for certain products, including medical devices, to confirm the device meets all relevant medical device regulations before it can be lawfully marketed within the eea.

It:

demonstrates the manufacturer has verified these products satisfy EU safety, health or environmental requirements
signals a product’s conformity with EU legislation
permits the free movement of products across the EEA

In Great Britain (GB) after Brexit, the UKCA mark is the counterpart to the CE mark, available for medical devices placed on the GB market from 1 January 2021, although Northern Ireland continues to require the CE mark under EU legislation. For existing ‘legacy’ devices on the GB market, the CE mark will keep being recognised for varying periods beyond 30 June 2023 under transitional provisions, provided certain conditions are fulfilled. See related terms: conformity assessment, declaration of conformity, Notified Body and UKCA mark...

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Web page updated on 21/05/2026

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