All terms
CE Mark
Mandatory European conformity mark for medical devices placed on the EU market.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
The CE marking on a medical device indicates that the manufacturer declares conformity with applicable EU requirements, including MDR or IVDR, allowing the device to be placed on the market in the European Economic Area.What this means in practice
For most devices above Class I, CE marking requires Notified Body involvement and ongoing surveillance. Brexit added the UKCA mark for Great Britain.Cross-references
Used by
Things that build on this term.
Often confused with
Distinct concept frequently mistaken for this one.
Primary references
3 sourcesLink health: 3 verified· last checked 2026-05-09
European Commission·2FDA·1
- 1
CE MarkingVerifiedEuropean Commissionsingle-market-economy.ec.europa.eu
- 2
FDA - Medical DevicesVerifiedFDAfda.gov
- 3
European Commission - Medical DevicesVerifiedEuropean Commissionhealth.ec.europa.eu
Inline markers like [1] jump to the matching reference above.