CE Marking
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
CE marking is the conformity marking a manufacturer affixes to a product to declare that it meets all applicable EU legislation and may be placed on the EU market. For medical devices, CE marking follows a successful conformity assessment — self-assessment for the lowest-risk classes, or Notified Body assessment for all others — and is the visible sign a device may lawfully be sold across the EEA.
CE marking is affixed only after the manufacturer holds a complete technical documentation file, has drawn up an EU Declaration of Conformity, and — where required — has obtained a valid Notified Body certificate. The mark itself must meet minimum size and visibility requirements and, where a Notified Body was involved, must be accompanied by that body’s four-digit identification number.
CE marking under MDR is a stricter regime than the predecessor Medical Device Directive: broader scope (reprocessed single-use devices and certain aesthetic, non-medical products), tightened clinical evidence expectations, and mandatory Unique Device Identification. A device carrying a CE mark issued under the MDD had defined transitional deadlines to migrate to MDR conformity.
- —Declares conformity with applicable EU legislation, enabling EEA market access
- —Follows conformity assessment: self-assessment (lowest risk) or Notified Body (all other classes)
- —Requires technical documentation and an EU Declaration of Conformity before affixing
- —MDR CE marking is broader in scope and evidentiary expectation than the prior MDD regime
EU MDR 2017/745 Article 20 and Annex V; EU IVDR 2017/746 (in vitro diagnostic medical devices)
Frequently asked questions
What is CE Marking?
CE marking is the conformity marking a manufacturer affixes to a product to declare that it meets all applicable EU legislation and may be placed on the EU market. For medical devices, CE marking follows a successful conformity assessment — self-assessment for the lowest-risk classes, or Notified Body assessment for all others — and is the visible sign a device may lawfully be sold across the EEA.
Which regulations cover CE Marking?
EU MDR 2017/745 Article 20 and Annex V; EU IVDR 2017/746 (in vitro diagnostic medical devices)