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CATÉGORIE: REGULATORY PATHWAYS
Marquage CE
Le marquage de conformité requis pour les dispositifs médicaux vendus dans l'Espace économique européen, indiquant la conformité aux exigences essentielles de l'EU MDR ou IVDR.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.
WHEN IT APPLIES
CE marking is required to place most medical devices on the EU market under MDR/IVDR, signaling conformity with applicable Union legislation.
PROCESS / STEPS
- Classify device and choose conformity assessment route.
- Implement QMS and compile technical documentation + clinical evaluation.
- Involve a Notified Body when required; obtain certificate(s).
- Draw up EU Declaration of Conformity and affix CE mark (with NB number if applicable).
- Fulfill post-market and economic-operator obligations ongoing.
EXAMPLES
- Class I non-sterile non-measuring devices may self-declare; higher classes need NB review.
RELATED GUIDES & TOOLS
SOURCES
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