Compliance
CE Marking
TL;DR
The conformity mark required to place medical devices (and many other products) on the EU/EEA market.
Affixing the CE mark to a medical device under MDR/IVDR is the manufacturer's declaration that the device meets all applicable General Safety and Performance Requirements (Annex I), is supported by a complete Technical Documentation, has been through the appropriate Notified Body conformity assessment (for everything above Class I non-sterile, non-measuring, non-reusable surgical), and is registered in EUDAMED.
The mark is followed by the NB's four-digit identification number where NB oversight applied (e.g. CE 0123).
Regulatory anchors
- EU MDR Article 20
- EU MDR Annex V
Related terms
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