The CE marking on a medical device is the manufacturer's declaration under Article 20 of MDR (or Article 18 of IVDR) that the device meets all applicable EU requirements, including the General Safety and Performance Requirements of Annex I, and has undergone the applicable conformity assessment procedure. It permits placing the device on the market throughout the European Economic Area, Switzerland (via MRA), and Turkey.

Why it matters

For Class I (non-sterile, non-measuring, non-reusable surgical) devices, the manufacturer self-certifies. For all higher classes, a Notified Body is involved and its four-digit identification number appears next to the CE mark (e.g. CE 0123 for TUV SUD). CE marking must be affixed visibly, legibly, and indelibly to the device and packaging, and reproduced in the IFU. Brexit split the market: Great Britain requires UKCA (or continues to accept CE until 30 June 2030 under the UK MDR (Amendment) Regulations 2023), while Northern Ireland continues to use CE under the Windsor Framework. The EU Declaration of Conformity (Annex IV of MDR) must accompany the device and reference the applicable regulation, the Notified Body if involved, and harmonized standards used.

Common pitfalls

•Affixing CE mark before the Notified Body issues the certificate for Class IIa+ - illegal placing on the market.
•Using the CE mark for a device not covered by the Notified Body scope or for indications outside the certificate.
•Missing the mandatory dimensions (minimum 5 mm height) or altering the proportions specified in Annex V of Regulation 765/2008.
•Assuming CE for a medical device also covers Machinery Directive, EMC Directive, or RED requirements - each applicable EU legislation must be assessed separately and cited in the DoC.

Sources

CE Marking (European Commission) · European Commission
MDR Article 20 (CE marking) · EUR-Lex
Regulation (EC) 765/2008 (CE mark rules) · EUR-Lex

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Software classification - SaMD vs SiMD, Locked vs adaptive AI.
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