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    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 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.
    What the regulation says
    The CE mark signifies that a medical device complies with the essential requirements of the applicable European Union regulations, such as the Medical Device Regulation (EU MDR 2017/745) or the In Vitro Diagnostic Medical Device Regulation (EU IVDR 2017/746). This self-declaration of conformity, for most devices, is supported by a Notified Body assessment as outlined in the respective regulations, for example, EU MDR Annex IX.

    What this means in practice

    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.

    Examples

    • A Class I bandage: CE mark alone, no Notified Body number.
    • A Class IIa infusion set: CE 0123 (Notified Body four-digit ID appears).
    • A Class III implant: CE 0123 plus scrutiny procedure conclusions filed in EUDAMED.
    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.

    Frequently asked questions

    It means the manufacturer declares conformity with EU requirements and, where applicable, a Notified Body has verified that declaration. Real-world safety also depends on post-market surveillance, vigilance, and correct use.

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    Primary references

    3 sources
    Link health: 2 verified 1 unchecked· last checked 2026-06-20
    European Commission·1EUR-Lex·2
    1. 1
      CE Marking (European Commission)
      Verified
      European Commissionsingle-market-economy.ec.europa.eu
    2. 2
      MDR Article 20 (CE marking)
      Verified
      EUR-Lexeur-lex.europa.eu
    3. 3
      Regulation (EC) 765/2008 (CE mark rules)
      Unchecked
      EUR-Lexeur-lex.europa.eu

    Inline markers like [1] jump to the matching reference above.