--- title: "CE Mark, Definition | MedTech Terms" description: "Mandatory European conformity mark for medical devices placed on the EU market. Plain-English Regulatory definition for MedTech teams, with examples and related" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ce-mark#term", "name": "CE Mark", "description": "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. 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The UK currently continues to recognize CE-marked devices under the Medical Devices (Amendment) Regulations 2024, with a phased transition timeline." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. CE Mark [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets) # CE Mark Mandatory European conformity mark for medical devices placed on the EU market. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition The CE marking on a medical device is the manufacturer's declaration under Article 20 of [MDR](/terms/mdr-reporting) (or Article 18 of [IVDR](/terms/ivdr)) that the device meets all applicable EU requirements, including the [General Safety and Performance Requirements](/terms/gspr) 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](/terms/mdr-reporting) 2017/745) or the In Vitro Diagnostic Medical Device Regulation (EU [IVDR](/terms/ivdr) 2017/746). This self-declaration of conformity, for most devices, is supported by a [Notified Body](/terms/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](/terms/notified-body) is involved and its four-digit identification number appears next to the CE mark (e.g. CE 0123 for TUV [SUD](/terms/single-use-device)). CE marking must be affixed visibly, legibly, and indelibly to the device and packaging, and reproduced in the [IFU](/terms/ifu). Brexit split the market: Great Britain requires UKCA (or continues to accept CE until 30 June 2030 under the UK [MDR](/terms/mdr-reporting) (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 Does CE mark mean the device is safe? It means the manufacturer declares conformity with EU requirements and, where applicable, a [Notified Body](/terms/notified-body) has verified that declaration. Real-world safety also depends on [post-market surveillance](/terms/post-market-surveillance), vigilance, and correct use. How long is a CE certificate valid? Can I CE mark a device made outside the EU? Is UKCA the same as CE? ## Cross-references ### Used by Things that build on this term. - [ EU Medical Device Regulation(MDR) ](/terms/mdr) ### Often confused with Distinct concept frequently mistaken for this one. - [ MHRA / UKCA Marking(MHRA / UKCA) UKCA replaces CE for the GB market. ](/terms/mhra-ukca) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory Notified Body(NB) EU-designated organization that assesses conformity of medical devices under MDR and IVDR. ](/terms/notified-body)[ Regulatory EU In Vitro Diagnostic Regulation(IVDR) Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU. ](/terms/ivdr)[ Regulatory EUDAMED European Database on Medical Devices. ](/terms/eudamed)[ Regulatory EU Medical Device Regulation(MDR) Regulation (EU) 2017/745 governing medical devices in the European Union. ](/terms/mdr) ### EU MDR Essentials · From this learning path [ Post-Market Field Safety Corrective Action(FSCA) Action taken to reduce a risk of serious deterioration in health associated with a device. ](/terms/fsca?from=eu-mdr-essentials)[ Post-Market Medical Device Vigilance Reporting and management of serious incidents and field safety corrective actions. ](/terms/vigilance?from=eu-mdr-essentials)[ Regulatory Unique Device Identification(UDI) System for adequate identification of medical devices through distribution and use. ](/terms/udi?from=eu-mdr-essentials)[ Post-Market Periodic Safety Update Report(PSUR) Periodic EU MDR/IVDR report summarizing post-market surveillance findings. ](/terms/psur?from=eu-mdr-essentials) ### IVDR Essentials · From this learning path [ Market Segments Companion Diagnostic(CDx) IVD that identifies patients who will benefit from a specific drug. Adjacent lesson ](/terms/companion-diagnostic?from=ivdr-essentials)[ Regulatory General Safety and Performance Requirements(GSPRs) Annex I requirements under EU MDR/IVDR that every device must demonstrate it meets. ](/terms/gspr?from=ivdr-essentials)[ Regulatory IVDR Risk Classes A–D EU IVDR's risk-based classification: Class A (lowest) to Class D (highest). ](/terms/ivdr-classes?from=ivdr-essentials)[ Clinical & Trials Clinical Evaluation Plan(CEP) EU MDR document that defines the scope, methods, and acceptance criteria for the clinical evaluation that will be reported in the Clinical Evaluation Report (CER). ](/terms/clinical-evaluation-plan?from=ivdr-essentials) Cited by Where this term appears across MedTech Terms. Learning paths (2) - [EU MDR Essentials](/paths/eu-mdr-essentials)Lesson 3 of 9 - [IVDR Essentials](/paths/ivdr-essentials)Lesson 4 of 13 Ecosystems (2) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 2 verified 1 unchecked · last checked 2026-06-20 European Commission· 1 EUR-Lex· 2 1. [1 CE Marking (European Commission) Verified European Commission · single-market-economy.ec.europa.eu ](https://single-market-economy.ec.europa.eu/single-market/ce-marking_en) 2. [2 MDR Article 20 (CE marking) Verified EUR-Lex · eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2017/745/oj) 3. [3 Regulation (EC) 765/2008 (CE mark rules) Unchecked EUR-Lex · eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2008/765/oj) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Regulatory Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=ce-mark) Learn in 60 seconds Card Lesson Quiz Mandatory European conformity mark for medical devices placed on the EU market. - · 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). Remember this Watch out: Affixing CE mark before the Notified Body issues the certificate for Class IIa+ - illegal placing on the market. Related terms - [EU Medical Device Regulation(MDR) ](/terms/mdr) - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) - [Notified Body(NB) ](/terms/notified-body) - [EUDAMED ](/terms/eudamed) - [MHRA / UKCA Marking(MHRA / UKCA) ](/terms/mhra-ukca) You may also need Auto-suggested from Regulatory and shared keywords. - [AI Act Conformity Assessment (Medical Devices) ](/terms/ai-act-conformity-assessment) - [General Safety and Performance Requirements(GSPRs) ](/terms/gspr) - [Post-Market Surveillance Plan (IVDR) ](/terms/ivdr-pms-plan) - [General Safety and Performance Requirements (IVDR)(GSPR) ](/terms/ivdr-gspr) - [High-Risk AI System (EU AI Act) ](/terms/ai-act-high-risk-system) - [Post-Market Performance Follow-Up (IVDR)(PMPF) ](/terms/ivdr-pmpf) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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