CE Marking for Medical Devices — Simplified
CE marking is your passport to the European medical device market — but under EU MDR 2017/745, getting there is more demanding than ever. RABT Global’s CE marking consulting team makes the path clear, manageable, and achievable.
A personalised, no-commitment CE marking roadmap for your specific device and your EU market timeline.
CE marking (Conformité Européenne) is the mandatory European conformity marking that indicates a medical device meets the safety, health, and environmental protection requirements set out in EU MDR 2017/745 (for medical devices) and EU IVDR 2017/746 (for in vitro diagnostics).
In simple terms: without CE marking, your medical device CANNOT legally be sold in the EU, EEA, or countries that accept CE-marked products.
CE marking is not a quality mark — it is a legal obligation and a regulatory declaration by the manufacturer that the device meets all applicable EU regulatory requirements.
CE marking is required for all medical devices placed on the EU/EEA market — whether manufactured inside or outside the EU.
CE Marking Under EU MDR — 5-Step Process
5-STEP CE MARKING PROCESS
Device Classification
Identify your device’s EU MDR risk class (I, IIa, IIb, III) using the 22 classification rules in Annex VIII. Class determines your conformity assessment route and Notified Body requirement.
Conformity Assessment Selection
Choose the appropriate conformity assessment procedure. Class I self-certified devices: manufacturer issues Declaration of Conformity independently. Class IIa, IIb, III: Notified Body involvement required.
Technical Documentation Preparation
Prepare complete technical documentation to EU MDR Annex II and III — including device description, design data, risk management file, clinical evaluation (CER), labeling, and IFU.
Notified Body Assessment (Classes IIa–III)
Submit technical documentation to your selected EU Notified Body for assessment. Support the NB’s technical review and on-site audit. Receive NB certificate.
CE Marking & Declaration of Conformity
Issue your Declaration of Conformity (DoC). Affix CE mark to your device and packaging. Register in EUDAMED. Assign UDI. Begin Post-Market Surveillance programme.
Conformity Assessment Routes — Class I vs Classes IIa, IIb, III
| Device Class | Conformity Assessment Route | Notified Body Required? | Key Technical Requirement |
|---|---|---|---|
| Class I (non-sterile, non-measuring, non-reusable surgical) | Annex IV self-certification | No — manufacturer self-certifies | Technical documentation + Declaration of Conformity |
| Class I sterile / measuring / reusable surgical instruments | Annex IV + specific Annex involvement | Yes — for sterility or measuring function only | Technical documentation + relevant NB conformity assessment |
| Class IIa | Annex IX (QMS) + Annex II/III tech file or Annex X + Annex XI type examination | Yes | QMS assessment + technical documentation / type examination |
| Class IIb | Annex IX (QMS) + Annex II/III tech file or Annex X + Annex XI type examination | Yes | Full technical documentation + QMS + NB certification |
| Class III + Class IIb implantables | Annex IX (design dossier examination) + Annex X + Annex XI | Yes — design examination required | Full technical documentation + design dossier examination by NB |
What is CE Marking for Medical Devices?
CE marking (Conformité Européenne) is the mandatory European conformity marking that indicates a medical device meets the safety, health, and environmental protection requirements set out in EU MDR 2017/745 (for medical devices) and EU IVDR 2017/746 (for in vitro diagnostics).
In simple terms: without CE marking, your medical device CANNOT legally be sold in the EU, EEA, or countries that accept CE-marked products.
CE marking is not a quality mark — it is a legal obligation and a regulatory declaration by the manufacturer that the device meets all applicable EU regulatory requirements.
CE marking is required for all medical devices placed on the EU/EEA market — whether manufactured inside or outside the EU.
CE Marking — Frequently Asked Questions
A: CE marking indicates that the manufacturer has declared, through the conformity assessment process, that the device meets the safety and performance requirements of EU MDR 2017/745. For Class IIa and above, an independent Notified Body has reviewed and certified the technical documentation. CE marking is a regulatory compliance declaration — not a product quality endorsement per se.
A: No. Since 1 January 2021, CE marking is no longer accepted in Great Britain (England, Scotland, Wales) as a standalone authorisation. Devices require either UKCA marking or, under transitional arrangements, CE marking alongside specific MHRA registration. Northern Ireland continues to accept CE-marked devices under the Windsor Framework. RABT Global provides UK MHRA registration services for post-Brexit device compliance.
A: Most Class I (non-sterile, non-measuring) devices do not require a Notified Body — the manufacturer self-certifies. However, Class I sterile devices, Class I devices with a measuring function, and Class I reusable surgical instruments DO require Notified Body involvement for specific aspects of their conformity assessment. RABT Global confirms your NB requirement during device classification.
A: CE marking under EU MDR 2017/745 is significantly more demanding than under the old MDD (93/42/EEC). EU MDR requires stronger clinical evidence (CER to Annex XIV), mandatory EUDAMED registration, UDI implementation, more robust post-market surveillance (PMSR/PSUR), and increased Notified Body scrutiny. Many MDD-certified devices have had to undergo full EU MDR recertification programmes.
A: CE marking is accepted in EEA countries (Norway, Iceland, Liechtenstein) and is used as a reference in several other markets (Switzerland, some Middle Eastern countries, Australia for some product types). However, separate regulatory submissions are required for FDA (USA), MHRA (UK), SFDA (Saudi Arabia), and CDSCO (India). RABT Global coordinates multi-market regulatory programmes using CE marking data wherever possible.
A: You should select an EU-designated Notified Body with the specific device scope (product category, GMDN code) relevant to your device. Current EU MDR-designated NBs include BSI, TÜV SÜD, SGS, Eurofins, Lloyd’s Register, and others. NB capacity is constrained — RABT Global advises on NB selection and manages the application process to maximise your chance of early NB engagement.
A: Yes. RABT Global provides CE marking consulting for medical devices under EU MDR 2017/745 and for in vitro diagnostics under EU IVDR 2017/746. We have separate specialist teams for each regulation and offer integrated programmes for manufacturers with both device and IVD product lines.
A: If you are a non-EU/EEA manufacturer, you are legally required to appoint an EU Authorised Representative (EU AR) before you can CE mark your device. The EU AR is registered in EUDAMED and acts as your regulatory contact point within the EU. RABT Global provides EU Authorised Representative services for non-EU device manufacturers of all device classes.
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