What CE marking means for a medical device
The CE mark shows that a device conforms to the EU Medical Device Regulation (EU) 2017/745 and can be placed on the EU market. Under Article 20, devices “considered to be in conformity” with the MDR, other than custom-made or investigational devices, bear the CE marking (MDR Article 20, via Advisera). For most devices above the lowest risk class, the mark is accompanied by the four-digit number of the notified body that assessed conformity.
CE marking is not an FDA clearance. A 510(k) or PMA does not carry over to the EU, and the EU process asks different questions, particularly about clinical evidence and post-market surveillance.
The 2026 context
- Notified body capacity has grown but queues remain. As of February 2026, 52 notified bodies were designated under the MDR, with 32,898 applications and 18,010 certificates (European Commission NB survey).
- EUDAMED is mandatory. Four modules, including actor and device registration, became mandatory on May 28, 2026 (HPRA).
- Simplification is proposed, not adopted. The European Commission proposed targeted changes in December 2025, including replacing five-year recertification with risk-based periodic reviews; the legislative process continues (European Commission).
Step-by-step: CE marking under the MDR
Step 1. Confirm the device is a medical device and classify it
Article 51 states: “Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. Classification shall be carried out in accordance with Annex VIII” (MDR, via Advisera). Use MDCG 2021-24 rev.1, updated in April 2026, for guidance; software follows MDCG 2019-11 rev.1.
Step 2. Appoint an EU authorised representative and a PRRC
A US manufacturer needs an EU-based authorised representative: “the device may only be placed on the Union market if the manufacturer designates a sole authorised representative” (Article 11). Manufacturers must also have “at least one person responsible for regulatory compliance” (Article 15) (EUR-Lex).
Step 3. Implement a compliant QMS
Most manufacturers build on ISO 13485:2016, the same standard FDA’s QMSR now incorporates, and add MDR-specific elements: post-market surveillance, vigilance, UDI, PRRC duties and EUDAMED.
Step 4. Prepare technical documentation
Article 10(4) requires manufacturers to “draw up and keep up to date technical documentation” (EUR-Lex) following Annexes II and III, including a GSPR checklist, risk management file, verification and validation evidence and post-market surveillance documentation.
Step 5. Complete the clinical evaluation
Plan clinical evidence early using Article 61, Annex XIV and MDCG guidance such as MDCG 2020-5 on equivalence. Clinical evidence is often the longest part of a notified body review.
Step 6. Choose the conformity assessment route
| Class | Typical route (Article 52) | Notified body involvement |
|---|---|---|
| Class I | Self-declaration with an EU declaration of conformity | None, except sterile, measuring or reusable surgical aspects |
| Class IIa | Annex IX (QMS) with technical documentation sampling, or Annex XI | Yes |
| Class IIb | Annex IX chapters I and III, with “at least one representative device per generic device group” assessed | Yes |
| Class III | Annex IX, or Annex X type examination with Annex XI | Yes, full technical documentation assessment |
Source: MDR Article 52, via Advisera.
Step 7. Undergo notified body assessment
Expect a QMS audit and technical documentation review, often with several rounds of questions. Team-NB’s 2026 best-practice guidance lists “Insufficient or missing information” and “Lack of Cohesive Structure of Technical Documentation” among the most common causes of delay (Team-NB).
Step 8. Sign the EU declaration of conformity and affix the CE mark
Under Article 19, “The EU declaration of conformity shall state that the requirements specified in this Regulation have been fulfilled” and must contain at least the information in Annex IV (MDR, via Advisera).
Step 9. Assign UDI and register in EUDAMED
Before placing a device on the market, “the manufacturer shall assign to the device… a UDI” (Article 27(3)) (MDR, via Advisera), and register actors and devices in EUDAMED.
Step 10. Maintain conformity after launch
Run post-market surveillance, vigilance and periodic reporting, keep the technical documentation current and prepare for surveillance audits and unannounced notified body visits.
CE marking checklist for US manufacturers
- Device qualification and classification documented with rule rationale
- EU authorised representative appointed; PRRC named
- ISO 13485-based QMS extended for MDR requirements
- Technical documentation per Annexes II and III, with a GSPR checklist linked to evidence
- Clinical evaluation plan and report complete
- Conformity assessment route selected and notified body contracted
- EU declaration of conformity drafted per Annex IV
- UDI assigned; actor and device registered in EUDAMED
- PMS plan, vigilance procedure and PSUR or PMS report process ready
Get your technical file review-ready
The fastest way to shorten a notified body review is to submit a file that is complete, consistent and easy to navigate. AskDona can check technical documentation against MDR Annex II and III requirements or your GSPR checklist, flag missing or inconsistent content, and cite the passage behind every finding.
Run a sample technical documentation assessment on one section of your file. AskDona shows the evidence; your regulatory team decides.
FAQ
What is CE marking for medical devices? The mark showing a device conforms to the EU MDR and can be sold in the EU.
Does FDA clearance give you a CE mark? No. EU conformity assessment is separate from FDA review.
Do all devices need a notified body? No. Most class I devices are self-declared; classes IIa, IIb and III require a notified body.
How long does CE marking take? It varies widely with device class, evidence and notified body capacity; for higher-risk devices, plan for a year or more.
Do US companies need an EU representative? Yes, a sole authorised representative under Article 11.
References
All pages opened and checked by October 13, 2026.
| Source | Type | Date | Used for |
|---|---|---|---|
| EUR-Lex: Regulation (EU) 2017/745 | Regulation | May 5, 2017 | Articles 10, 11, 15 |
| Advisera: MDR Article 20 | Regulation text reproduction | n.d. | CE marking |
| Advisera: MDR Article 51 | Regulation text reproduction | n.d. | Classification |
| Advisera: MDR Article 52 | Regulation text reproduction | n.d. | Conformity routes |
| Advisera: MDR Article 19 | Regulation text reproduction | n.d. | Declaration of conformity |
| Advisera: MDR Article 27 | Regulation text reproduction | n.d. | UDI |
| European Commission: NB survey | Regulator | Jul 2, 2026 | NB statistics |
| HPRA: EUDAMED | Competent authority | Mar 23, 2026 | EUDAMED date |
| European Commission: MDR overview | Regulator | 2026 | Simplification proposal |
| Team-NB: Technical documentation best practice | Notified body association | Apr 21, 2026 | Common delays |