CE marking of a medical device: the steps under the MDR

CE marking is a medical device's passport to the European Union market. It is not obtained from an administration: the manufacturer affixes it, after demonstrating conformity with Regulation (EU) 2017/745 through the procedure its class requires. Here are the steps, in the order they come.

1. Qualify the product

Is the product a medical device within the meaning of MDR Article 2(1)? It is if it has a medical purpose (diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, injury or disability…) and its principal action is not achieved by pharmacological, immunological or metabolic means. For software, MDCG 2019-11 guides the reasoning; for borderline cases, the Commission's manual on borderline products.

2. Determine the class

The class (I, IIa, IIb or III) follows from the 22 rules of Annex VIII. It drives what comes next. Our guide on medical device classification presents them one by one.

3. Choose the conformity assessment procedure

Article 52 refers to Annexes IX to XI depending on the class:

• Class I: manufacturer's self-declaration, except sterile, measuring or reusable surgical devices, for which a notified body assesses those aspects;
• Class IIa: quality system (Annex IX) or product verification (Annex XI);
• Class IIb: Annex IX, or type examination (Annex X) with Annex XI;
• Class III: Annex IX, with technical documentation assessed for each device, or Annexes X and XI.

4. Set up the quality management system

Article 10(9) requires a quality system proportionate to the device class and type. The de facto reference is ISO 13485:2016, whose harmonised version gives presumption of conformity. It covers in particular the regulatory compliance strategy, risk management, clinical evaluation, post-market surveillance and change control.

5. Build the technical documentation

Annexes II and III: description, design and manufacturing, conformity with the Annex I general requirements, risk management under ISO 14971, verification and validation, clinical evaluation (Article 61, Annex XIV) and post-market surveillance plan. Our guide on technical documentation details the content.

6. Appoint the PRRC and register in EUDAMED

• Appoint a PRRC meeting the conditions of Article 15.
• Register the company in the EUDAMED Actor module to obtain its SRN, mandatory since 28 May 2026.
• Assign the device's Basic UDI-DI, before any notified body application.
• If the manufacturer is established outside the EU, designate an authorised representative (Article 11).

7. Go through notified body assessment

For the classes concerned, choose a notified body designated for your type of device (scope checkable in NANDO and EUDAMED), then apply. The assessment usually includes a quality system audit and a technical documentation assessment, on a sample basis or device by device depending on the class. For certain class III devices, an expert panel is consulted on the clinical evaluation (Article 54). At the end, the notified body issues a certificate, valid for at most five years (Article 56).

8. Draw up the EU declaration of conformity

The manufacturer drafts and signs the EU declaration of conformity (Article 19, Annex IV), taking responsibility for the device's conformity. It notably states the Basic UDI-DI, the class, the standards and common specifications applied and, where applicable, the notified body certificate.

9. Affix the CE marking

The CE marking is affixed visibly, legibly and indelibly to the device or its sterile packaging, to the instructions for use and to the sales packaging (Article 20, Annex V). Where a notified body was involved, its identification number appears next to it.

10. Register the device and prepare for life on the market

• Register the device in the EUDAMED UDI and device module.
• Prepare labelling and instructions in the languages required by each Member State of sale.
• Start post-market surveillance, PMCF and the vigilance system.

After marking: continuous conformity

CE marking commits the manufacturer to what follows: post-market surveillance, PSURs, vigilance, notified body surveillance audits, change control. Any significant change to the device must be assessed and, where required, submitted to the notified body before implementation.

Common mistakes

1. Classifying too late: the class drives budget, timeline and choice of notified body.
2. Choosing a notified body whose scope does not cover the device.
3. Underestimating clinical evaluation, especially for class III and implantable devices.
4. Forgetting EUDAMED: without an SRN, no notified body application.
5. Treating marking as an end point: it opens an obligation of continuous surveillance.

Between the first step and the certificate, harmonised standards, MDCG guidance and transition rules may change: medical device regulatory monitoring means you do not discover them during an audit.