CE marking of medical devices

CE marking is the sign by which the manufacturer of a medical device attests that its product meets the general safety and performance requirements of Regulation (EU) 2017/745 or, for in vitro diagnostic devices, of Regulation (EU) 2017/746. It is a precondition for placing the device on the market and for its free movement within the Union. The manufacturer affixes it under its own responsibility, at the end of a conformity assessment procedure and after drawing up an EU declaration of conformity.

Conformity assessment procedures

The procedure depends on the class of the device. For most class I devices, the manufacturer carries out the assessment itself and draws up its declaration of conformity. For class I devices that are sterile, have a measuring function or are reusable surgical instruments, and for classes IIa, IIb and III, a notified body is involved, auditing the quality management system and, depending on the case, examining the technical documentation. The body’s identification number then accompanies the marking. Certain high-risk devices also require consultation of an expert panel on the clinical evaluation.

Obligations attached to the marking

The marking carries ongoing obligations. The manufacturer must assign each device a unique device identifier, register its products in the Eudamed European database as its modules become operational, designate a person responsible for regulatory compliance, organise post-market surveillance and report serious incidents. A manufacturer established outside the Union appoints an authorised representative, and both the importer and the distributor check that the marking and the required documentation are present.

Misuse and litigation

CE marking is neither a trade mark nor a quality label. Affixing unjustified marking, or a sign likely to mislead as to its meaning, is penalised, and market surveillance authorities may order the withdrawal of products. Infringing devices often bear a false CE marking, and the right holder may then combine an infringement action with a report to the ANSM. In patent litigation, the technical documentation and the declaration of conformity usefully describe the allegedly infringing device, and their seizure is frequently sought in the course of a saisie-contrefaçon.

Key points

CE marking is affixed by the manufacturer under its own responsibility, after a conformity assessment involving a notified body for most classes. It opens access to the Union market but commits the manufacturer to ongoing traceability and surveillance obligations. Before any distribution partnership, the validity of the notified body’s certificate, the registration of the product and the designation of the person responsible for regulatory compliance should be checked.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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