Regulation

CE marking for medical devices

The letters "CE" on a medical device sold in the EU are a regulatory declaration: the manufacturer states that the device meets the General Safety and Performance Requirements of EU device law and has gone through the conformity-assessment route appropriate to its risk class.

What the CE mark means

The CE mark — from Conformité Européenne — is the symbol affixed by the manufacturer to a product that falls within the scope of one of the EU "new approach" directives and regulations. For medical devices, the relevant instrument is Regulation (EU) 2017/745 (MDR), supplemented by Regulation (EU) 2017/746 (IVDR) for in-vitro diagnostic devices. The CE mark on a device certifies that the manufacturer has carried out the conformity-assessment procedure prescribed for the device's classification and that the device meets the General Safety and Performance Requirements set out in Annex I of the MDR.

For classes IIa, IIb and III, and for certain sub-categories of Class I (sterile, measuring, reusable surgical instruments), the CE mark is accompanied by the four-digit identification number of the notified body that carried out the relevant part of the conformity assessment. For ordinary Class I devices self-certified by the manufacturer, the CE mark appears without a notified-body number.

Device classes

• Class I — low-risk devices. Most non-sterile, non-measuring Class I devices may be self-certified by the manufacturer, who draws up the technical documentation, issues a declaration of conformity, and affixes the CE mark.
• Class I sterile / measuring / reusable surgical — Class I with one of these special attributes requires notified-body involvement limited to the sterility, metrology or reprocessing aspect.
• Class IIa — medium-risk devices, requiring notified-body conformity assessment.
• Class IIb — higher medium-risk devices, with more demanding conformity assessment.
• Class III — high-risk devices, including most implants and life-supporting devices, with the most demanding conformity assessment route.

The classification rules are in Annex VIII of the MDR. They reflect such factors as the duration of contact with the body, whether the device is invasive, whether it is active (powered), and the part of the body it interacts with. Devices commonly found in parapharmacies — plasters, wound dressings, digital thermometers, saline sprays, certain orthopaedic supports, compression hosiery up to Class II — sit in the lower risk classes.

The declaration of conformity

The manufacturer's EU declaration of conformity (Article 19 of the MDR) is the formal document by which the manufacturer states that the device complies with the Regulation. It must contain the manufacturer's name and address, the device identifier (UDI-DI), the risk class, the conformity-assessment procedure applied, and references to the standards or common specifications used. The declaration of conformity must be made available to authorities and, on request, to economic operators in the supply chain.

UDI

The Unique Device Identifier (UDI) is composed of a UDI-DI (device identifier, specific to a model and packaging level) and a UDI-PI (production identifier, specific to a batch, expiry date or serial number). The UDI must appear on the device label and, where appropriate, on the device itself, and must be registered in EUDAMED. The UDI is intended to support traceability for vigilance, recall and market-surveillance purposes.

What CE marking does not mean

The CE mark is not an EU-wide quality endorsement and it is not a certificate of clinical superiority. A CE-marked device has demonstrated, through the appropriate conformity-assessment route, that it meets the General Safety and Performance Requirements for its intended purpose. It has not been benchmarked against any specific competitor product. Comparative effectiveness is not a CE-marking criterion.

The CE mark is also not a marketing-authorisation analogue to that used for medicinal products. Medicinal products are authorised, before marketing, by a competent medicines authority (the European Medicines Agency at central level, or a national medicines agency) on the basis of a full dossier on quality, safety and efficacy. Medical devices, including Class III devices, do not go through a comparable pre-market authorisation by a regulator: the manufacturer is responsible for conformity, with notified-body involvement scaled to risk.

For consumers and retailers

For a consumer or a parapharmacy retailer looking at a medical device, the CE mark with (where required) the notified-body number is a baseline indication of legality on the EU market. A device without a CE mark, or with a CE mark that lacks the notified-body number where one would be required by its class, is non-compliant. A four-digit number after the CE mark can be cross-checked against the EU Commission's NANDO database of notified bodies. The instructions for use (IFU) supplied with the device should be in the language(s) required by the Member State in which the device is made available; for many parapharmacy devices in lower risk classes, certain information may be supplied in electronic form under Implementing Regulation (EU) 2021/2226.

Last reviewed: May 2026.