CE marking of medical devices

The letters CE stand for Conformité Européenne, meaning: in conformity with European legislation. A CE marking on a medical device indicates that the product complies with the requirements of the applicable European legislation — in this case, Regulation (EU) 2017/745 on medical devices (MDR). This marking is mandatory for products placed on the market within the European Economic Area (EEA: the EU plus Norway, Iceland, and Liechtenstein).

The CE marking is not a quality mark, but a declaration by the manufacturer that the device meets all relevant requirements of the MDR. By affixing the CE marking, the manufacturer confirms that the appropriate conformity assessment procedure has been carried out and that a valid EU Declaration of Conformity is available. This makes the manufacturer legally responsible for the safety and performance of the product.

The MDR provides different routes for conformity assessment depending on the risk class of the device. For low-risk devices (e.g. Class I), self-certification by the manufacturer is permitted. For higher-risk devices (Classes Is, Im, Ir, IIa, IIb, or III), assessment by a Notified Body is required. In such cases, the CE marking must be accompanied by the four-digit identification number of the involved Notified Body.

The CE marking must be visible, legible, and indelible on the device itself, or – if not possible – on the packaging and accompanying documentation.