The CE marking is governed by the general principles set out in Article 30 of Regulation (EC) N:o 765/2008 (Regulation setting out the requirements for accreditation and market surveillance relating to the marketing of products).
The CE marking shows that a product
- meets all the essential requirements set for it;
- is in compliance with all the requirements laid down in the applicable directives;
- has been evaluated in accordance with these requirements.
CE marking measures mean that the manufacturer of the product or its authorised representative declares that the product meets the minimum standards concerning safety, health, environmental protection and consumer protection. By means of market surveillance, the authorities also monitor and seek to prevent the abuse of the CE marking. The CE marking may only be affixed to products to which it can be affixed under the relevant Community harmonisation legislation. The CE marking may not be affixed to any other product.
The CE marking shall be affixed before the device is placed on the market. If a product does not bear the CE marking required by law or the marking is non-compliant, the product may be ordered to be withdrawn from the market.
Article 20 of the Regulation of the European Parliament and of the Council on medical devices (MD Regulation) EU/2017/745 and Article 18 of the Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices (IVD Regulation) EU/2017/746 set out the following concerning CE marking of conformity.
Devices, other than custom-made or investigational devices, considered to be in conformity with the requirements of the Regulation shall bear the CE marking of conformity, as presented in Annex V.
The CE marking shall be affixed visibly, legibly and indelibly to the device or its sterile packaging. Where such affixing is not possible or not warranted on account of the nature of the device, the CE marking shall be affixed to the packaging. The CE marking shall also appear in any instructions for use and on any sales packaging.
The CE marking shall be affixed before the device is placed on the market. It may be followed by a pictogram or any other mark indicating a special risk or use.
Where applicable, the CE marking shall be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in Article 52 of the MD Regulation (Article 48 of the IVD Regulation). The identification number shall also be indicated in any promotional material which mentions that a device fulfils the requirements for CE marking.
Where devices are subject to other Union legislation which also provides for the affixing of the CE marking, the CE marking shall indicate that the devices also fulfil the requirements of that other legislation.
The CE marking shall consist of the initials ‘CE’ taking the following form:
If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing shall be respected. The various components of the CE marking shall have substantially the same vertical dimension, which may not be less than 5 mm. This minimum dimension may be waived for small-scale devices.
CE-marking of Medical Devices (MD and IVD directive) - Fimea 5/2022 (Not available in English)