Whether in the EU or worldwide, it is easy to spot a CE marking on many products. CE stands for the French “Conformité Européenne”, which means “European Conformity”. The symbol is mandatory for products sold in the European Union and European Economic Area only when there are EU specifications requiring the affixing of the marking on those products. It is forbidden to affix the CE marking on products for which it is not required. Some of the products that require a CE marking are:
- Medical devices and in vitro diagnostic medical devices
- Construction products
- Machinery equipment
- Electronics, including radio and telecommunication equipment
- Personal protective equipment
- Pressure equipment
- Toys
- Equipment and protective systems for use in explosive atmospheres
Meaning and responsibilities
When a product bears the CE marking, it means that the manufacturer has assessed the product and considered it to meet the applicable safety and health requirements. Manufacturers can assess a product themselves, or involve a third-party conformity assessment body, the notified body. In certain cases, the involvement of a notified body is mandatory, such as with high-risk medical devices and high-risk personal protective equipment.
Most importantly, the manufacturer responsible for the conformity assessment is the legal manufacturer, meaning the company placing the product on the market under their name. Consequently, the legal manufacturer is responsible for, among other things:
- Preparing the technical documentation and Declaration of Conformity
- Ensuring that the documentation is available to competent authorities upon request
- Keeping the documentation for 10 years from the date the product is placed on the market
- Affixing the CE marking
The authorised representative can perform some of these activities and guide the manufacturer towards the EU and EEA market access. Under certain regulations, non-EU manufacturers are obliged to appoint an authorised representative if they want to sell in these markets.
How to affix the CE marking
Manufacturers must affix the CE marking in a visible, legible, and indelible manner. Several websites of the European Commission provide different formats of the marking. Some instructions to affix the marking include:
- Both letters (CE) should have the same vertical dimension and be no smaller than 5mm (unless specified differently by the law).
- If it is not possible to display the marking on the product itself, manufacturers can affix it on the packaging or to any accompanying documents, such as the Instructions for Use (IFUs).
- The marking can be in whichever colour as long as it is visible.
The marking does not expire but the documentation related to that product must be kept up to date.
CE marking in the United Kingdom
In August 2023, the United Kingdom announced indefinite CE mark recognition for a wide range of products sold in Great Britain. Among these products, this decision applies to toys, machinery, pressure equipment, electronics, equipment for potentially explosive atmospheres (ATEX), and personal protective equipment (PPE).
The authorised representative can play a pivotal role in verifying compliance with the applicable EU and UK requirements and ensuring smooth market access. Do you have any questions on how to sell products in Europe? Write your questions here!
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