Affixing a CE Mark in your devices for EU
Updated: Jul 4
Some products require CE marking before they can be sold in Europe. The CE Marking process involves compliance with certain european directives or regulations, like the MDR, IVDR or machinery and after obtaining approval, the manufacturer must to affix the CE mark on the device or in the packaging.
The CE mark is a certification mark that indicates a product's conformity with European Union (EU) health, safety, and environmental protection standards. CE stands for Conformité Européene, which translates to European Conformity. The CE mark is required for many products before they can be legally placed on the market in the European Economic Area (EEA), which consists of the EU member states, as well as Iceland, Liechtenstein, and Norway. It signifies that the product meets the essential requirements outlined in relevant EU directives or regulations.
By affixing the CE mark, the manufacturer or authorized representative declares that the product complies with all applicable EU directives or regulations and has undergone the necessary conformity assessment procedures. These procedures may involve testing, documentation review, quality assurance, or a combination of these elements, depending on the product category. The CE mark is not a quality mark or an endorsement of performance but rather indicates compliance with specific EU requirements. It provides a uniform standard across the EEA, allowing products to circulate freely within this market.
It is important to note that the CE mark applies only to products within its scope and is not applicable to services, although certain products with embedded software or electronic components may fall under its requirements.
This CE mark is a clear indication that the product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements, as per the EU requirements . By affixing the CE marking to a product, a manufacturer declares that the product meets all the legal requirements for CE marking and can be sold throughout the EEA. This also applies to products made in other countries that are sold in the EEA.
As EU Authorized Representative we must ensure that the CE marking in your medical devices or machinery products is:
In our experience the best is downloading the CE marking from the EU link:https://single-market-economy.ec.europa.eu/single-market/ce-marking_en
Please, note that not all products must have CE marking. It is compulsory only for most of the products covered by the New Approach Directives. It is forbidden to affix CE marking to other products.
Please note that a CE marking does not indicate that a product have been approved as safe by the EU or by another authority. It does not indicate the origin of a product either.
Any questions, contact your Eu Authorized Representative and they will be able to help you!