Understanding CE Marking Directives: Three common confusions with CE Marking
Understanding the CE Marking Directives can be a challenging process. One of the most common areas of confusion, which Element's CE Marking experts are most frequently asked about, is when CE Marking actually applies. To understand this, it is important to understand if a product is being “made available on the market”, being “placed on the market” or being “put into service or use”.
Making available on the market
Whether in return for payment or free of charge, a product is “made available” on the market when supplied for distribution or use on the European Union market in the course of commercial activity. This supply includes any offer for distribution or use on the market which could result in actual supply (e.g. an invitation to purchase, advertising campaigns).
Supplying a product is only considered as making it available on the market when the product is intended for end users on the market. The supply of products whether for further distribution, for incorporation into a final product, or for further processing or refinement with the aim to export the final product outside the Union market is not considered as making available.
The central role that the concept of making available plays in CE Marking is related to the fact that all economic operators in the supply chain have traceability obligations and need to have an active role in ensuring that only compliant products circulating on the market.
The concept of making available refers to each individual product, not to a type of product, and whether it was manufactured as an individual unit or in series.
Placing on the market
A product is “placed on the market” when it is made available for the first time on the Union market.
Products made available on the market must comply with the applicable CE Marking directive at the moment of placing on the market.
The operation is reserved either for a manufacturer or an importer i.e. the manufacturer and the importer are the only economic operators who place products on the market.
When a manufacturer or an importer supplies a product to a distributor or an end-user for the first time, the operation is always labeled in legal terms as placing on the market. Any subsequent operation, for instance, from a distributor to distributor or from a distributor to an end-user is defined as making available.
As for “making available”, the concept of placing on the market refers to each individual product, not to a type of product, and whether it was manufactured as an individual unit or in series. Consequently, even though a product model or type has been supplied before a new CE Marking directive, individual units of the same model or type must comply with these new requirements.
Both making a product available and placing a product on the market require an offer or an agreement (written or verbal) between two or more legal or natural persons for the transfer of ownership, possession, or any other property right concerning the product in question after the stage of manufacture has taken place. This transfer could be for payment or free of charge. It does not require the physical handover of the product.
Placing on the market is considered not to take place where a product is:
- Manufactured for one's own use. Some directives however cover products manufactured for their own use in its scope (e.g. LVD, Machinery)
- Bought by a consumer in a third country while physically present in that country and brought by the consumer into the EU for the personal use of that person
- Transferred from the manufacturer in a third country to an authorized representative in the Union whom the manufacturer has engaged to ensure that the product complies with the harmonization legislation
- Introduced from a third country in the EU customs territory in transit, placed in free zones, warehouses, temporary storage, or other special customs procedures (temporary admission or inward processing)
- Manufactured in a Member State with a view to exporting it to a third country (this includes components supplied to a manufacturer for incorporation into a final product to be exported into a third country)
- Transferred for testing or validating pre-production units considered still in the stage of manufacture
- Displayed or operated under controlled conditions at trade fairs, exhibitions, or demonstrations
- In the stocks of the manufacturer (or authorized representative) or the importer, where the product is not yet made available, that is, when it is not being supplied for distribution or use, unless otherwise provided for in the applicable harmonization legislation
Products offered for sale by online operators based in the EU are considered to have been placed on the market, regardless of who placed them on the market. Products offered for sale online by sellers based outside the EU are considered to be placed on the market if sales are specifically targeted at EU end-users. Products offered for sale by online operators need to comply with all applicable EU rules when placed on the market.
The placing on the market is the most decisive point in time concerning the application of harmonized legislation. When made available on the market, products must be in compliance with the harmonization legislation applicable at the time of placing on the market. Accordingly, new products manufactured in the Union and all products imported from third countries - whether new or used - must meet the provisions of the applicable harmonization legislation when placed on the market i.e. when made available for the first time on the market.
Compliant products may subsequently be made available along the delivery chain without additional considerations, even in case of revisions to the applicable legislation or the relevant harmonized standards, unless otherwise specified in the legislation.
Member States have an obligation in the framework of market surveillance to ensure that only safe and compliant products are on the market. It must be noted that used products made available to consumers in the course of commercial activity are subject to the General Product Safety Directive (GPSD).
Putting into service or use (and installation)
“Putting into service” takes place at the moment of first use within the Union by the end user for the purposes for which it was intended. The concept is used, for example, in the field of Lifts, Machinery, Radio equipment, Measuring instruments, Medical devices, In-vitro diagnostic medical devices or products covered by the EMC or ATEX directives, in addition to placing on the market, and results in the scope of harmonization legislation being extended beyond the moment of making available of a product.
Member States may not prohibit, restrict or impede the putting into service of products that meet the provisions of the applicable harmonization legislation. However, Member States are allowed to maintain and adapt, in compliance with the Treaty (in particular Articles 34 and 36 TFEU) and subject to CE Marking, additional national provisions regarding the putting into service, installation, or use, of products which are intended for the protection of workers or other users, or other products. Such national provisions may not require modifications of a product manufactured in accordance with the provisions of the applicable harmonization legislation.
The need to demonstrate compliance with products at the moment of putting into service, and - if applicable - that they are correctly installed, maintained, and used for the intended purpose, should be limited to: products which have not been placed on the market prior to their putting into service or which can be used only after an assembly, an installation or other manipulation has been carried out; or products whose compliance can be influenced by the distribution conditions (for example storage or transport).
As a Notified Body for the key EU product safety and communications directives, Element is able to provide expert help and guidance to support products through the relevant testing process. For advice on CE Marking a device, please contact Element or call UK +44 808 234 1667 or US +1 888 786 7555.