The manufacturer is the key person when it comes to CE marking and it is only the manufacturer who has the right to affix the CE mark. Once a product is manufactured and the CE mark is attached, all other businesses in the supply chain and ultimately the consumer, should be able to trust that the product is safe and complies with all applicable EU rules.
Manufacturers’ responsibilities
When it comes to CE marking, the manufacturer is the key person in the process as they are the only person who can apply the CE mark to a product in the legal, technical and practical meaning.
The CE mark is the final step of a process and the steps that a manufacturer needs to take are as follows:
1) Identify the applicable legislation
2) Identify the applicable requirements of the legislation
The manufacturer needs to identify the relevant legal requirements in order to understand whether a product is subject to CE marking or not. Only some product types require the CE mark, and it is illegal for a manufacturer to affix the CE mark to a product that it is not required on. The European Commission’s website contains detailed summaries of EU legislation.
3) Conformity assessment
There are various ways for a manufacturer to assess conformity:
a) The manufacturer can assess the safety and compliance of the product with the help from an external test laboratory. At the end of the assessment, the manufacturer will declare that the product is safe and complies with all relevant EU legislation, and they will draw up the EU declaration of conformity. This process is called ‘self-assessment’.
b) For more complex products, such as medical devices, it is mandatory to work with external parties, commonly known as notified bodies. The notified body will test and verify the product and perhaps also monitor the manufacturer’s production control depending upon the type of product. This process is called third-party verification.
4) Compile the technical documentation
The technical documentation contains the documentation of all assessments undertaken for a certain product. The most important chapters in the technical documentation include risk assessment, detailed descriptions of the design and manufacture including drawings, test reports and certificates and the signed EU declaration of conformity.
5) Make an EU declaration of conformity and affix the CE mark
The EU declaration of conformity is a formal statement, and it is legally binding evidencing that all information provided is correct and that all steps in the conformity assessment have been conducted in compliance with all applicable legislation. It identifies the manufacturer, it identifies the product, it lists the applicable directives and the standards that have been applied and last, but most important, it is signed by the manufacturer. Once a manufacturer reaches the final step of the process, they can affix the CE marking to the product.
The manufacturer must store the declaration of conformity and the technical documentation for at least 10 years and must be ready to make it available to market surveillance authorities within 10 days if it is requested.
The importer’s responsibilities
The importer can act like a bridge between the distributor and the EU representative. To meet this important role, the importer should:
- Check if a product bears the CE mark properly together with other required information: product name, batch number, manufacturer’s name and address. If a product cannot be physically checked, adequate photographs should be requested.
- Ask for the EU declaration of conformity for the product. This must be in English or in the language of the product’s destination country.
- Ask the for the technical documentation for the product. This should contain all information that is necessary to prove that a product was made in conformity with all applicable EU rules.
The declaration of conformity and the technical documentation must be stored for at least 10 years so they can be presented, if any problems arise or the EU authorities ask for it.
Responsible person
EU law also requires that anyone who exports a relevant product to EU must have a representative physically present in the EU whom the EU authorities and consumers can contact, if, for example, the safety of a product is questionable. This requirement applies to product groups listed in Art. 4(5) of the Regulation on Market Surveillance and Compliance of Products. These include for instance toys and electrical products.
This EU representative could be the importer, a fulfilment house or another representative authorised by the manufacturer. In general terms this requirement specifically applies when the product is subject to systematised conformity assessment and is subject to CE marking. Even goods advertised from websites and dispatched from countries outside the Single Market are still considered to be placed on that market for regulatory purposes if EU consumers are able to buy them and have them delivered direct to them.
EU law describes four obligations for the responsible person:
- Verify that the EU declaration of conformity and the technical documentation have been drawn up. They must store both documents for at least 10 years.
- During these 10 years they must be prepared to provide the declaration of conformity and the technical documentation to an EU market surveillance authority in less than 10 days on request.
- Contact the market surveillance authorities on their own initiative, if they have reason to believe that the product is unsafe.
- Co-operate with the market surveillance authorities or even take action themselves to remove unsafe products from the market or mitigate risks posed by their products.
Besides checking the documentation, it is also considered to be good practice for this economic operator to carry out general visual checks of the products to ensure all the required labelling and the CE mark are displayed and that the product conforms to the technical specification. Screen tests could also be carried out on the product.
Distributors’ responsibilities
Distributors are any actors in the supply chain, other than the manufacturer or the importer, who make a product available on the market.
Distributors are obliged to verify that products bear the CE marking (where this is required), that they are accompanied by the required documents, instructions and safety information in the language of the country of sale and that each product is marked with the name and contact detail of the manufacturer and the importer (or the EU representative).
If a distributor has reason to believe that a product is unsafe or not in conformity with the legal requirements, they should stop selling the product and inform the manufacturer or the importer as well as the market surveillance authorities. Distributors must transport, handle and store products to ensure compliance with the safety requirements is not jeopardised.
Safety Gate/RAPEX
Safety Gate/RAPEX is a system that ensures information sharing on dangerous non-food products between EU market surveillance authorities. In order to protect consumers, a dangerous product can be banned from the market and the economic operator can be asked to recall all sold products at their own costs. In extreme cases, they can even be requested to destroy the products.
You can learn more about Safety Gate/RAPEX in the ‘Common product safety issues’ module.
