The applicable laws define a “manufacturer” as a business based within the EU that manufactures or gets a third party to design or manufacture a product and markets the product with a view to placing it on the EU market under their own name or trademark.
Product’s compliance with requirements
It is the manufacturer’s responsibility to ensure that products placed on the market are safe and compliant. A product is deemed to satisfy the essential requirements (“presumption of conformity”) if
- the manufacturer has designed, manufactured, examined and tested the product in accordance with the harmonised standards, and
- the product complies fully with the applicable harmonised standards.
Products that satisfy the essential requirements are allowed to move freely within the EU market.
However, the application of harmonised standards is voluntary. Manufacturers can also choose some other way to demonstrate conformity with the essential requirements. However, it is more difficult in practice to demonstrate conformity with the essential requirements by another means than through harmonised standards.
EU laws determine whether a third party (“Notified Body”) is required for the conformity assessment. Notified Bodies are approved by a national authority to carry out conformity assessment, notified to the European Commission and listed in the NANDO database. Market surveillance authorities do not inspect products before they are placed on the market.
In the case of serial production, manufacturers must have procedures in place for ensuring that all their products satisfy the essential requirements.
Manufacturers are responsible for
- drawing up technical documentation as required by EU laws
- demonstrating that their product satisfies all the essential requirements in accordance with a proper conformity assessment procedure
- preparation and signature of the EU declaration of conformity
- affixing the CE marking to each product placed on the market.
Labelling, information and instructions
Prior to placing a product on the market, manufacturers must
- ensure that the equipment bears all markings, instructions and information required in EU legislation, to ensure the safe and purposeful deployment, use, maintenance, and decommissioning of the product
- ensure that all products have a type, batch or serial number that allows them to be identified
- label the product with their name, registered trade name or trademark and address.
If it is not possible to state the aforementioned details on the product itself, the information can be provided in the product’s packaging or in a leaflet supplied with the product.
Several product standards include provisions on information and markings that must be shown on the products. Standards also set out detailed requirements concerning information, instructions and warnings that must be included in instruction leaflets.
Manufacturer’s obligations after a product has been placed on the market
Manufacturers must factor in any changes in the product design, properties, harmonised standards or technical specifications on which the declaration of conformity is based and assess their effects on conformity. If necessary, a new conformity assessment must be carried out.
Manufacturers must keep all EU Declarations of Conformity, technical documentation and details of businesses to which products have been supplied for a period of 10 years from when the product was placed on the market. Market surveillance authorities can ask manufacturers to present the aforementioned product information and documents at any time. Manufacturers have a duty to cooperate with the competent authorities.
Manufacturers must investigate any complaints made about their products, any non-compliances identified and all cases where products have been returned and keep records if necessary. Manufacturers must notify the retailers of their products of any remedial action that retailers must also take on the basis of complaints, non-compliances or product returns.
Some directives and regulations stipulate that importers must carry out sample testing on products that are already on the market to safeguard the health and safety of consumers and other end users, as well as the environment. This requirement applies to cases where testing is deemed necessary to address risks posed by the products. For example, this can be the case with certain simple pressure vessels that require certification, as well as ATEX equipment, and if the manufacturer has received an unusually large number of complaints, or if inspections by market surveillance authorities have revealed an unusually large number of non-compliant products.
Manufacturers can appoint a representative for themselves by giving them written authorisation. The representative must be established within the EU. Representatives can be authorised to perform certain administrative duties, such as affixing CE marking and drawing up EU Declarations of Conformity.
An authorised representative must have a mandate for at least the following tasks:
- keeping EU Declarations of Conformity and technical documentation available for market surveillance authorities for a period of 10 years from when the product is placed on the market
- providing the competent authority with any information and documents required for demonstrating the conformity of the product
- cooperating with the competent authority to ensure the conformity of the product.
Manufacturers cannot delegate their responsibility for ensuring that their products are designed and manufactured in compliance with the applicable requirements or their responsibility for drawing up technical documentation to an authorised representative.
Authorised representatives must keep the details of any businesses to which products have been supplied for a period of 10 years from when the last product was placed on the market.
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