Manufacturer’s obligations
Ensure the regulatory compliance of your product
Design, manufacture, inspect and test the product and draw up technical documentation
Draw up instructions for use
Design and manufacture – Manufacturer’s obligations
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.
The European Union has harmonised key requirements for product safety, health and environmental protection. The requirements are set out in EU laws, such as directives and regulations.
Statutes often only set out the essential requirements and mechanisms for assessing conformity. Technical details are usually set out in harmonised European standards or other documentation ratified and published by the European Commission. ‘Harmonised standards’ are standards confirmed by a European standardisation body at the request of the European Commission, the reference data for which is published in the Official Journal of the European Union.
Ensuring and demonstrating the conformity of products
A product is deemed to satisfy the essential requirements (“presumption of conformity”) if
- the manufacturer has designed, manufactured, inspected and tested the product in compliance with the applicable 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.
Generally, the application of harmonised standards is voluntary. Manufacturers can also choose some other way to demonstrate conformity with the essential requirements. In practice, however, it is more difficult to demonstrate conformity with the essential requirements by some other means than through harmonised standards.
The use of harmonised standards is mandatory, for example, for products falling under the scope of the construction products regulation.
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
- drawing up and signing an EU Declaration of Conformity
- affixing CE marking to all products that are to be placed on the market.
Labelling, information and instructions
Prior to placing a product on the market, manufacturers must
- ensure that the product is labelled in accordance with EU laws and accompanied by any instructions and information needed to use, maintain and dispose of the product safely and appropriately
- 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 is 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 in order 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. This can be the case, for example, with certain simple pressure vessels that require certification as well as ATEX equipment and if the manufacturer has received an unusually high number of complaints or if inspections by market surveillance authorities have revealed an unusually high number of non-compliant products.
Addressing non-compliances
Manufacturers must ensure that only products that conform to regulations are placed on the market.
If a manufacturer suspects that a product placed on the market is non-compliant, the manufacturer must immediately take remedial action. Remedial action can include, for example,
- rectifying the non-compliance(s)
- withdrawing the product from the market
- recalling any sold products
If the properties of a product pose a risk to safety, health or the environment, the manufacturer must notify Tukes of the non-compliance(s) and any remedial action taken.
Authorised representatives
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 item of electrical equipment is placed on the market.
