All CE mark directives place responsibility for compliance on the manufacturer of the product concerned. Even where the manufacturer is outside the European Union, and therefore out of legal reach of the EU enforcement authorities, the manufacturer has certain obligations (e.g. quality control) which they cannot pass to other parties. However, where the manufacturer is not based in the EU, legal responsibility for compliance with the directives lies with the person responsible for selling the goods within the EU.
Authorised Representatives
The need for, and obligations of, authorised representatives are much misunderstood. In particular, there is a common misconception that a manufacturer who is not based within the EU must appoint an Authorised Representative before they can legitimately put the CE mark on their products and that the technical documentation must always reside within the EU. Neither of these are correct.
Manufacturer’s Responsibilities
All CE mark directives place responsibility for compliance on the manufacturer of the product concerned in the first instance. Even where the manufacturer is outside the European Union, and therefore out of legal reach of the EU enforcement authorities, there are certain obligations under the Directives which only the manufacturer can fulfil. Examples are finished goods quality control and the correct selection of components.
Appointment of an Authorised Representative
If the manufacturer is not based in the EU then the Directives say that their ‘Authorised Representative’ (if they have one) must take responsibility for CE marking. The definition of an Authorised Representative (AR) is someone who has a formal contract with the manufacturer to represent them within the EU. It does not simply mean anyone who happens to purchase and import an item of equipment from outside the EU.
Except in the case of the Medical Devices Directive, the appointment of an AR is optional on the part of the manufacturer. If a manufacturer appoints an AR then the AR must fulfil the role defined in the Directives, but nowhere in any of the directives is there an explicit requirement to for a manufacturer to appoint a representative based in the EU before they can legitimately CE mark their product.
For medical devices, the situation is rather more complex. 'Manufacturers' of class one devices and medical procedure packs are required to register with the Competent Authority in which they are based, and Competent Authorities will only accept registrations from within their own territory. Additionally, it is a requirement of the Directive that manufacturers who are not resident within the EEA must designate someone within the Community to be responsible for the product and that their address must appear on the product. De facto, that person becomes the manufacturer's Authorised Representative.
With the introduction of the new Machinery Directive 2006/42/EC this matter has been made a even more complex because 2006/42/EC requires the name and address from which the machine’s technical documentation can be obtained to be specified on the Declaration of Conformity. This requirement is not itself new (it also appears in the Noise Emissions Directive, 2000/14/EC) but what is new is that the address specified must be within the European Community.
From one perspective at least, this actually helps to clarify the requirements for non-EU based manufacturers since it’s clear that if the Commission had meant the directives to force manufacturers to appoint an EU representative then they would have said so, but instead they have gone for a less prescriptive approach.
Importer Responsibilities
If the manufacturer is based outside the EU and does not appoint an official Authorised Representative, then the person importing the products becomes responsible for ensuring that they comply with the directive(s) which apply to them. At very least, it is recommended that the importer obtain a copy of the original Declaration of Conformity.
Experience indicates that the complex realities of actual relationships between manufacturers, importers, distributors and customers make any attempt at generalising on this issue fruitless. Each case must be looked at carefully to determine who is best placed to deal with the issues surrounding the CE marking of the product. The only certainty is that the CE marking procedures must be applied, so someone has to take responsibility for them.
Authorised Representative Services
Some companies offer ‘authorised representative services’ as part of a range of services designed to ‘help’ their clients obtain the CE mark. Generally, the service will consist of making a charge for the storage of a manufacturer’s technical documentation. Such services may have some value if they provide a regular update to the requirements and standards for the manufacturer’s products, or some provide a contact point for EU based customers. However, manufacturers should be careful that they know what they are buying before then enter into such agreements – they are not a requirement of CE marking and they may not provide the benefits which you think you are paying for.
Conformance does not provide an Authorised Representative service, but we can help our clients fulfil the requirements of the Machinery Directive by providing an EU contact point whose name and address can go on your Declarations. See our DocEUpoint service for more details.
