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. Currently (September 2020) 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
Except in the case of the medical devices directives (Medical Devices Directive, In-vitro Diagnostic Devices Directive, Active Implantable 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 and in their contract with the manufacturer, but nowhere in any of the directives is there an explicit requirement 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.
Most manufacturers will probably want to appoint an AR rather than rely on their importer or a FSP, for several reasons:
- they may not want their importer to see all their technical documentation in the event of a MSA action;
- their importer(s) may be reluctant to be put in a position where they have to deal with an MSA action;
- a manufacturer may have several importers and each will need to be responsible for the compliance of the products sold through them if there is no single AR appointed.
Importer and Distributor Responsibilities
The purpose of an Authorised Representative is to provide a point of contact to make it easy for the market surveillance authorities within the EU to communicate with the manufacturer. Additionally, the AR may also draw up and sign the manufacturer's Declaration of Conformity, they may hold the technical documentation and they may also have other responsibilities which must be defined in a 'written mandate' agreed between them and the manufacturer.
However, the AR may not have any responsibility at all for the importation of goods into the EU. The importer function is quite separate from the AR function, and does not necessarily involve a written contract between the manufacturer and the importer. An importer is defined as anyone who places product from outside the EU market on sale within the EU market. The importer must:
- ensure that the CE marked product is properly compliant with the CE marking requirements before placing on the market;
- identify themselves as the importer and provide their name and address on the product packaging or Instructions for use (IFU);
- ensure IFU in the language of the end user are provided;
- store and transport the products in such a way as to ensure they remain fit for purpose;
- keep records of any complaints, problems etc. and act on them appropriately;
- if necessary, recall products which are faulty;
- keep copies of the documentation and Declaration of Conformity for at least 10 years after the last date on which the product was sold;
- respond to requests for information and co-operation from market surveillance authorities (MSA).
A 'distributor' is anyone within the EU, other than the manufacturer or importer, who is in the supply chain. A distributor must:
- verify that the product bears the CE marking;
- ensure the product is accompanied by the required documents and IFU in a language which can be easily understood by consumers and other end-users;
- ensure the goods are identified with model, serial and/or batch identification numbers;
- ensure that the name and address of the manufacturer (or, if that address is not within the EU, the name and address of either their Authorised Representative, Importer or FSP) is on the goods;
- take the necessary steps to ensure that goods conform to the applicable requirements;
- inform the manufacturer or the importer, and the MSA, if goods are unsafe;
- store and transport the products in such a way as to ensure they remain fit for purpose;
- take any necessary corrective action required to ensure products comply with the applicable CE marking requirements;
- if necessary, to withdraw and/or recall non complying product;
- keep copies of the documentation required to demonstrate these obligations have been met;
- respond to requests for information and co-operation from MSA;
Authorised Representative Services
Until publication of the Goods Package there was very little point in manufacturers based outside the EU formally appointing an Authorised Representative, unless they were selling medical devices. However, from July 2021, all manufacturers based outside the EU must appoint an AR (or an importer or a FSP) within the EU if they wish to continue to sell CE marked goods within the EU.
Conformance does not provide an Authorised Representative service, but our sister company "Authorised Representative Service' based in Dublin in the Irish Republic does. Please contact Authorised Representative Service directly, or contact Conformance for details.
Implications of Brexit
The UK ceases to be a member of the EU on 31 December 2020. After that date, companies based within the UK are no longer located within the EU for the purposes of CE marking and will therefore need to appoint an AR within the EU. Similarly, companies wishing to sell goods within the UK will need to appoint a UK Representative who will have the same obligations and responsibilities as an EU AR. Authorised Representative Service can also provide a UK Representative service for manufacturers based outside the UK
