CE Marking and Authorised Representatives

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.

Where a manufacturer has a subsidiary or a formally authorised distributor based somewhere within the EU it is usually fairly clear who has to take responsibility for CE marking. Things get more complex when the manufacturer sells direct to EU customers without going through an agent based on EU soil. Experience indicates that the complex realities of actual relationships between manufacturers, importers, distributors and customers make any attempt at generalising on this issue completely 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.

One thing which is clear, however, is that manufacturers are by and large free to make their own mind up how they handle this. The only directive which requires appointment of a representative within the EU is the Medical Devices Directive. In all other cases the definition of who is responsible for CE marking if the manufacturer is not based within the EU is left (deliberately?) unclear.

Conformance has been providing CE marking consultancy longer than most. We have looked at providing 'authorised representative' services for non EU based manufacturers and have concluded that, even in the case of medical devices, it cannot be done. Being able to fulfil the role of authorised representative is not simply a question of being a (paid) sitting duck for the authorities. It is clear to us that this job can only be done by someone who has a long lasting and deeply detailed involvement with the manufacture of the product concerned. CE marking is not simply about making a product meet the requirements of a few standards at the time it is designed - it is about having a complete overview of the manufacture and use of a product over its whole life.

In reaching the conclusion that the 'authorised representative' as a service has no value to us or the client, we looked at it from three points of view. We reached the same conclusion all ways.

In the first instance we took the view that we could act as nominal agent and sign the Declaration. However, by doing so we would clearly have to take responsibility for any modifications that the manufacturer decided to make to the product, whether or not we were informed of them and whether or not we approved of them. To have sufficient control over the design and manufacture of the product that we could be happy to take the risks involved in this for all time would involve totally unrealistic demands on the client's resources, both financial and otherwise. However, without this control one is reduced to simply taking a fee and gambling that it's worth the risk. This is the way the insurance companies make their money but it cannot be considered good business for reputable consultancies!

From the manufacturer's point of view the story is much the same. Obviously the primary reason they should not be paying for this service is because in most cases they are not obliged to have it, but even where they are I would contend that to try to buy representation as a service in its own right is foolish. Again, one must consider the long term. If we assume that the product in question is legitimately CE marked at the time it is first placed on the market, the things which will require the attention of the authorised representative are (1) product returns due to manufacturing and other defects, (2) modifications to products which take them outside of the requirements of the directives and (3) changes to the standards or directives which make the original product no longer compliant. Most product safety consultancies would be very happy to deal with (2) and (3), but these services cannot be provided without a close and ongoing relationship between the companies in question and (1) in particular requires a direct involvement in the sales of the product. In the consultant/client relationship the flow of money is in completely the wrong direction for the relationship to have the necessary long term value to the manufacturer.

Finally there is the point of view of the enforcement authorities. Notwithstanding the legal status of the importer, agent, distributor or any other member of the supply chain, what the authorities want is a 'warm body' they can grab in order to see some action in response to a product complaint. If all they want is a copy of some documentation then the filing cabinet keeper is fine, if he is sure that the contents of his cabinet are up to date and accurately represent the units which are being shipped. Years into the life of any product, that's a big 'if'. Moreover, the enforcement authorities can do much more than just demand paperwork and although one can undoubtedly write a contract which provides for remedies between the representative and the manufacturer in the event of the representative having to pay for a product recall, enforcing such a contract will be well nigh impossible if the manufacturer chooses not to play ball. The time scales on which the authorities have these powers are likely to exceed those of most business relationships, often by an order of magnitude. While the predatory lawyers of an individual looking for a quick buck in a liability case may be very happy to take on anyone who is in any way associated with the faulty product, the authorities want to see depth in the relationship between representative and manufacturer so that they know that there are the necessary resources available to respond to problems if they arise.

The person responsible for signing the Declaration of Conformity has to have enough clout with the manufacturer to know what any actions taken by the design, production, sales or purchasing departments of the manufacturer will mean to the status of the product under the CE mark directives, not just now, but for the whole of a product's production life (and arguably for ten years after that). It is difficult enough for a wholly owned subsidiary to keep track of these things. To expect an external contractor such as a consultancy to be able to do it flies completely in the face of the realities of the situation.

It is our belief that manufacturers should very wary of getting involved in 'authorised representative service' arrangements - they are legally unproven and in our opinion are unnecessary. In the long term they are unlikely to provide you with what you think you are paying for.