While there is no requirement for a manufacturer of products requiring the CE mark to appoint an Authorised Representative based within the EU (see our page on this topic for further details), the new Machinery Directive does contain a requirement for non-EU based manufacturers to appoint someone within the EU to act as their representative for the delivery of technical documentation in the event of an enforcement action.
The actual mechanism by which this requirement is established is contained in Annex II of Directive 2006/42/EC, which deals with the content of Declarations. Item 2 of the list for both Declarations of Conformity and Declarations of Incorporation states as follows:
name and address of the person authorised to compile the technical file, who must be established in the Community
The purpose of this requirement is to deal with an issue which the enforcement authorities for the Directive have found to be an increasing problem, namely that they have difficulty in obtaining the technical documentation which allows them to assess whether or not a product has been correctly CE marked.
Its important to understand that this requirement is not about requiring a manufacturer who is based outside the EU to appoint an Authorised Representative. The function of a formally appointed Authorised Representative, and their relationship with the manufacturer, is quite different. This requirement is about ensuring that the enforcement authorities have timely access to the information they need to assess whether the machine has been correctly CE marked.
Its also worth noting that the Directives do not require the technical documentation to be actually stored in the EU. This is dealt with in Annex VII to the Machinery Directive, which states;
The technical file does not have to be located in the territory of the Community, nor does it have to be permanently available in material form. However, it must be capable of being assembled and made available within a period of time commensurate with its complexity by the person designated in the EC declaration of conformity.
To help non-EU manufacturers meet these requirements, Conformance has set up its DoC-EUPoint service.
Doc-EUPoint is a service offered by Conformance Ltd. to help manufacturers based outside the EU to meet their obligations under the Machinery Directive 2006/42/EC.
We will permit non-EU based clients to use our contact details on their Declarations of Conformity in return for a small charge and a commitment to provide the information required in the event of a formal request from an enforcement authority.
Key features of our service include:
- Comprehensive service from a long established specialist
Conformance has been offering CE marking consultancy services for over 15 years. We have completed over 2500 CE marking related projects and have wider experience than any other specialist consultancy worldwide.
- Confidential, independent service
Our contract includes a commitment never to release your technical documentation to anyone without your express permission. You can use us as a way to get the information required by the enforcement authorities without any risk that it will fall into the hands of your competitors or customers. We are not an authorised representative or a Notified Body. Our service is focused entirely on your interests.
- High reliability, highly secure file storage service
Our systems incorporate automatic off-site backups and comply with international standards for data security.
- Low cost, modular service
Our service is structured to be easy to understand and so that you only pay for what you need. See the costs tab for module prices.
- One stop shop for additional CE marking services
If you need guidance on what your technical documentation should contain, a list of the standards which apply to your product, an annual update on the standards and directives, or an assessment of your technical documentation, Conformance can provide all these and more.
Manufacturers of machinery are required to identify on their Declarations of Conformity (and Declarations of Incorporation) an address from which the technical file for their machine can be obtained by the European enforcement agencies. This address must be within the EEA, so manufacturers based outside Europe must find someone within Europe to act on their behalf.
Manufacturers who already have an Authorised Representative will have little difficulty in fulfilling this requirement, but other manufacturers who do not have a suitable relationship with a company in Europe will find it cheaper and more convenient to use DOC-EUPOINT.
Even if you have an authorised representative already, you are not obliged to use them as a means of delivering technical documentation to the European enforcement agencies. You may wish to retain the flexibility to move your representation from one company to another without having to change your Declarations, or you may simply want to avoid having to send your technical documentation to your EU based agent (for instance, they may sell both yours and your competitors products). In either case, DOC-EUPOINT provides a cost effective, reliable and independent service to fulfil your legal obligations.
Our commitment to you:
We will allow you to use our company name and address on your declarations of conformity.
We will provide an initial response to all enquiries from EU based enforcement agencies on your behalf within three working days of receipt of an enquiry.
We will keep your information confidential and secure. We will not show it to anyone outside of Conformance Ltd without your express permission.
We will ensure that our charges for any Doceupoint services will be clear, transparent and agreed with you in advance
We will provide a detailed account of the time spent and actions undertaken for any chargeable follow-up service required to respond to enforcement enquiries.
Your commitment to us:
You will pay the fees agreed in the contract promptly
You will only use our contact details in the way which we have agreed
You will supply us with copies of any Declarations which are issued by you bearing our name
You will promptly inform us about any new products or changes to the product where you will be using our contact details
You will promptly supply us with the technical documentation which we request when asked for it.