Contrary to some reports, the new Machinery Directive 2006/42/EC will not prevent manufacturers based outside Europe from self-certifying their products when it comes into force on 29 December 2009, according to Nick Williams, Managing Director of Conformance Ltd, a consultancy that specialises in CE marking and product safety.
The requirements for appointing an Authorised Representative (AR) within Europe will remain the same as under the old Directive 98/37/EC and, as now, appointment of an AR will be optional. If manufacturers choose not to appoint an AR, they may continue to do all of the work associated with the assessment of machinery and the compilation of the necessary technical documentation themselves. Even for annex IV machines there is no change to the option for self-certification where the manufacturer follows completely the guidance of an applicable type C standard - in fact the new Directive makes CE marking simpler in these cases, since there will no longer be an obligation to deposit the Technical File with a Notified Body.
What will change is that the new Directive introduces a requirement for Declarations to give the name and address of the person from whom the authorities can obtain a copy of the technical file for a machine, and this address must be based within the European 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 that enables them to assess whether or not a product has been correctly CE marked.
Conformance Ltd is therefore launching a new service to help machinery manufacturers based outside Europe to fulfil this obligation. Called DoC-EUpoint (pronounced doc-U-point), this service provides a cost-effective, modular approach to providing a European address to go on the manufacturer's Declarations. A small charge is made to cover the cost of establishing a contract with the manufacturer, and a small annual fee is levied for the period that the arrangement stays in place. Additional charges are only made if an enforcement action takes place and copies of the documentation are requested. Furthermore, regular reviews of the applicable standards and directives, and an initial review of the documentation to confirm that it contains everything which is required, can be added to the basic DoC-Eupoint service at a discounted rate.
For more details, visit the DoC-EUpoint web page at www.doceupoint.eu or www.conformance.co.uk/doceupoint.