Directive 94/9/EC: Certificates and CE marking without the name of the original manufacturer
Certificates and CE marking without the name of the original manufacturer
Case 1: Authorised Representative
The manufacturer applies for assessment and the certificate, if granted, is in the name of the manufacturer.
The EC declaration of conformity and the application of the CE marking may be effected either by the manufacturer or his authorised representative, but not by both. Required marking shall show the manufacturer's name and the number of the notified body involved in the manufacturer's production phase shall appear be placed after the CE marking.
Any person who is not an authorised representative is not allowed to issue an EC declaration of conformity or to apply the CE marking.
An authorised representative is assimilated with and regarded as an extension of the manufacturer's operation. The name of the manufacturer shall be on the rating plate.
Case 2: De facto Manufacturer
Any person who is not the manufacturer may apply for assessment and, if successful, have the certificate granted in his name and puts his name on the rating plate provided he can satisfy the chosen notified body that he is fully responsible and has control over the design of the saleable product.
Irrespective of where the product is manufactured, he can issue the EC declaration of conformity, affix the CE marking and add the number of the notified body concerned with the approval of the production phase provided he is fully responsible for and in control of the production.
In this case, he is the "de facto" manufacturer of the product. He can show full responsibility by, for example, placing a sub-contract for production with the actual manufacturer. The "de facto" manufacturer, in this case, is also responsible for engaging a notified body to approve and carry out periodic surveillance of the quality management system used in production, whether in the EU or elsewhere in the world.
The number to be applied after the CE marking is that of the notified body appointed by the "de facto" manufacturer to assess the quality management system.
Case 3: Second EC-type certificate in a second manufacturer's name
A manufacturer A, whose quality management system is approved according to directive 94/9/EC by a Notified Body x, produces and sells equipment for which he holds an EC-Type examination certificate issued in his own name. A manufacturer B, whose quality management system is approved according to directive 94/9/EC by another notified body y, applies for an EC-Type certificate in his name, B, based on the certificate previously granted to manufacturer A. On receipt of the certificate he then manufactures the product, issues his own declaration of conformity, affixes the CE-mark with the identification number of the notified body y and sells the equipment in his own name.
Alternatively, manufacturer B may choose to have the equipment manufactured under sub-contract. In this case he must ensure that the quality system used by the sub contractor is in compliance with the relevant requirements of directive 94/9/EC. If the quality system is again approved by notified body y the manufacturer B can issue his own declaration of conformity, affix the CE-mark together with the identification number of the notified body y and sell the product in his own name.
Note : Although the procedure for issuing a second EC-type certificate in a second manufacturer's name is not explicitly covered by 94/9/EC, it would appear justifiable in order to support established commercial practices, e.g. manufacturing or selling under licence.
In applying for the second certificate, manufacturer B will be expected to submit to the appropriate notified body:
- the original certificate,
- a declaration by the original manufacturer that the equipment to be produced under the name of the second manufacturer will be identical with the originally certified equipment,
- a declaration by the second manufacturer that the equipment brought to the market will be identical to that originally certified, and
- a copy of the contractual agreement between A and B.
The line of quality management could then be followed back to the original CE-type assessment.