§77 元の製造業者の名称のない証明書及びCEマーキング

Different possible cases are dealt with in this section.

Case 1: Authorised representative

The manufacturer applies for assessment and the certificate, if granted, is in the name of the manufacturer.

The EU declaration of conformity and the application of the CE marking may be done 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 EU 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 EU 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 EU-type examination certificate in a second manufacturer or trade agent’s name

A manufacturer A, whose quality management system is approved according to Directive 2014/34/EU by a notified body NB1, produces and sells equipment for which he holds an EU-type examination certificate issued in his own name. A second manufacturer acting as a trade agent B, whose quality management system is approved according to Directive 2014/34/EU by another notified body NB2, applies for an EU-type examination certificate in his name, B, based on the certificate previously granted to original manufacturer A by a notified body NB. After reception of the certificate, he manufactures the product, issues his own EU declaration of conformity, affixes the CE-mark with the identification number of the notified body NB2 and sells the equipment in his own name on the EU market.

Alternatively, manufacturer B may choose to have the equipment manufactured under subcontract. In this case he must ensure that the quality system used by the sub-contractor is in compliance with the relevant requirements of Directive 2014/34/EU. If the quality system is again approved by notified body NB2, the manufacturer B can issue his own EU declaration of conformity, affix the CE-mark together with the identification number of the notified body NB2 and sell the product in his own name on the EU market.

Although the procedure for issuing a second EU-type examination certificate in a second manufacturer’s name is not explicitly covered by Directive 2014/34/EU, it would appear justifiable in order to support established commercial practices, e.g. manufacturing or selling under licence.

In applying for the second certificate, in order to get the required product certification for the EU market place, manufacturer or trade agent B has to submit to the appropriate notified body: - the original or a copy of the EU-type examination certificate issue by notified body NB in A’s name, - a declaration by the original manufacturer A that the equipment to be produced under the name of the second manufacturer or trade agent B will be identical with the originally certified equipment, - a declaration by the second manufacturer or trade agent B that the equipment brought to the EU market will be identical to that originally certified, and - the original or a copy of the contractual agreement between A and B.

NB, as the notified body assessing manufacturer A’s product, will issue a new EU- type examination certificate and report based upon the EU-type examination certificate and report issued in manufacturer A’s name.

This is necessary to follow the line of quality management back to the original EU- type examination assessment, to ensure the traceability of Quality Assurance. In fact, manufacturer or trade agent B needs to get the required Quality Assurance Notification (QAN) for the EU market place: notified body NB2 assessing B’s quality assurance system will issue a Quality Assurance Notification to B once they have assured that the requirements of the appropriate Directive Annex has been satisfied. Since B does not physically produce the ATEX product himself, a full assessment against Annex IV or VII cannot be achieved unless the compliance of manufacturer A’s quality assurance system, as the actual producer of B’s product, has been established to ensure the following: - the line of quality assurance can be followed back to the original EU-type examination assessment issued by notified body NB1 and held by manufacturer A; - compliance with the requirements of Annex IV or VII have been demonstrated through the combined quality assurance systems of trade agent B (covered by the

QAN issued by notified body NB2) and the actual producer, manufacturer A (covered by the QAN issued by notified body NB1); - an appropriate quality assurance system exists for the products identified in EU- type examination certificate, so that notified body NB2 can issue its own QAN to trade agent B and permit the use of its NB2 number adjacent to the CE-mark on the label of the B's product.

See the diagram in the next page:

So, trade agent B has been granted an EU-type examination certificate, issued by notified body NB, based upon the EU-type examination certificate issued in manufacturer A’s name, and holds a Quality Assurance Notification in his own name, issued by notified body NB2, that allows that the ATEX product placed onto the market in B’s name to bear NB2 number. NB2 must inform NB1 accordingly.

The EU market is presented with a new ATEX product that appears to be made by B and satisfies the requirements of the ATEX Directive; but the market place, in principle, has no knowledge of the relationship between companies B and A, and, under the ATEX Directive, B is considered the "manufacturer" and has fulfilled all the necessary requirements for a manufacturer.

In order to ensure that the requirements of the directive are effectively fulfilled, it is necessary to keep visible traceability of the QAN held by trade agent B to the QAN issued to manufacturer A, in particular to guarantee: - that the original EU-type examination certificate held by A and used as the basis for the EU-type examination certificate issued to B is included in an existing QAN; - that the version labelled for B will be examined by the original product manufacturer's notified body NB1, during the course of their surveillance assessment as they may be unaware of the existence of B’s activities which have been conducted through a different notified body NB2.

Otherwise, there is a significant danger that the product described on the EU-type examination certificate issued to trade agent B by notified body NB is never subjected to a quality assurance system assessment at the actual place of production by NB1 as the notified body of the original manufacturer, A, fundamentally undermining the principles of the ATEX Directive.

As a solution, when trade agent B is provided with an EU-type examination certificate, B’s QAN and A’s QAN as the actual manufacturer with whom B has a contractual agreement, are to be updated to identify the products covered by B's EU- type examination certificate within the schedules. This ensure that the quality assurance system at trade agent B’s location and manufacturer A’s, the actual product producer, are examined by their relevant notified bodies NB1 and NB2.

In addition, in the event of trade agent B identifying, or being advised of, an issue related to the safety of its ATEX product, there is a mean by which the quality assurance of the product can be easily traced back to the original producer, manufacturer A, irrespective of how many notified bodies are involved, and all other trade agents of the same type of product can then be easily advised of the issues.