b) If the required arrangement between the two parties is such that the name and address of the OEM cannot appear on the product label, then the trade agent has to take full responsibility for compliance with Directive 94/9/EC including as appropriate, conformity assessment and product/production quality assurance (see below), CE marking, preparing the declaration of conformity etc.
Conformity Assessment procedures
A trade agent may apply for a second EC Type Examination certificate which will be issued in the name of the trade agent.
The trade agent will need to show that it is responsible and in control of production by providing the following information:
An application form signed by the trade agent.
A copy of the original EC Type Examination certificate.
A declaration by the OEM that the product to be placed on the market in the name of the trade agent will be identical to that described in the original EC Type Examination certificate.
A declaration by the trade agent that the product to be placed on the market in his own name will be identical to that described in the original EC Type Examination certificate.
The product marking label drawing of the trade agent.
A copy of the product instructions that comply with Directive 94/9/EC Annex II, Clause 1.0.6.
A copy of the contractual agreement between the OEM and the trade agent.
The second EC type-examination certificate, issued to the trade agent, will include a reference to the original EC type-examination certificate.
Product/Production Quality Assurance
Manufacturers have to comply with the production control requirements in Article 8 of Directive 94/9/EC.
In addition to holding an EC Type Examination certificate in his own name, the trade agent is also responsible for engaging a notified body to approve and carry out surveillance of their quality management system for controlling the situation.
It is this notified body whose number will appear after the CE marking on the trade agent label.
An application by a prospective ATEX trade agent for a Quality Assurance Notification will require an audit at the trade agent’s premises. This audit will be somewhat limited in its scope but will include a review of the contract between the OEM and trade agent, and will address such requirements as customer-related processes, preservation of product and control of nonconforming product.
More Information?
For further information please call or contact Alan Barber or Christine Goodfellow :
e:mail alan.barber@baseefa.com or christine.goodfellow@baseefa.com
