We have done quite a bit of digging around in this area. Our understanding of the position is as follows:
Declarations of Conformity and Technical files (where applicable) must be kept (stored) on EEA soil. In this respect, the manufacturer has two options. 1) The manufacturer can delegate certain responsibilities under the directive to an authorised representative. In this context, the authorised representative can be mandated by the manufacturer to sign Declarations of Conformity and enter into other committments with respect to product compliance. The degree to which the representative acts in this manner, however, is dependent on the agreement with the manufacturer. It is normal for the representative to hold Declarations of Conformity but it is not specifically neccessary for the representative to sign the Declarations, although many do with agreement/mandate from the manufacturer. 2) If the manufacturer has no representative in the EEA, the Declarations of Conformity and technical file produced by the manufacturer must be held by the prime importer of the equipment. There is some confusion in my view how this works if there is no prime importer for Europe but rather importers for each country. However, this is fairly easy to resolve by the manufacturer nominating one of the importers as an authorised representative. For both of these options, the manufacturer can sign the declarations of conformity, in fact under option 2, the obligation is on the manufacturer to sign. Hope this helps Nick -------------------------------------------------------------------- - Nick Evans Tel: +44 (0)1600 772220 GENESYS TELECOM Fax: +44 (0)1600 716744 Singleton Court Mobile: +44 (0)385 367348 Wonastow Road EMAIL: [email protected] Monmouth Gwent NP5 3AH UK -------------------------------------------------------------------- -- World-wide Market Access and Regulatory Compliance Consultants -------------------------------------------------------------------- --
