You also know that the CE mark must be backed up with a declaration of conformity and with a technical documentation file to provide evidence that the essential requirements of each applicable European Directive has been satisfied.
When neither the equipment manufacturer nor the manufacturer's authorised representative are based in Europe, then responsibility for maintaining the declaration of conformity and technical file rests with the importer.
National Regulatory Authorities are required to undertake market surveillance. Your product may be selected at random or as the result of a complaint. You may be asked to provide technical evidence of compliance and may also be required to support laboratory testing. In some European countries, should your product fail the surveillance testing process, you will be required to pay testing costs in addition to any fines demanded by the enforcer. National Regulatory Authorities have powers to impose import bans, sales bans and to require product recalls. In the most severe cases, prison sentences may be applied.
With our deep understanding of regulatory approvals, we can help you to build a regulatory documentation base that will stand up to scrutiny by the regulatory authorities. We can also help you present your documentation to the National Regulatory Authority in case of a dispute.
Even when not directly responsible for CE marking, many organisations will audit suppliers in order to protect their customers and to protect their brand.
We can help you to be sure that your supplier's product satisfies regulatory requirements by carefully examining the declaration of conformity and technical file together with any laboratory test reports and Notified Body certificates that it may contain.
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