Review of Compliance Documents
You must not assume that all manufacturer documents will stand up to a government review. In addition, reports or declarations of conformity created by inspection bodies cannot always be updated "just in time" on request.
Therefore, make sure that you have all the necessary documents to avoid sanctions and inconveniences before the market surveillance authorities ask you to inspect them.
Subsequent requests for documents that have not been checked always pose a high risk.
Suddenly there is no longer a supplier, which is not uncommon for suppliers from third countries outside the EU.
But the supervisory authorities are not interested in that, You are the EU importer or, if applicable, also the “quasi-manufacturer” I support you in compilation of the complete conformity documents before you market the product!
Declarations of conformity, as well as all reports, evidence and documents that are used to presume conformity, must be available at all times and should not be requested from the supplier of the product until the authorities request them for review
As experience has shown, the manufacturer usually provides the (EU) importers with the requested documents, but these are very often incomplete or incorrect.The listed standards for presumption of conformity are often not listed in the Official Journal of the European Union and are therefore not accepted by the supervisory authorities.
This means that the importer has affixed the CE marking to his product, but there are no indications of a "presumption of conformity" or standards have been used which have not been published (more) than harmonized standards.Policies are often "forgotten" or policies are listed that do not apply to the product.
If only one of these points is disregarded, the market surveillance authority assesses the declaration of conformity as inadmissible and orders appropriate measures or conditions that are usually to be fulfilled at short notice.In such cases, it is often very difficult to obtain updated documents from the manufacturer within the specified time in order to meet the agreed deadlines.
We would be pleased to support you in this area.
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