Yes, in accordance with the requirements of the applicable Directive, as manufacturer you shall carry out the safety assessment procedures and compiling the required documentation. All documentation should be filled in the Technical File. When a product has been tested and is found to be in compliance with the essential requirements of the European Directives and applicable standards, the manufacturer must compile an official EC Declaration of Conformity and to prove certification a CE-marking label must be affixed to the product concerned. An application for a EC-type examination, performance of that examination and issue of the EC-type examination certificate shall be carried out by a Conformity assessment body (Notified body).
Was this answer helpful?
Didn’t find what you were looking for? We are happy to help!
We take data safety serious. Read more in our Terms and Conditions.