- Stage:
Describe the technical characteristics of the product;
Determining which directives the product is covered by;
Search for product-specific standards;
Determination of applicable directives and harmonized standards;
Examination of Quality Management System requirements;
(Some directives require a quality system in the CE marking process.)
- Stage:
Technical Documentation / Preparation of Technical File;
Risk Analysis;
Preparation of operating instructions according to the norms;
Product testing, analysis and technical controls;
(These controls can be carried out by means of within the company or by Notified Bodies or test laboratories when necessary.)
Publication of the Declaration of Conformity;
When necessary, obtaining a certificate and / or test report from the Notified Body or testing organization
- Stage:
CE Markto the product in accordance with the relevant directive
- Stage:
The Technical Dossier of the product should be kept for the period specified in the directive and archived in such a way that it can be submitted to the competent authorities / market surveillance authorities when necessary.
