Process and times
The CE certification process: stages, documents and timelines
CE marking cannot be purchased or obtained through a single inspection. It is the outcome of a structured process that the manufacturer — or their European representative — carries out in accordance with the requirements of the applicable legislation. Rxconsult, through Ing. Marco Ussei, manages this process in its entirety.
Step | Activity | Description | Indicative timeline |
1 | Preliminary analysis | Identification of applicable Directives and Regulations. Verification of relevant harmonised standards. Initial risk overview. This step is often provided free of charge or at reduced cost. | 1–2 weeks |
2 | Conformity assessment | Verification that the product meets the Essential Safety Requirements (ESR) of the applicable legislation. May be conducted internally or require a Notified Body, depending on the product’s risk category. | 2–8 weeks |
3 | Technical file preparation | Compilation of all required technical documentation: product description, technical drawings, calculations, test results, risk assessment (per EN ISO 12100 for machinery), instructions for use. | 2–6 weeks |
4 | Instructions for use | The manual must be drafted in all official languages of the countries where the product will be marketed. Italian is mandatory for the Italian market. Rxconsult provides Italian and English versions. | 1–3 weeks |
5 | EU Declaration of Conformity | Formal document by which the manufacturer or authorised representative declares the product’s conformity. Must include: manufacturer details, product description, applicable standards, reference to technical file, authorised signature. | 2–3 days |
6 | Affixing the CE marking | The CE marking is physically affixed to the product (or its packaging/nameplate), legible and indelible, with a minimum height of 5 mm. From this point, the product may be placed on the EU market. | Immediate |
Overall timeline
For a standard industrial machine, the complete process typically takes 6–16 weeks from first contact. Timelines vary depending on product complexity, availability of existing technical documentation, and whether a Notified Body needs to be involved.The advantage of working with Rxconsult
Ing. Marco Ussei has personally managed over thirty assembly line and industrial plant projects for clients including Stellantis, IVECO, Ferrari, and CNH. This hands-on experience allows him to anticipate technical issues, optimise documentation, and reduce the overall time required for the process.
Our professionals are at your disposal.