The process of obtaining the CE marking involves not only the physical application of the mark on the product, but a whole procedure of inspection, testing, preparation and retention of documentation.
Who needs CE marking?
CE marking is mandatory for manufacturers, importers and authorized representatives supplying goods to the EU market that are regulated by the so-called “new approaches” to technical regulation. These include, in particular:
- electrical equipment;
- machinery and equipment;
- medical devices;
- gas equipment;
- construction materials;
- household appliances;
- personal protective equipment;
- radio and telecommunication equipment.
If the products belong to categories covered by European directives, it is illegal to sell them without CE marking.
Basic documents for obtaining CE marking
- Technical File (Technical File)
This is the key set of documents that proves that the product complies with all the requirements of the directives. It must be available on request from the competent EU authorities for 10 years after the product has been put into circulation. The technical documentation usually includes:
- a general description of the product;
- drawings, diagrams, specifications;
- lists of standards applied;
- results of calculations, tests, reports;
- risk analysis;
- descriptions of used materials, components, design solutions;
- operating instructions;
- information on certification by third-party bodies (if necessary).
This file must be written in the official language of the EU and comply with the requirements of the specific directive (or several directives, if the product falls under several at the same time).
- Declaration of Conformity (EU Declaration of Conformity)
This is an official document by which the manufacturer or its representative declares that the product complies with all applicable requirements. The declaration specifies:
- the name of the product;
- the manufacturer’s details;
- the EU directives and harmonized standards that have been applied;
- details of the notified body (if one has been involved);
- date and signature of the authorized person.
This document must accompany the product and be kept by the manufacturer for 10 years.
- Test results / certificates (if required)
In some cases, depending on the product category, independent laboratory reports may be required to confirm safety:
- independent laboratory reports;
- сertificates of conformity;
- results of inspections or audits;
- risk assessments in accordance with EN ISO 12100 or other standards.
If provided for by law, the company must engage a notified body to carry out the official conformity assessment and issue a certificate. For example, this applies to high-end medical devices, explosive equipment, elevators, etc.
Additional documents
Depending on the type of product, you may need:
- internal production control protocols;
- quality management system (e.g. ISO 9001);
- explanations of labeling, packaging, user instructions;
- documents on the origin of raw materials or components;
- contracts with an authorized representative in the EU.
Who is responsible for preparing the documentation?
It is the responsibility of the manufacturer to ensure that the paperwork is correct. If the products are imported from outside the EU, this responsibility is partially or fully borne by the importer or authorized representative within the European Union.
Documents must be more than just prepared – they must comply with directives, be structured, be stored in an accessible form, and be ready for inspection by regulatory authorities at any time.
What are the consequences for not having proper documentation?
- fines (up to €100,000 in some EU countries);
- withdrawal of products from the market;
- prohibition of sale;
- criminal liability for consumer deception.
Obtaining CE marking is not a one-time formality, but a legally important process that begins with properly prepared documents. Without a complete set of technical documentation, a declaration of conformity and, if necessary, the opinions of notified bodies, the manufacturer has no right to sell its products in the EU.
To avoid mistakes, delays and financial losses, it is worth contacting the professional consultants of Standards & Quality, who will help to prepare the documentation in accordance with all the requirements of the specific directive.
