What is the CE Marking?
CE Marking: the mandatory passport for the European market
CE marking is not a quality label. It is a legal requirement: without it, many categories of products cannot be legally placed on the market or put into service within the 27 member states of the European Union, including Italy.
The letters CE stand for Conformité Européenne. By affixing this marking to a product, the manufacturer declares, under their own responsibility, that the product complies with all applicable European Directives and Regulations on safety, health, and environmental protection.
What it means in practice
For a company exporting products to Europe, CE marking has three direct implications:
- Market access: without CE marking, a product cannot be sold, rented, transferred on any basis, or put into service within the European Union.
- Legal liability: the manufacturer is civilly and criminally liable for any damage caused by a non-compliant product. In the event of an incident, the absence of CE marking significantly worsens the producer’s legal position.
- Commercial trust: the CE marking is an immediate signal of reliability for European distributors, importers, and end customers.
The European regulatory framework
CE marking is governed by a set of European Directives and Regulations, each applicable to specific product categories. Key applicable legislation includes:
- Regulation (EU) 2023/1230 on machinery, which replaces Directive 2006/42/EC from 2027.
- Directive 2014/35/EU (Low Voltage) for electrical equipment.
- Directive 2014/30/EU (Electromagnetic Compatibility).
- Regulation (EU) 2017/745 on medical devices.
- Directive 2016/425/EU on personal protective equipment.
Who is responsible for CE marking
Responsibility for CE marking lies with the manufacturer. If the manufacturer is not established within the European Union, responsibility transfers to an authorised representative established in the EU, or to the importer who places the product on the European market. For a Chinese company selling in Italy or Europe, this means that CE compliance must be addressed before the goods are shipped.
How Rxconsult can help
Through Ing. Marco Ussei, Rxconsult provides a complete CE marking support service: from preliminary product assessment to technical file preparation, from risk analysis to the EU Declaration of Conformity. A clear, documented process, fully compliant with current European regulations.
Our professionals are at your disposal.