CE Marking
European Conformity Marking
Scope
EU/EEA Internal Market
Legal Basis
Reg. (EC) 765/2008
Relevant for
Medical devices, PPE, Toys
The CE marking is the most important conformity marking for products in the European internal market. It indicates that a product meets all applicable EU harmonization legislation and can be freely traded within the EU.
For disposable products such as medical gloves, protective clothing, and respiratory masks, the CE marking is mandatory. The manufacturer thereby declares conformity with all applicable directives (e.g. MDR for medical devices, PPE Regulation for protective equipment).
Frequently Asked Questions
Is the CE marking a quality mark?
No, the CE marking is not a quality mark but a manufacturer's declaration of conformity. It states that the product meets applicable EU directives.
Which products require CE marking?
All products falling under an EU harmonization directive, e.g. medical devices, PPE, electrical equipment and toys.