CE Marking
CE marking (Conformite Europeenne) is a mandatory conformity marking for certain product categories in the EEA. It is not a quality certification but declares that the manufacturer has met all applicable EU requirements.
Affixing requirements:
- Minimum height 5 mm (unless otherwise specified)
- Visible, legible, and indelible on the product or packaging
- Immediately next to CE: Notified Body identification number (for products requiring one)
- The CE mark must not be obscured by other markings
Medical devices (MDR):
- Mandatory for all medical devices placed on the EEA market
- Class I: manufacturer self-certifies after self-conformity assessment
- Class IIa, IIb, III: Notified Body required
PPE (PPE Regulation (EU) 2016/425):
- Category I: manufacturer self-certification
- Category II and III: Notified Body required
A CE mark may reference multiple EU regulations if a product falls under several frameworks (e.g. medical device AND PPE).
Misuse of CE marking is a regulatory offence and can lead to market withdrawal.
Frequently asked questions
Who is responsible for CE marking on a product?
The manufacturer bears responsibility for CE marking. For manufacturers outside the EU, the EU Authorised Representative assumes this responsibility. Importers and distributors verify conformity but do not affix their own CE marking.
Can the CE mark be applied without testing?
No. The CE mark may only be affixed after the required conformity assessment procedure has been completed and the EU Declaration of Conformity issued. Premature or unjustified affixing is not permitted.