What should be on the EC Declaration of Conformity?
The EC Declaration of Conformity basically contains the following elements:
- Name and full address of the manufacturer and, sometimes, his representative
- Product identification (name, function, model, type, serial number and the commercial name and all relevant additional information)
- The applied Directives and sometimes the harmonised standards or other applied technical standards and specifications
- Sometimes the name and address of the person authorised to compile the Technical File, this person should be located within the Community
- Sometimes the name, address and identification number of the Notified Body
- The name and signature of the person accepting responsibility of drafting the declaration on behalf of the manufacturer or authorised representative
- The date of issue.
* a CE declaration of Conformity or DOC is officially known as EC Declaration of Conformity.
- CE Marking
- Certification Experts
- Authorized Representative
- CE Declaration of Conformity
- Competent Body (Notified Body)
- Technical File
- Information on the Product
- USA compliance
- Self certification
- Export to China
- Summary Directives
- Medical Devices