EU Declaration of Conformity
The EU Declaration of Conformity (EU DoC) is a legally binding document issued by the manufacturer - or their EU Authorised Representative - for a product before it is placed on the market with CE marking.
Mandatory content of an EU Declaration of Conformity:
- Name and address of the manufacturer (and authorised representative where applicable)
- Product description and unique product identification (e.g. model, REF)
- All applicable EU regulations or directives
- Notified Body (name and identification number) if involved
- Reference to the harmonised standards applied
- Date and legally binding signature
For medical devices, the EU DoC is governed by MDR (EU) 2017/745 Article 19 and Annex IV. For PPE, by PPE Regulation (EU) 2016/425 Article 15.
The EU DoC must be made available to market surveillance authorities on request. Importers and distributors have the right to request it from the manufacturer. It must not be confused with a certificate issued by a Notified Body.
Frequently asked questions
What must be included in an EU Declaration of Conformity?
Mandatory content: manufacturer/EU authorised representative, product description including REF, applicable EU legislation, Notified Body involved with identification number, harmonised standards applied, date and signature.
Who may issue an EU Declaration of Conformity?
Only the manufacturer or - for manufacturers outside the EU - their officially designated EU Authorised Representative. Importers and distributors may not issue their own declaration for third-party products.
Is the EU Declaration of Conformity the same as a Notified Body certificate?
No. The EU DoC is the manufacturer's own declaration. A Notified Body certificate (e.g. EU type-examination certificate) is an additional third-party document required for CE marking from Class IIa / PPE Category II upwards.