Declaration of Conformity
Declaration of Conformity (in the EU context: EU Declaration of Conformity) is the legally binding document the manufacturer - or their EU Authorised Representative - issues before a product is placed on the market with CE marking.
Mandatory content per MDR (EU) 2017/745 and PPE Regulation (EU) 2016/425:
- Name and address of manufacturer (and EU Authorised Representative where applicable)
- Unique product identification (model, REF)
- All applicable EU regulations or directives
- Notified Body (name and identification number) if involved
- Reference to harmonised standards applied
- Date and legally binding signature of manufacturer
Distinctions:
- Declaration of Conformity = manufacturer's own declaration
- EU type-examination certificate = Notified Body certificate (complementary, not a substitute)
- The EU DoC alone is not sufficient from Class IIa - a Notified Body must be involved
Retention obligation: the EU DoC must be retained for at least the product's lifetime and made available to national authorities on request.
Frequently asked questions
What is the difference between a Declaration of Conformity and an EU type-examination certificate?
The EU Declaration of Conformity is the manufacturer's own declaration. The EU type-examination certificate is a certificate from the Notified Body after EU type-examination. From Class IIa (MDR) and PPE Cat. II, both are required - the manufacturer's declaration and the Notified Body certificate.
Can an importer issue their own Declaration of Conformity?
No. The Declaration of Conformity may only be issued by the manufacturer or - for non-EU manufacturers - the EU Authorised Representative. Importers and distributors do not issue their own EU DoC.
How long must the EU Declaration of Conformity be retained?
Under MDR, for at least the product's expected lifetime, but a minimum of 10 years after the last date of placing on the market. For implantable devices, a minimum retention period of 15 years applies.