What is a Declaration of Conformity?
The DoC is the final administrative step in the conformity assessment process. By drafting and signing it, the manufacturer explicitly takes full legal responsibility for the product's compliance with all relevant safety, health, and environmental protection laws.
This document must be made available to market surveillance authorities immediately upon request, and for some high-risk products or specific directives, a copy must physically accompany the product.
Identifying Applicable Directives and Regulations
The core of the DoC is a declaration of which laws the product complies with. You must list all relevant legislation. For an electronic device, this might include the Low Voltage Directive (LVD), the Electromagnetic Compatibility (EMC) Directive, and the RoHS Directive.
If you are applying both CE and UKCA marks, the document must cite both the EU Directives and the corresponding UK Statutory Instruments.
Listing Harmonized and Designated Standards
While directives outline the essential requirements, standards provide the technical specifications used to prove compliance. The DoC must reference the specific standards applied during testing.
For the EU, these are Official Journal 'Harmonised Standards' (typically prefixed with EN). For the UK, they are 'Designated Standards' (typically prefixed with BS). You must include the standard number and the version year.
- Reference EU Harmonised Standards for CE.
- Reference UK Designated Standards for UKCA.
- Include the publication year of the standard.
Mandatory Document Elements and Signatory
A valid DoC requires specific identifying information: a unique document number, a clear description of the product (including model or serial numbers), and the manufacturer's name and full business address.
Finally, the DoC must be signed and dated. The signatory cannot be a low-level employee; it must be an individual with the authority to legally bind the manufacturing company, such as a CEO, Managing Director, or Head of Quality Assurance.
Frequently asked questions
Do I need a separate DoC for CE and UKCA marks?
While you can sometimes combine them if the underlying standards align perfectly, it is best practice to issue separate DoCs citing the specific EU directives and UK statutory instruments.
Who is authorized to sign the Declaration of Conformity?
The DoC must be signed by an individual with the authority to bind the manufacturer legally, such as a CEO, Director, or Quality Manager.
How long should I keep the Declaration of Conformity on file?
The DoC and its supporting technical documentation must generally be kept for 10 years after the last unit of the product has been placed on the market.
Does a DoC mean my product was independently tested?
Not necessarily. For many directives, a DoC represents self-certification by the manufacturer, unless a Notified Body's involvement is specifically mandated by the legislation.