Declaration of conformity, CE
A Declaration of Conformity is a document used by the manufacturer to demonstrate it has properly evaluated the conformity of the product with the requirements of respective government directives. This document is an essential condition for introducing a product to the market.
The manufacturer issues a EU Declaration of Conformity on the basis of an evaluation of the conformity of a particular product with the requirements of a given Government Directive (GD) For products imported from regions outside the EU, the EU Declaration of Conformity is issued by the authorized representative of the manufacturer based in the EC or the importer, or the party that last introduced the product to the EU market.
Aside from issuing a Declaration of Conformity, the product must also be marked with the CE mark or CE mark with the number of the notified body that performed the evaluation of conformity – for selected government directives.
The Electrotechnical Testing Institute is authorized in accordance with the Act no. 90/2016 Coll. on Technical Requirements for Products to conduct the evaluation of conformity for the following Government Directives:
- 118/2016 Coll. defining technical requirements for low-voltage electric equipment.
- 117/2016 Coll. defining technical requirements for products in terms of their electromagnetic compatibility
- 176/2008 Coll. defining technical requirements for machinery
- 163/2002 Coll. defining technical requirements for construction products
- 336/2004 Coll. defining technical requirements for medical devices
- 154/2004 Coll. defining technical requirements for active implantable medical devices
Why use EZÚ services for evaluation of conformity?
- Guarantee of independent verification – increasing trust in relation to business partners
- Assurance in relation to market supervisory authorities – evaluation of conformity using EZÚ services will not be questioned
- Complete preparation of documentation for the issue of a Declaration of Conformity
- Cost savings on own equipment necessary to conduct the required tests
Requirements for specified products are defined in the respective government directives.
Selection of the most important Government Directives in EZÚ competence:
| 118/2016 Sb. | defining technical requirements for low-voltage electric equipment |
| 117/2016 Coll. | defining technical requirements for products in terms of their electromagnetic compatibility |
| 176/2008 Coll, | defining technical requirements for machinery |
| 163/2002 Coll. | defining technical requirements for construction products |
| 481/2012 Coll. | on the restriction of the use of certain hazardous substances in electric and electronic equipment |
| 54/2015 Coll. | defining technical requirements for medical devices |
| 55/2015 Coll. | defining technical requirements for active implantable medical devices medical devices |