The CE Certificate is an independent verification of the evaluation of product conformity with the requirements of respective government directives performed by the manufacturer. By issuing a CE Certificate, the Electrotechnical Testing Institute declares that the manufacturer performed the process of evaluating conformity properly and can issue an EU Declaration of Conformity.
defining technical requirements for medical devices
The Electrotechnical Testing Institute is authorized in accordance with the Act no. 22/1997 Coll. on Technical Requirements for Products for the evaluation of conformity for the following Government Directives:
- 118/2016 Coll. defining technical requirements for low-voltage electric equipment.
- 117/2016 Coll. on the technical requirements for products in terms of their electromagnetic compatibility
- 176/2008 Coll. 176/2008 Coll. defining technical requirements for machinery
- 163/2002 Coll. defining technical requirements for construction products
- <54/2015 Coll.
- 55/2015 Coll.
We can thus issue a CE Certificate for these government directives.
What does the CE Certificate offer?
- 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
- Completion of the process of preparing documentation for the issue of an EU Declaration of Conformity
- Cost savings on own equipment necessary to conduct the required tests
Introduction of a product to the market is generally defined by the Act no. 22/1997 Coll. on Technical Requirements for Products. Requirements for specified products are defined in the respective government directives. Selection of the most important Government Directives in EZÚ competence:
|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|
|54/2015 Coll.||defining technical requirements for medical devices|
|55/2015 Coll.||defining technical requirements for active implantable medical devices|