Medical devices

EZÚ offers services for:

  • Active implantable medical devices
  • Active medical devices
  • Non-active medical devices
  • Non-active implantable medical devices

Announcement of changes by the manufacturer to the certificate HERE.

Ing. Kateřina Sedláčková

Ing. Kateřina Sedláčková

Direct support for these services

Premium product

For increasing the product attractiveness, competitiveness on the market and sales support

EZÚ offers the following services for the correct introduction of products to the market:

The Government Directive no. 54/2015 Coll. – Council Directive 93/42/EEC, 2007/47/EC for medical devices .

The Government Directive no. 481/2012 Coll.on the restriction of the use of certain hazardous substances in electric and electronic equipment.
Certification of quality systems in accordance with the ČSN EN ISO 13485:2012 standard.