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.

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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:

  • Evaluation of conformity – for medical devices in classification class I
  • Evaluation of conformity by a notified body – for all the other classification classes
  • Conducting tests of electrical safetyelectromagnetic compatibilityRoHS
    • active implantable medical devices – annexes 3, 4
    • active medical devices – annexes 3, 4
  • Issuing test reports
  • Issuing the EZÚ certificate
  • Evaluation of technical documentation
  • Certification of quality systems in accordance with the annexes of the Government Directive and ČSN EN ISO 13485:2012 standard
    • Active implantable medical devices – annexes 2, 5
    • Active medical devices – annexes 2, 5, 6
    • Non-active medical devices – annexes 2, 5, 6
    • Non-active implantable medical devices – annexes 2, 5, 6

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. 55/2015 Coll. – Council Directive 90/385/EEC, 2007/47/EC for active implantable 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.