INSTITUTE FOR TESTING AND CERTIFICATION

Medical devices

ITC does not currently carry out conformity assessments of medical devices in accordance with Council Directive 93/42 / EEC on medical devices due to their expiry. Currently, only audits (assessment of the manufacturer's quality system) of medical devices are performed in accordance with the requirements of Article 120 (3) of the MDR.  ITC is in the process of assessing of Application for Notification under the new Regulation (EU) 2017/425 of the European Parliament and of the Council on medical environments, amending Directive 2001/83/EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.

Links / Downloads

SERVICES PROVIDED IN CONNECTION WITH CONFORMITY ASSESSMENT OF MEDICAL DEVICES

  • Testing in the Accredited Laboratory No. 1004 and No. 1004.3
  • Granting licenses for voluntary certification mark “ITC certified quality
    ITC grants a license for the use of the quality mark, which is granted to the products where high standard of safety and quality parameters has been proved by certification and where meeting the prerequisites of the producer for continuous quality compliance has been proved through inspection visits.
  • Standardization services - analyses of technical information
  • Certification of management systems (ISO 13485, ISO 9001, ISO 14001, OHSAS 18001)
  • Technical inspection - statistical inspections, inspection certificates

CONTACTS

Tomas Zavisek, Ing.

head of department medical devices certification


Post address:
Institute for testing and certification, a.s.
Department of medical devices certification
trida Tomase Bati 5264, 760 01 Zlín, Czech Republic
 

Remeteiova Lydia

deputy of head of department medical devices certification

Luptakova Zuzana, Ing.

deputy of head of department medical devices certification


Post address:
Institut pro testování a certifikaci, a. s.
Department of medical devices certification
Mlynské Nivy 54
821 05 Bratislava
Slovak Republic

The person responsible for accuracy of data: Ing. Tomas Zavisek