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ITC
Medical Devices - summarizing the current situation in area of preparation / transfer of notified bodies to the new legislation

The European Associtiation for Medical devices of Notified Bodies (TEAM NB) on web site, in the section "Latest News", published on December 14, 2018 a document called "White Paper: One Year of Application" summarizing the current situation in area of preparation / transfer of notified bodies to the new legislation regarding to Medical Devices Regulation (MDR) and In-Vitro Medical Devices Regulation (IVDR).


International Trade Fair MEDICA 2019

Dear business partners, let us invite you to visit our exposition at the International Trade Fair for medical sector Medica 2019, which will be held 18. – 21. 11. 2019 in Düsseldorf. Our stand will be located in Hall 15, Stand E42 (Czech exhibitors stand Ministry of Industry and Trade). For detailed information please contact Ms Barbora Hajkova, e-mail: bhajkova@itczlin.cz. Contact details of ITC HERE


Determination of resistance to cutting by sharp objects

Laboratory of textile has successfully accredited testing procedure EN ISO 13997 - Determination of resistance to cutting by sharp objects. The test is performed mainly on protective gloves and similar PPE.

For further information and testing, please, contact our laboratory: textile@itczlin.cz, phone: +420 577 601 268.


New telephone numbers were launched

Dear clients. New telephone numbers of workers who moved from workplace Zlín-Louky to workplace Zlín, Svit area, Building nr.113 were launched. In case of problems, please contact the headquarters at +420 572 77 99 22. Thank you for your understanding.


Sale of the part of CSI plant – effective date 1st July 2019

Institut pro testování a certifikaci, a.s., and Centrum stavebního inženýrství a.s. concluded a contract on sale of part of plant, which came into effect 1st July 2019


In-vitro diagnostic medical devices

Products certification, CE » Conformity assessment (CE)

In-vitro diagnostic medical devices (IVDs) are used for measuring the amounts of specific substances in the blood (or urine or other body fluids), for the measurement of the physical properties of the sample, for the microscopic evaluation of cells, for growing microbiological cultures and for similar purposes. The IVD must meet the relevant requirements of Council Directive 98/79/EC. The IVD must undergo the appropriate method of compliance assessment, on the basis of which the EC declaration of conformity is issued and for which each product carries the CE marking. Institute for testing and certification is a member of TEAM-NB and is a  signature of an ethics code (Code of Conduct).

 

Preliminary questionaire   Manual for clients
Application for conformity assessment   Searching the database of certificates
GFA (general framework agreement)   News
Legislation and  other documents for conformity assessment      

SERVICES PROVIDED IN CONNECTION WITH CONFORMITY ASSESSMENT OF MEDICAL DEVICES

  • Conformity assessment by the Notified Body No. 1023 according to the requirements of the:
    • Council Directive 98/79/EC, laying down the technical requirements for in vitro diagnostic medical devices
    • Council Directive 2006/95/EC, laying down the technical requirements for low voltage electrical equipment
    • Council Directive 2004/108/EC, laying down the technical requirements for products in terms of their electromagnetic compatibility
  • 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

PRODUCTS ASSESSED IN ITC ACCORDING TO the Council Directive 98/79/EC

Institute for Testing and Certification, Inc. is notified as the Notified Body No. 1023 for conformity assessment of all in vitro diagnostic medical devices.

CONTACTS

Person Phone e-mail
Tomas Zavisek, Ing.,
Head of department medical devices certification
+420 572 779 955 tzavisekPostaitczlin.cz


Post address:
Institute for testing and certification, a.s.
Department of medical devices certification
trida Tomase Bati 299, Louky, 763 02 Zlin
Czech Republic

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

Updated: 4.10.2019
 
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