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Certification of product - Conformity assessment (CE) - In-vitro diagnostic medical devices (CE)

 

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  • SERVICES PROVIDED IN CONNECTION WITH CONFORMITY ASSESSMENT OF MEDICAL DEVICES
  • Conformity assessment by 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
    • The Applicant shall select a method of conformity assessment according to the Council Directive 98/79/EC based on categorization of in vitro diagnostic medical device
      Categories of in vitro diagnostic medical devices
      • - IVD for determining the blood groups anti-Duffy, anti-Kidd, irregular anti-erythrocytic antibodies, infections of rubella, toxoplasmosis, cytomegalovirus, chlamydia, HLA tissue groups, tumoral markers PSA, trisomy, phenylketonuria and blood sugar;
      • - IVD for selftesting.
      • - other IVD.
    • Conformity assessment procedures  
      • - Quality system assessment by the Notified Body;  (total quality assurance system)
        - Type examination by the Notified Body and verification of conformity with the certified type;
        - Type examination by the Notified Body and production quality system assessment;
        - Procedure according to the Annex No. 5 and Annex No. 7;
        - Design examination by the Notified Body for in vitro diagnostic medical device
      • Involvement of the Notified Body is not required in conformity assessment for medical devices falling under the 밢thers?category.
  • Testing in the Accredited Laboratory No. 1004 and No. 1004.3
  • Granting licences for the 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.Certifikace
  • Standardization services - search for standards, analyses of technical information, borrowing of standards
  • 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, a joint-stock company is authorized by the decision of NMZ (Czech Office for Standards, Metrology and Testing) as the Notified Body No. 1023 for conformity assessment of all in vitro diagnostic medical devices.