In-Vitro Diagnostic Medical Devices – CE Marking

We at QVC in cooperation with it’s alliance partner Institute for Testing and Certification (ITC) a.s. Zlin, NOTIFIED BODY NO. 1023 provide Services in connection with conformity assessment of In-vitro diagnostic medical devices,

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).

Services provided in connection with conformity assessment of medical devices

  • Conformity assessment by Notified Body 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 other category.


Products Limitations
*IVD 0100 – Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups
   – *IVD 0101 – ABO system
   – *IVD 0102 – Rhesus (C, c, D, E, e)
   – *IVD 0103 – Anti-Kell
*IVD 0200 – Reagents and reagent products, including related calibrators and control materials, for the detection, confirmation and quantification in human specimens of markers of
   – *IVD 0201 – HIV infection (HIV 1 and 2)
   – *IVD 0202 – HTLV I and II
   – *IVD 0203 – Hepatitis B, C and D
*IVD 0300 – Reagents, reagent products and devices for self-diagnosis, including related calibrators and control materials, for determining, detection, quantification, diagnosing, evaluating
   – *IVD 0301 – Anti-Duffy and anti-Kidd
   – *IVD 0302 – Irregular anti-erythrocytic antibodies
   – *IVD 0303 – Congenital infections: rubella, toxoplasmosis
   – *IVD 0304 – Hereditary disease: phenylketonuria
   – *IVD 0305 – Human infections: cytomegalovirus, chlamydia
   – *IVD 0306 – HLA tissue groups: DR, A, B
   – *IVD 0307 – Tumoral marker: PSA
   – *IVD 0308 – Risk of trisomy 21 (incl. software)
   – *IVD 0309 – Device for self-diagnosis: device for the measurement of blood sugar
*IVD 0400 – Devices for self-testing
   – *IVD 0401 – Clinical chemistry
   – *IVD 0402 – Haematology
   – *IVD 0403 – Immunology
   – *IVD 0404 – Molecular biology
   – *IVD 0405 – Pregnancy and ovulation
   – *IVD 0406 – Specimen receptacles
Horizontal technical competence Limitations
*MDS 7206 – IVDs in sterile condition
*MDS 7207 – IVDs utilising micromechanics
*MDS 7208 – IVDs utilising nanomaterials
*MDS 7209 – IVDs utilising biological active coating and/or material
*MDS 7210 – IVDs utilising material of human origin

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