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.