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August 16, 2022
Big News for AllTest!
Since the IVDR regulation came into effect on May 26, 2022, the AllTest team has successfully completed IVDR registration of rapid test products and instruments used for IVD testing in just under three months.
The new EU IVDR regulations focus more on clinical performance, better traceability of medical devices and greater transparency to patients. At the same time competence and experience will be important indicators for the review. The success of IVDR registration means that we cannot do without the efforts of everyone in our team, and it also proves that the quality of our products is excellent and meets all import and export standards.
According to the risk level of the products from low to high: Class A, B, C, D
Class D: Used to detect the presence or exposure of infectious agents in blood, blood products, cellular tissues or organs to assess suitability for blood transfusion, transplant cell processing.（e.g.:HBV/HCV/HIV Viral load Kit）
Class C: Blood typing or tissue typing. Those that ensure the immunological compatibility of blood, blood products, cellular tissues used for transfusion, transplantation or cellular processing are classified as Class C.(e.g.: HLA typing Kit, HLA sequencing analysis software)
Class B (Device Class): These are products whose incorrect results may not have a greater negative impact on the patient, result in death or severe disability, or place the person in immediate danger.
Class A: 1) Products or accessories that are commonly used in laboratories by manufacturers specifically for specific in vitro diagnostic procedures. For example: cleaning solution, buffer, diluent, common culture medium.
2) Instruments used for IVD, PCR thermal cycler, hematology analyzer, etc.