Accreditations and conformity assessment bodies
The subject field of in-vitro diagnostics deals in particular with the accreditation of bodies that test in-vitro diagnostics, which are then mainly used in medical laboratory diagnostics.
The subject field of medical devices deals with the accreditation of conformity assessment bodies that test medical devices, such as implants, raw materials and cleaning and disinfection equipment. Accreditations in this subject area are carried out on the basis of DIN EN ISO/IEC 17025. They currently cover only areas in which accreditations are applied for voluntarily.
Benefits of accreditation
The accreditations granted in these areas certify that the tests are carried out competently. In accordance with the requirements of the German Accreditation Body Act, this department works closely together with the Central Authority of the Federal States for Health Protection (ZLG) with regard to medicinal products and medical devices.