State Institute for Drug Control

The priority of Medical Devices is to support the transformation of requirements stipulated by the directives of the European Community in the area of medical devices. The employees of Medical Devices are involved in the work of a number of commissions and working groups active in the area of standardisation, accreditation systems, quality systems, such as e.g. ISO/TC194, CEN/TC206, CEN/TC316, and TNK81, and the area of standards of the EN 45 000, ISO 9000 series. The department is involved in the following activities:

1. Investigation and evaluation of adverse incidents of medical devices pursuant to Section 40, paragraph (2), letter c) and inspections of the conduct of clinical evaluations or clinical trials on medical devices as stipulated by Act No 123/2000 Coll., on Medical Devices, as amended;
2. Inspections of the conduct of clinical evaluations at healthcare providers´ and mandatory requirements governing sites where a clinical evaluation of a medical device is to be conducted, as stipulated by Section 40, paragraph (2), letter a), items 4. and 5., of Act No 123/2000 Coll., on Medical Devices, as amended;
3. Inspections at healthcare providers´, in particular of the conduct of maintenance and repairs, record-keeping and documentation of medical devices, of Instructions for Use (IFUs), records about trainings, periodic controls, and adverse incidents pursuant to Section 40, paragraph (2), letter a), items 1.,2.,3. and 6., letter b) and letter d) of Act No 123/2000 Coll., on Medical Devices, as amended.