Authorization

  • Authorization for the performance of microbiological examinations for the detection or exclusion of transmissible human diseases
  • Authorization to conduct diagnostic or epidemiological investigations in the field of human communicable diseases.
  • Authorization to perform microbiological testing on blood, blood products or transplants to rule out transmissible diseases with a view to transfusion, transplantation or processing.

Declaration on in vitro diagnostic medical devices

Declaration according to Art. 5, para. 5 let. f. of Regulation (EU) 2017/746 on in vitro diagnostic medical devices

 

Declaration_IVDR_ifik_V1 (PDF, 217KB)