Element card for assessment element A0020 in HTA Core Model Application for Diagnostic Technologies (1.1) application

A. Health Problem and Current Use of the Technology

Regulatory Status

Which approval status has the technology in other countries, or international authorities?


Imaging devices may require approval. In addition, substances needed for the obtention of images may require additional approval (e.g. radiotracers)

e.g. CE-Approval, EMEA, national authorities. Manufacturers should be contacted in order to identify which steps have they taken/ are they planning to take concerning market approval


Legal Domain

Burls et al. 2001, Busse et al. 2002, Liberati et al. 1973 Imaz-Iglesia et al. 1998, Kristensen et al. 2009