Submission of documentation for single technology assessment of medical devices

These are commissioned by the national system for the introduction of health technologies in the specialist healthcare services (“Nye metoder”). The health technology assessments serve as the basis for decisions about implementation of the health technology in the specialist healthcare.

Some health technology assessments are carried out based on documentation provided by the medical device manufacturer (or their representative). In these cases, NoMA contacts the manufacturer, and they conduct analyses and submit documentation to NoMA.

Manufacturers can contact the NoMA via hta.medical.devices@noma.no for information on the process of submitting documentation, as well as guidelines and templates.

To be eligible for health technology assessment, the medical device must have the CE mark of conformity. Submitted documentation may be in English, Norwegian, Danish, or Swedish.