Submission of documentation for single technology assessment of medical devices

Health technology assessments are commissioned by the national system for the introduction of health technologies in the specialist healthcare services (“Nye metoder”).

We conduct various types of health technology assessments. Single technology assessments are based on documentation provided by the device developer (manufacturer or their representative).

NOMA will contact the manufacturer and request documentation. The manufacturer will conduct and submit the necessary analyses to NOMA for appraisal. Only medical devices that carry the CE mark of conformity are eligible for assessment.

Guideline

Please use our guideline (PDF) and template for submission (DOCX). The guideline document is only available in English.

This guideline should only be used for implementation of a single technology in specialist healthcare services through the national system (see above).

The guideline replaces previous guidelines by the Norwegian Institute of Public Health. From March 1, 2025, we will no longer accept outdated templates for documentation.  

Templates

• Template for submission (DOCX)

• Template for budget impact analysis of medical devices used by individual patients (XLSX)

• Template for budget impact analysis of medical devices used by multiple patients (XLSX)

• Tools for severity adjustment and age adjustment (XLSX)

Submission

We accept submissions in English, Norwegian, Danish and Swedish. Please submit by email to both post@noma.no and hta.medical.devices@noma.no.

For questions about the guideline or further instructions on submission, please contact NOMA at hta.medical.devices@noma.no.