Submission of documentation for single technology assessment of medical devices

The national system “Nye metoder” decides whether a medical device will be implemented by specialist health care services. Prior to their uptake, they will commission a health technology assessment by NOMA.

At NOMA, we conduct different types of health technology assessments. Single technology assessments are based on documentation provided by the device developer, manufacturer, distributor or their representative.

For a single technology assessment, NOMA may request documentation from the manufacturer, who will conduct and submit their analyses to us 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 From March 1, 2025, we will no longer accept outdated templates for documentation.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.

Pre-meetings

NOMA offers pre-meetings prior to submission of documentation. Read about pre-meetings here.