Submission of documentation for single technology assessment of medical devices
Published:
Changes
- : Minor text edits and hyperlinks replaced
- : Endringer i tekst. Lenker til nye dokumenter og maler.
Medical device developers may submit documentation to NOMA for appraisal of a health technology. We ask to use our updated guideline and templates for submission below. Please contact us at hta.medical.devices@noma.no for any questions.
The national system Nye metoder decides whether a medical device will be offered by specialist health care services. They will commission NOMA for an assessment of the relevant health technology prior to implementation.
At NOMA, we conduct different types of health technology assessments. For a single technology assessment, NOMA may request documentation from the device developer, manufacturer, distributor or representative, who will conduct and submit analyses for appraisal.
Only medical devices that carry the CE mark of conformity are eligible for assessment.
Guideline
Please find our guideline (PDF) and template for submission (DOCX) below.
Submission guideline (medical device) (PDF)
The guideline document is available in English only and should only be used for single technologies offered by specialist healthcare services through the national system (see above).
This guideline replaces previous guidelines by the Norwegian Institute of Public Health. From March 1, 2025, we no longer accept outdated templates.
Templates
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Template for submission (DOCX)
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Template for budget impact analysis of medical devices used by individual patients (XLSX)
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Template for budget impact analysis of medical devices used by multiple patients (XLSX)
Norwegian EQ-5D-5L tarif from September 1
NOMA has updated their guideline for single health technology assessements. As of September 1, 2025, applications must be based on the EQ-5D-5L value set for Norway (Garratt et alia, 2024) when documenting health-related quality of life for adults. Applications submitted before September 1, 2025, may still use the previous guideline.
Adapting the novel EQ-5D-5L value set for Norway implies updated adjustments for severity and age. Our tool for severity adjustment and age adjustment (above) is updated.
Clarification of documentation requests
NOMA offers assistance with preparing documentation prior to submission. Read more about these meetings here.
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.