Health technology assessment of medical devices
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The Norwegian Medical Products Agency (NOMA) evaluates if medical devices are safe and effective, as well as the economics of introducing devices to clinical practice.
How are medical devices assessed?
The national system “Nye metoder” decides whether health technologies will be assessed and implemented in specialist health care services. Nye metoder collects input from clinicians and professionals in hospitals, which aid the commissioner in their decisions.
Medical devices may be assessed following a proposal or a horizon scan. Anyone may submit a proposal for assessment to Nye metoder. A horizon scan is a search by NOMA for novel medical devices that may be relevant in today's healthcare. We alert Nye metoder of devices we consider relevant and potentially beneficial.
Anyone can submit input and opinions on medical devices while NOMA is conducting a health technology assessment.
Health technology assessments
NOMA conducts various types of health technology assessments. In some cases, a manufacturer or their representative submits documentation for appraisal.
Read more about submitting documentation.
We also conduct health technology assessments without external submissions. Here we obtain, analyze and assess the relevant documentation ourselves.
In any case, we write a report on the medical device assessed. We routinely involve clinical experts and patient representatives in this work.
Implementation or discontinuation
Our health technology assessments do not include recommendations whether the device should be used or not. Our final report provides evidence that informs the decision by Nye metoder whether or not to introduce, retain or discontinue a medical device in the Norwegian health care system.
Three priorities influence decisions on using a health technology: 1) potential benefit of the technology, 2) use of resources and personell, and 3) the severity of the underlying medical condition. Our assessments include a consideration of criteria 1, 2 and 3, to ensure equitable access to health technologies and correct prioritization.