Health technology assessment of medical devices
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The Norwegian Medical Products Agency evaluates if medical devices are safe and effective, as well as the economics of using them in specialist clinical practice.
From commission to decision
The national system Nye metoder decides whether a health technology will be assessed for use in specialist healthcare services. Nye metoder will receive suggestions of medical devices for implementation or discontinuation as follows:
- Manufacturers or their legal representatives can suggest their devices to be assessed. Non-commercial entities, clinicians as well as private actors, can submit their suggestion for assessement of a medical device to Nye metoder. Read more about Nye metoder and how to submit a proposal (webpage in Norwegian).
- Sykehusinnkjøp or regional requisition bodies can ask for health technologies to be assessed prior to public requisition and implementation.
- In addition, devices that have been assessed under the EU regulation on health technology assessment (HTAR) will also be assessed on the national level.
Bestillerforum for nye metoder (webpage in Norwegian) will commission a HTA from NoMA, in some cases also price assessment from Sykehusinnkjøp, before medical devices are implemented. Devices have to fulfill certain criteria and, as a general rule, must not be used until they have been assessed and public funding has been decided. Read more about the commissioner's criteria for assessment of medical devices.
Anyone can submit their opinion or input on a health technology commissioned for assessment. In addition, Nye metoder will seek advice from clinical experts and health professional organizations.
Assessment before implementation
NOMA conducts different types of HTA. In some cases, a manufacturer or their representative will submit documentation for appraisal. Read more about submitting documentation.
We also conduct HTA without external submissions. Here, we obtain, evaluate and analyze any relevant documentation ourselves. We routinely involve clinical experts and patient representatives before and during an HTA.
Our assessments provide evidence that informs Beslutningsforum for nye metoder (webpage in Norwegian) whether or not to introduce, retain or discontinue a medical device in the Norwegian health care system.