Health technology assessment of medical devices
Published:
Changes
- : Endringer i tekst
- : Minor text edits
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.
Who decides which medical devices are being used?
The national system Nye metoder decides whether a health technology will be assessed for use in specialist healthcare services. Nye metoder collects input from clinicians and professionals in hospitals, which aid the commissioner in their decision.
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 useful. 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 (see below).
Assessment before implementation
NOMA conducts different 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.
We routinely involve clinical experts and patient representatives in this work. In every case, we write a detailed report about the medical device assessed.
Our assessments provide evidence that informs Nye metoder whether or not to introduce, retain or discontinue a medical device in the Norwegian health care system. They do not include recommendations whether the device should be used.
Access to health technologies
Our reports include a consideration of the following three criteria that may influence the decision on whether to implement or not or phase out a medical device: 1) potential benefit of the technology, 2) use of resources and personell, and 3) severity of the underlying medical condition. In this way, health technology assessments ensure patients' equitable access to health technologies.