Health technology assessment of medical devices
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The Norwegian Medical Products Agency (NOMA) assesses evidence on effectiveness and safety of medical devices, in addition to conducting health economic assessments of for introducing the device into clinical practice.
How are medical devices selected for assessment?
Health technology assessments are commissioned by the national system of managed introduction of new methods in the specialist health care service in Norway (“Nye metoder”).
In the case of medical devices, this may happen in one of two ways: anyone can submit a proposal. In addition, through horizon scanning, NOMA regularly searches for new medical devices that may be relevant for the healthcare services. We alert Nye metoder of devices we consider relevant and potentially beneficial.
Anyone can submit input and opinions on the proposed medical device. Nye metoder collects input from clinicians and professionals in the hospitals, which aid the commissioner in deciding whether NOMA should conduct a health technology assessment.
Types of health technology assessments
NOMA conducts various types of health technology assessment of medical devices. In some cases, a manufacturer or their representative submits documentation for appraisal.
Read about submission of documentation here.
We also conduct health technology assessments without industry submission. Here we obtain, analyze and assess the relevant documentation. In all cases, we write a report on the medical device assessed. We routinely involve clinical experts and patient representatives in our work.
Decision on introduction or disinvestment
Our health technology assessments do not include recommendations on implementation. Our report provides evidence that inform decision makers whether to introduce, retain or discontinue the medical device in question.
The priority setting in Norwegian health care system is based on the following principles: potential benefit of the technology, resource use and the severity of the medical condition. Health technology assessments may aid decisions on whether the prioritization criteria are fulfilled.