The medical equipment area is under the responsibility of Medicines Agency in Denmark, Sweden and in most other EU countries. The technological development in this area is moving fast. A new regulatory framework for medical devices has been adopted by the EU Parliament on April 5, 2017. Introduction of new regulations has required transfer of the management of medical devices from the Norwegian Directorate of Health to the Norwegian Medicines Agency.
The transfer does not involve any change of responsibility or roles related to the prescription / Norwegian Health Economics Administration (HELFO) / reimbursement of medical devices. It also does not cover electromedical equipment under the responsibility of the Directorate for Social Security and Emergency Planning (Direktoratet for samfunnssikkerhet og beredskap).
See full details in the Norwegian here.
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