Guideline for Registration of Medical Devices in Sweden  

Article No. 42282


This guideline describes the registration of medical devices in Sweden.


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The registration is made to facilitate the Swedish Medicines Agency’s control of the medical technology products that have been CE-marked and placed on the market by the manufacturer. It is the manufacturer of a medical device that ensures that the products covered by the notification meet the applicable requirements in the Medical Devices Act and the Swedish Medicines Agency’s regulations.