Guideline for Registration of Medical Devices in Sweden  

Article No. 42282

Description

This guideline describes the registration of medical devices in Sweden.

Categories

Sub Categories

Market

Synopsis

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.