Sweden has since 1993 a comprehensive law that specifies requirements for medical devices placed on the market. The base of this regulation is available in the act (1993:584) concerning medical devices and the regulations published by the Medical Products Agency. Our certificates can be found here:
EC certificate valid until 26 May 2024
Certificate ISO 9001:2015 valid until 2023-09-25
Declaration of Conformity Sports & Medical
Declaration of Conformity Monark Medical Treadmill 2017-10-04
