The role of the National Board of Health and Welfare is determined by the Medical Devices Act and Ordinance. The Board s responsibilities include putting statutory regulations into place and monitoring their effectiveness through market control. During the transitional period when manufacturer s are permitted to follow either older Swedish or Swedish EU regulations, the Medical Products Agency retaines regulatory responsibilities for factory sterilized disposables and contraceptives. This brochure is primarily intended for manufacturers and suppliers of medical devices and gives a summary of the legislation in force since 1 January 1995. One procedure for EU-countries Every day numerous medical devices are used in health care facilities and elsewhere all over Sweden.
Most devices are quite simple, while others are complex and combine different technologies.
Defects or disturbances in the functions of medical devices may expose patients to serious risks. This is particularly true for devices which transfer energy or pharmaceuticals to patients, e.g infusion pumps, or devices which sustain or support vital functions, e.g pacemakers. Nonetheless the safety standards must be high for all medical devices. The devices shall be safe and reliable and well suited for their intended purposes. Sweden has brought its legislation in line with the safety requirements in force within the EU concerning testing, certification and labelling of medical devices.