- The Act (1993:584) Medical Devices
The Act on Medical Devices entered into force on 1 July 1993. The Swedish Act is harmonised with the EC Directives. In addition to general regulations that pertain to the sector, it incorporates key provisions in the EC Directive on active implantable medical devices (90/385/EEC), the Directive on medical devices (93/42/EEC) and the proposal for a Directive on in vitro-diagnostic medical devices (98/79/EG).
- The Ordinance (1993:876) on Medical Devices
The Ordinance extends the provisions set forth in the Act; among other things, Medical Products Agency is authorized to issue Regulations. The Ordinance entered into force on 1 July 1993. It also includes information on applicable fees for registration etc.
- Regulations from Medical Products Agency
Detailed regulations for active implantable medical devices are found in LVFS 2001:5, for medical devices in LVFS 2003:11 and for in vitro-diagnostic medical devices in LVFS 2001:7
Manufacturers' obligation to report accidents and near-accidents with medical devices, LVFS 2001:8.
Responsibility for medical devices within the health care sector etcetera, SOSFS 2001:12.