Legislation - Medical Devices

  • The Medical Devices Act (1993:584)
    The Medical Devices Act 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 Directive on active implantable medical devices (90/385/EEC), the Directive on medical devices (93/42/EEC) and the Directive on in vitro diagnostic medical devices (98/79/EG).
  • The Medical Devices Ordinance (1993:876)
    The Ordinance extends the provisions set forth in the Act; among other things, the Swedish Medical Products Agency is authorised to issue Regulations. The Ordinance entered into force on 1 July 1993. It also includes information on applicable fees for registration etc.
  • The Regulations issued by the Swedish 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  

The responsibility within the health care sector to report accidents and near-accidents with medical devices is regulated in SOSFS 2008:1.

 

 
 

Related links

Regulations for medical devices (all in Swedish):

 

External links

   
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information