Obligation to Report Certain Special Procedures

Custom-made devices

Swedish manufacturers or authorised representatives of custom-made devices shall apply for registration with the Swedish Medical Products Agency. A custom-made device is defined as a device placed on the market and manufactured specifically in accordance with the written prescription of e.g. a physician or a physiotherapist and which is intended for use by a specific patient. The device shall comply with the essential requirements but no CE-marking shall be affixed.

Devices for clinical investigation

Clinical investigations of medical devices undertaken in order to establish properties of importance for the possibility to CE-mark the device shall be notified to the Swedish Medical Products Agency. A product under such investigation shall not carry the CE-mark but have the inscription “Exclusively for clinical investigation”. The device shall comply with the essential requirements apart from aspects covered by the investigation. 

Devices put into service before 1998

Devices  put into service before June 14, 1998, are not covered by the Regulations. However, they are covered by the Medical Devices Act and Ordinance.

In-house manufactured devices

In-house manufactured devices, i.e. devices which are not meant to be placed on the market and which are manufactured within a health care facility for use on the premises/within the organisation, are not covered by Regulations LVFS 2001:5, LVFS 2003:11 or LVFS 2001:7. Instead, these devices are covered by SOSFS 2001:12 entitled Responsibility for Medical Devices Within the Health Care Sector etcetera.

If such devices are manufactured within a hospital, the hospital is considered to be a manufacturer and to have responsibilities as set out in the Regulations.

Medicinal products

If a product exerts its primary effect through pharmacological, immunological or metabolic means, it is not considered to be a medical device. These products are instead regulated in the Swedish Medicinal Products legislation or in other legislation.

 

 

 
 

Related information

 

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