Market control a task for The Swedish Medical Products Agency

The the medical devices legislation is supervised by The Swedish Medical Products Agency.

The Swedish Medical Products Agency is entitled to request information and review documentation as required, and to gain access to grounds, premises and other rooms where medical devices are kept or handled.

Monitoring activities include surveillance of manufacturers and distributors of medical devices. Manufacturers/distributors are obliged to facilitate and may have to defray the cost of investigations undertaken by Medical Products Agency: no compensation is paid for costs arising out of such activities or for samples taken. If hazardous or defective devices are discovered, Medical Products Agency can issue an injunction ordering a manufacturer, or other person, to provide warning information for the devices in question. Medical Products Agency may also prohibit or restrict the sale of such devices or demand that a problem is rectified or that a product is recalled.

The Swedish Medical Products Agency shall inform the EU Commission of any decision leading to a CE-marked device being stopped. This may lead to the recall of a device from the entire EEA market.

If a manufacturer is issued with an injunction to modify a device, this can mean that no more devices of that model may be sold until the problem is rectified, or that the device must be recalled for rectification. A recall normally indicates that all devices sold must be recalled. In order to reach all users, a manufacturer may also be required to publish warning advertisements.

Enforcement

The Swedish Medical Products Agency can combine injunctions and prohibitions with contingent fines. Those who transgress the Medical Devices Act and Regulations issued by the Swedish Medical Products Agency, can be fined or sentenced to imprisonment for a maximum of one year.

 

 

 
 
 
 

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