Registration

Swedish manufacturers and authorized representatives that manufactures/provides medical devices within the product groups listed below are required to register themselves and their products at the Swedish Medical Products Agency.

Registration has to be done to facilitate control of medical devices that are CE-marked by the manufacturer and placed on the market. It is the manufacturer of the medical device who reassure that the products in the registration fulfill the applicable requirements in the Swedish Act (1993:584) on medical devices and the Medical Products Agency regulations on Medical Devices LVFS 2003:11, alternatively LVFS 2001:7.

Note that a registration in register of the Swedish Medical Products Agency does not mean that the Medical Products Agency has approved the products.

The Swedish Medical Products Agency has the possibility to decide on market prohibition for products that do not fulfill applicable requirements. It may for example occur when a product is stated to be CE-marked as a medical device but does not fulfill the definition of a medical device under the Act (1993:584). It may also occur when a medical device is incorrectly classified according to the rules in 2003:11 or 2001:7.

Other countries within the EEA have also registration requirements. Information registered with the responsible national authorities is passed on to a central European database, EUDAMED, which is available only for competent authorities. This creates, in addition to a European market overview also opportunities for follow-up of accidents, incidents and other anomalies that may affect patient or user safety. EUDAMED is open only for the Medical Products Agency and other agencies within EES.

Registration requirements

All Swedish manufacturers and authorized representatives of the following products shall sign up for registration with the Swedish Medical Products Agency:

  • in vitro diagnostic products
  • medical devices in class I, Is and Im
  • custom-made medical devices
  • module and procedure packs
  • national medical information systems (NMI)

Registration is made on the forms provided and designed according to the instructions that may be found in the Swedish website.

Comments

Until further notice, Sweden does not require that manufacturers/authorized representatives register medical device in Class IIa, IIb or III placed in service in Sweden (comparable provision in the MPA regulations on medical devices, LVFS 2003: 11 § 9 point 3 / Directive 93 / 42 / EEC Article 14 § 1).

Distributors should not register themselves or their products at the Swedish Medical Products Agency.

 
 
 

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