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Sweden

Regulatory Agency

The medical device regulatory authority in Sweden is the Swedish Medical Products Agency (MPA).

Medical Device Definition

Medical Device: means any instrument, apparatus, appliance, software, implant, reagent, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used for diagnostic or therapeutic purposes and which is program support necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

  • diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease;
  • diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or disability;
  • investigation, replacement or modification of an anatomical structure or function or of a physiological or pathological process or state;
  • providing information by means of in vitro investigation of specimens from the human body, including organs, blood and tissues donations;
  • control or facilitation of conception;
  • cleaning, disinfection or sterilization of medical devices.

Medical Device Classification System

Classification Risk Level Examples
l Low Risk Wheelchairs, Stethoscopes, Spectacles
IIa Medium Risk Dental fillings, Surgical clamps, Tracheotomy tubes
IIb Medium High Risk Lung ventilators, Bone fixation plate, Condoms
III High Risk Pacemakers, Heart valves, Implanted Cerebral Simulators

Regulatory Approval Process

Classification

Approval Procedure

I

 

 
  1. Manufacturers of class I products certify through their declaration of conformity that the product meets the requirements of the regulations.
  2. However, involvement of a notified body is required for products such as; has a measuring function (class Im), which is released on the market as a sterile product (class Is) or is a reusable surgical instrument (class Ir).

Ila

llb
  1. Products in class IIa or IIb must be inspected by a notified body.
  2. In order to CE‍-‍mark the product, the manufacturer can choose between two options:
    • The notified body carries out a type check of the product in combination with quality assurance of the production. For class IIb implants, assessment of the technical documentation must be applied for each product.
    • Conformity assessment based on a quality management system and an assessment of the technical documentation and assessment of the technical documentation for at least one representative product for each product category

lll
  1. In order to CE‍-‍mark the product, the manufacturer can choose between two options:
    • Assessment of conformity based on a quality management system and an assessment of the technical documentation.
    • The notified body carries out a type check of the product in combination with quality assurance of production.
  2. Special assessment:
    Measurement function: Assessment of the aspects related to the products’ compliance with the measurement technical requirements. Sterile: Assessment of the aspects related to creating, ensuring and maintaining the sterile conditions.
    Reusable surgical instruments: Assessment of the aspects related to cleaning, disinfection, sterilization, maintenance and functional testing of reusable surgical instruments and related instructions for use.

For certain products in classes III and IIb, the notified body consults an expert panel with regard to the clinical evaluation before the products can be CE‍-marked and placed on the market.

Additional Information

Approval Timeline

Not specified by the agency

License validity period

5 years

Fees
  • Manufacturers of and authorized representatives (AR) for medical devices (including specially adapted products) with operations in Sweden must pay a fee.
  • During a transition period, different fees will apply depending on whether the products have been placed on the market according to the MDR/IVDR regulations or according to the transitional provisions of the regulations.
  • Manufacturers and AR with operations in Sweden must pay an annual fee.
  • The annual fee will continue to be charged when registration is to take place in the European database Eudamed.

Products according to transitional regulations

Manufacturers and AR for manufacturers of legacy products incur fees as below.

Service

Charge

Registration of a maximum of 10 products

SEK 1,000/year

Registration of a maximum of 100 products

SEK 2,000/year

Registration of a maximum of 500 products

SEK 5,000/year

Registration of more than 500 products

SEK 10,000/year
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