Medical devices illustration

Market surveillance programmes

Market surveillance programs

Market surveillance means the surveillance of compliance of products and services with legislation carried out by public authorities in the internal market of the European Union. Market surveillance takes place in retrospect in the market on the basis of risk assessments.

Market surveillance conducted by authorities helps to verify compliance with the provisions laid down in legislation and to ensure that there are no dangerous or non-compliant products on the market. In addition to safety requirements, market surveillance also covers the surveillance of other characteristics, such as those related to environmental protection.

The market surveillance programmes falling under the area of responsibility of the Finnish Medicines Agency Fimea by relevant legislation are as follows:

Market surveillance programme for medical devices

  • Active Implantable Medical Devices Directive (90/385/EEC)
  • Medical Device Directive (93/42/EEC)
  • In Vitro Diagnostic Medical Devices Directive (98/79/EC)

Read more about market surveillance:

Market surveillance programmes (Ministry of Employment and the Economy)

Market surveillance (Ministry of Employment and the Economy)

Regulation (EC) No 765/2008 of the European Parliament and of the Council