Impact of the European regulation on medical devices, seen from Switzerland

By Guillaume Promé
Sep. 19, 2022 Regulation (EU) 2017/745

Swiss Medtech (industry association for Swiss medical technology) publishes its Medtech sector study 2022. This article summarizes the impact of MDR on Swiss manufacturers

This – very detailed – study includes manufacturers, distributors and suppliers (goods or services); it addresses the economic, strategic, technological and environmental aspects of MD sector.

  • Switzerland has become a third country for Europe due to the lack of a regulatory agreement
  • This status causes shortages of MD for 82% of importers and distributors
  • 20% of manufacturers plan to create jobs in R&D
  • 53% of manufacturers plan to create jobs in AR/QA.
  • MDR compliance increases R&D costs by 12%, for 79% of manufacturers
  • DM prices increase by 6%, on average
  • 63% of manufacturers are reducing their product portfolio (13% reduction, on average)
  • Increasing quality and documentation requirements is elected “Top challenge for medtech companies”
  • Uncertainty with legal interpretations is elected “Top difficulty for manufacturers”
  • Increase product prices is voted “Top priority for manufacturers, suppliers and distributors”
  • An image summarizes the evolution of access to different markets:

accès aux marchés du DM, évolution des difficultés

Source : Swiss Medtech