In Vitro Diagnostic Device Regulation (IVDR)

The aim of In Vitro Diagnostic Device Regulation (IVDR) is:

  • Ensure the smooth functioning of the internal market as regards in vitro diagnostic medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small and medium-sized enterprises that are active in this sector.
  • Set high standards of quality and safety for in vitro diagnostic medical devices in order to meet common safety concerns as regards such products.

IVDR has led to major or minor changes in areas such as:

  • supervision of notified bodies,
  • risk classification,
  • conformity assessment procedures,
  • performance evaluation and performance studies,
  • vigilance and market surveillance,
  • transparency and traceability.