In order to provide appropriate provisions regarding Class D in vitro diagnostic medical devices, the European Commission has adopted the Implementing Regulation (EU) 2022/1107. It establishes common specifications for these devices with respect to their performance characteristics in accordance with Annex I of Regulation (EU) 2017/746.

This regulation includes definitions, common general specifications but also requirements specifically applicable to devices intended for the detection or quantification of (for instance):

  • Human immunodeficiency virus (HIV)
  • SARS CoV-2 virus
  • Epstein-Barr virus (EBV)
  • Treponema pallidum

This regulation shall enter into force on the twentieth day following its publication, i.e. July 25, 2022, and shall apply from July 25, 2024. Note that Article 3 is applicable as of July 25, 2022.



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