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.