Implementing Regulation (EU) 2022/1107 laying down common specifications for Class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746

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.

DOWNLOAD THE IMPLEMENTING REGULATION (EU) 2022/1107