The Commission is proposing to amend Implementing Regulation (EU) 2022/1107 to add new common specifications for Class D IVDs. As a result, they have published a draft of the amended text and are soliciting industry feedback.

The information is available: HERE

Overview

The proposed new common specifications are for Class D devices intended for:

• Detection or quantification of markers of hepatitis E virus (HEV) infection
• Detection or quantification of markers of Toxoplasma gondii infection
• Detection of markers of Plasmodium infection
• Detection or quantification of markers of Chikungunya virus (CHIKV) infection
• Detection or quantification of markers of dengue virus (DENV) infection
• Detection or quantification of markers of West Nile virus (WNV) infection
• Detection or quantification of markers of Zika virus (ZIKV) infection

Once finalized, the legislation will enter into force on the 20^th day following its publication in the Official Journal of the EU. And apply two years after the date of entry into force.

Feedback period

You may provide your comments starting today (19 August 2024) through Monday 16 September 2024 (midnight Brussels time).