Class D in vitro diagnostic devices: expert panel views

The European Medicines Agency (EMA) publishes the views of the in-vitro diagnostics expert panel on Class D in vitro diagnostic devices. It also publishes information on ongoing consultations.

The in-vitro diagnostics expert panel delivers these opinions as part of the performance evaluation consultation procedure (PECP). The legal basis is Article 48(6) of Regulation (EU) 2017/746.

More information:

• Consultation procedures for high-risk medical devices
• Medical device expert panels
• Class III implantable devices and Class IIb medical devices: expert panel opinions

Expert panel views

Fetal RHD status - Notified body 2962 - 24/4/2024 - View in the context of the performance evaluation consultation procedure (PECP)

Plasmodium DNA and RNA - Notified body 2797 - 18/02/2024 - View in the context of the performance evaluation consultation procedure (PECP)

Anti-HEV IgM - Notified body 0459 - 19/10/2023 - View in the context of the performance evaluation consultation procedure (PECP)

Anti-HEV IgG - Notified body 0459 - 19/10/2023 - View in the context of the performance evaluation consultation procedure (PECP)

Glycoprotein (GP) gene and/or nucleoprotein - Notified body 2797 - 05/09/2022 - View in the context of the performance evaluation consultation procedure (PECP)

Antibodies to Treponema pallidum - Notified body 0123 - 03/02/2022 - View in the context of the performance evaluation consultation procedure (PECP)

IgG antibodies to Epstein-Barr Virus (EBV) Viral Capsid Antigen (VCA) - Notified body 0123 - 16/02/2022 - View in the context of the performance evaluation consultation procedure (PECP)

Determination of IgG antibodies to SARSCoV-2 - Notified body 0123 - 04/02/2022 - View in the context of the performance evaluation consultation procedure (PECP)

Determination of IgM antibodies to SARS-CoV-2 - Notified body 0123 - 03/02/2022 - View in the context of the performance evaluation consultation procedure (PECP)

Antibodies to Trypanosoma cruzi - Notified body 0123 - 26/01/2022 - View in the context of the performance evaluation consultation procedure (PECP)

SARS-CoV-2 RdRp, E and N genes - Notified body 2797 - 20/01/2022 - View in the context of the performance evaluation consultation procedure (PECP)

IgG and IgM antibodies Treponema pallidum - Notified body 2797 - 12/01/2022 - View in the context of the performance evaluation consultation procedure (PECP)

SARS-CoV-2 ORF1 a/b non-structural region and nucleocapsid protein gene & Influenza A matrix gene & Influenza B non-structural protein gene - Notified body 2797 - 10/01/2022 - View in the context of the performance evaluation consultation procedure (PECP)

Antibodies (including IgG) to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) - Notified body 0123 - 14/12/2021 - View in the context of the performance evaluation consultation procedure (PECP)

Chikungunya virus (CHIKV) RNA and dengue virus (DENV) RNA - Notified body 2797 - 10/12/2021 - View in the context of the performance evaluation consultation procedure (PECP)

Zika Virus RNA - Notified body 2797 - 09/12/2021 - View in the context of the performance evaluation consultation procedure (PECP)

Babesia (B. microti, B, duncani, B. divergens, and B. venatorum) DNA and RNA - Notified body 2797 - 19/11/2021 - View in the context of the performance evaluation consultation procedure (PECP)

West Nile Virus (WNV) RNA - Notified body 2797 - 12/11/2021 - View in the context of the performance evaluation consultation procedure (PECP)

Hepatitis E virus (HEV) - Notified body 2797 - 08/11/2021 - View in the context of the performance evaluation consultation procedure (PECP)

Parvovirus B19 genotypes 1, 2, and 3 DNA & Hepatitis A virus (HAV) genotypes I, II, and III RNA - Notified body 2797 - 22/11/2021 - View in the context of the performance evaluation consultation procedure (PECP)

Ongoing consultations

EMA publishes the completed consultation request templates that have been submitted by notified bodies for ongoing procedures to the in vitro device expert panel. These contain information on the type of device that is under consultation.

There are currently no ongoing consultations.