European Commission Proposes New Standards for High-Risk Diagnostic Devices Targeting Parasites and Viruses

The European Commission’s proposal for new common specifications for certain high-risk in vitro diagnostic devices (IVDs) reflects an ongoing effort to standardize and ensure the safety and effectiveness of these critical tools under the In Vitro Diagnostic Regulation (IVDR) 2017/746. These specifications particularly target Class D IVDs, which are used to detect a range of pathogens that pose significant public health risks.

Key Aspects of the Proposal:

Targeted Pathogens: The specifications focus on IVDs that detect:

Viruses: Hepatitis E, Chikungunya, dengue, West Nile, Zika, hepatitis B, hepatitis C, hepatitis D, HIV, human T-cell lymphotropic virus (HTLV), cytomegalovirus, Epstein-Barr virus, SARS-CoV-2, and others.

Parasites: Toxoplasma gondii and Plasmodium species (which cause malaria).

Blood Grouping Antigens: Specifications also cover blood group antigens within the ABO, Rh, Kell, Duffy, and Kidd systems.

Rationale for the Proposal: The Commission has identified gaps in harmonized standards for these IVDs, particularly those related to emerging or less common pathogens like Toxoplasma gondii and Plasmodium spp., and various arboviruses. The proposal aims to fill these gaps by providing clear and harmonized specifications that manufacturers must adhere to.

Consultation and Implementation:

The European Commission has opened a four-week public consultation period, from August 19 to September 16, 2024, allowing industry stakeholders, healthcare professionals, and other interested parties to provide feedback on the proposed specifications.

The consultation is part of a broader effort to refine and implement the IVDR, ensuring that these diagnostic tools meet rigorous safety and performance standards.

Transitional Period: To allow manufacturers and other stakeholders time to adjust, the proposal includes a transitional period. This will enable a smoother adoption of the new specifications without disrupting the availability of these crucial diagnostics.

Harmonization and Clarification: Beyond introducing new specifications, the proposal also seeks to clarify certain aspects of existing regulations, ensuring that they are applied consistently across the EU. This harmonization is crucial for maintaining the integrity and reliability of diagnostic testing, which is essential for public health. This initiative is part of the European Commission’s broader strategy to strengthen the regulation of medical devices and diagnostics across the EU, enhancing the safety and reliability of products available on the market. The updates to the IVDR are particularly significant as they address emerging health threats and ensure that the EU’s regulatory framework keeps pace with technological advancements and public health needs