European Commission proposes common specifications for IVDs for parasites, viruses

The European Commission has proposed updating common specifications for certain class D in vitro diagnostic devices to consider tests for certain parasites and viruses that are of public health concern. Stakeholders have four weeks to comment on the proposed amendments.

On 19 August, the Commission published the proposed amendments that, if finalized, would update the In Vitro Diagnostic Medical Devices Regulation (Regulation (EU) 2017/746). The Commission said the amendments are intended to include certain viruses and parasites not already considered in the regulation that are of public health importance.

"For class D devices intended for detection of hepatitis E virus, Toxoplasma gondii, Plasmodium spp., as well as four types of arboviruses (Chikungunya virus, dengue virus, West Nile virus and Zika virus), harmonized standards do not exist as regards certain requirements of Annex I to Regulation (EU) 2017/746, and there is a need to address public health concerns, as the risk associated with the use of those devices is significant for public health and patient safety," said the Commission. "The experience with the use of common specifications laid down in Implementing Regulation (EU) 2022/1107, has demonstrated that there is a need to clarify some of those specifications or, where necessary, update them to reflect the state of the art."

While the Commission said sponsors, manufacturers, notified bodies, and other stakeholders need time to transition to the new regulations, they may also voluntarily start complying with the changes before they have been finalized. It also noted that it had consulted with the Medical Device Coordination Group (MDCG) and the changes comply with the opinion of the Committee on Medical Devices.

The Commission also published an Annex detailing qualitative and quantitative requirements for Nucleic Acid Amplification Technique (NAT) devices for detecting hepatitis E and several arboviruses.

The Annex notes that target sequence amplification devices used to detect the RNA of the viruses in question will require a functionality control for each specimen that is considered the state of the art and used throughout the test process including during extraction, amplification, and detection. The ability to detect genotype and/or subtype should be demonstrated with the right primer or probe design validation and be validated by testing characterized genotyped specimens.

"Potential cross-reactivity of non-target nucleic acid sequences shall be analyzed by appropriate primer or probe design validation and shall also be validated by testing selected specimens," said the Commission. "Results of quantitative NAT devices shall be traceable to international standards or reference materials calibrated against those international standards, if available, and be expressed in international units utilized in the specific field of application."

The Annex also details requirements for devices used to detect certain parasites, such as Plasmodium spp., which causes malaria. It includes performance characteristic requirements for the tests, including their diagnostic and analytical sensitivities, diagnostic specificity, and cross-reactivity.

Stakeholders can comment on the proposed amendments on the European Commission's website until 16 September.

European Commission proposes common specifications for IVDs for parasites, viruses

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