The European Commission has suggested revising the common specifications for certain class D in vitro diagnostic devices to address tests for specific parasites and viruses of public health importance. Stakeholders have a four-week period to provide feedback on these proposed changes.
On 19 August, the Commission released the proposed amendments, which, if approved, would update the In Vitro Diagnostic Medical Devices Regulation (Regulation (EU) 2017/746). According to the Commission, these amendments aim to include certain viruses and parasites that are currently not covered by the regulation but are significant to public health.
This includes Toxoplasma gondii and the Chikungunya and Zika viruses.
You can find out more information here.
Stakeholders can comment on the proposed amendments on the European Commission’s website until 16 September.
