On 15-June-22, the HPRA released a guide on how to Performance Studies Conducted in Ireland.
The term ‘performance study’ (PS) is defined in the IVDR as a study undertaken to establish or confirm the analytical or clinical performance of a device. It should be noted that this definition includes the use of non-CE marked and CE marked devices. Specific articles of the IVDR detail the expectations for different types of PS.
See the Decision tree to assist in determining performance study application/notification requirements.
This guide provides an introduction to legislation and key concepts relevant to performance studies (PS) on in vitro diagnostic medical devices (IVDs), as well as how applications are submitted to the Health Products Regulatory Authority (HPRA).
This guide is targeted at PS sponsors (e.g. manufacturers, academic groups, clinical research organisations) who wish to conduct PS involving IVDs in Ireland. The information may also prove useful for ethics committees and other stakeholders.
Click this LINK to know in detail about this guidance.