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Irelands HPRA MD Guide: Performance Studies Conducted in Ireland

Irelands Health Products Regulatory Authority (HPRA) released (16- November-2022) guide on "Performance Studies Conducted in Ireland", to provide an overview of legislation and key concepts relevant to performance studies (PS) involving in vitro diagnostic medical devices (IVDs).

In addition, information is provided on how to submit applications or notifications to the Health Products Regulatory Authority.

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.

This guide is intended for sponsors of PS (e.g. manufacturers, academic groups, clinical research organisations) who are interested in conducting PS involving IVDs in Ireland and may also prove helpful to ethics committees and other stakeholders.

The IVDR describes the operation of an electronic database supporting a number of functions related to the regulation of IVDs in Europe (known as 'EUDAMED'). Currently, the PS modules of EUDAMED do not work, and this guide details the contingency measures that the HPRA will employ pending the deployment of those modules.

Click this LINK to know more about the types of performance studies, the review process involved etc.


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