In Vitro Diagnostic Medical Devices Regulation – In-house IVDs

On 15 January 2024, the HPRA presented at a webinar hosted by the National Clinical Pathology Programme on the topic of in-house in-vitro diagnostic medical devices (IVD’s).

The webinar provided insights into the requirements for health institutions who manufacture and use in-house IVDs in Ireland. This is relevant for those working in health institutions, in particular hospital laboratories and laboratory services.

The HPRA offered practical suggestions to assist health institutions in complying with these requirements and highlighted additional available resources and guidance.

You can view the recording of the webinar below. 

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If you wish to receive a copy of the presentation slides from the webinar you can request one by emailing devices@hpra.ie.