In-house manufacturing of in vitro diagnostic medical devices – stakeholder survey

News Category: Regulatory news

Date: 22/11/2021

We have published a survey to collect information about how in-house manufacturing of in vitro diagnostic medical devices will be impacted by the In Vitro Diagnostics Regulation (IVDR). We invite medical laboratory scientists and personnel who work with in vitro diagnostic medical devices to complete the survey, which is available at this link: HPRA IVD In-house Manufacturing Survey.

This survey is a follow-up to a preliminary survey conducted by the HPRA in 2020 to gather information on devices manufactured, modified and used only within health institutions, known as ‘in-house devices’. The information collected will be used to assist in the implementation of IVDR.

We would appreciate your feedback in relation to how the IVDR will impact in-house manufacturing and any concerns you may have. The survey will remain open until Friday, 17 December 2021. Please assist us by forwarding this survey to relevant individuals and laboratories, including contract testing laboratories. 

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