News Category: Regulatory news
The HPRA is seeking input from heath institutions and medical laboratories who manufacture and use in-house in vitro diagnostic medical devices (IVDs) in Ireland on our draft guide on in-house devices. The guide aims to assist health institutions and medical laboratories that manufacture and use in-house IVDs to understand and implement the requirements of the IVDR.
We are inviting comments on this draft guide from health institutions and medical laboratories in Ireland. This consultation is being made available on the HPRA website and replies are welcome from all stakeholders.
Start date of consultation: 13 December 2023
Closing date of consultation: 26 January 2024
The consultation is available to view on our Consultations webpage and replies are welcome from all stakeholders.
Please send any comments or questions on this consultation to devicesconsultation@hpra.ie.
Response documents will be published providing a general overview of the comments received and the changes made to the proposals as a result.
This consultation complies with government policy on public consultation, as described in the document ‘Consultation Principles and Guidance’.