In-house IVDs
This page provides information and supports for manufacturers of in-house in vitro diagnostic medical devices (IVDs).
For information on how to meet the requirements of the IVDR for in-house IVDs please review our Guide for Health institutions Who Manufacture and Use In-house IVDs in Ireland linked below. This guide helps answer the following questions
- What is an in-house IVD?
- What requirements apply for in-house IVDs?
- How can health institutions meet the in-house requirements?
- Is IVDR Annex I available in checklist form?
For more insight into the requirements for health institutions who manufacture and use in-house IVDs in Ireland please also review our online webinar.
https://www.youtube.com/watch?v=YuzZKeSfU4E
This is relevant for those working in health institutions, in particular hospital labs and lab services.
In this webinar, we offer practical suggestions to help health institutions comply with requirements and we identify available resources and guidance.
Notification of activities for health institutions
- Who is this notification process for?
- What information will I need to complete this notification?
- Who within the health institution should submit the notification?
- and many more.