In-house manufacturing by health institutions

This page provides information for health institutions conducting in house manufacturing activities for medical devices and IVDs. 

Medical devices and IVDs can be manufactured and used in-house within EU health institutions. This is allowed, on a non-industrial scale, only when:

• The device addresses the specific needs of target patient groups.
• An equivalent CE-marked device is not available on the market or does not meet the appropriate performance level.

These "in-house devices" are exempt from certain provisions of the MDR or IVDR. 

However, to ensure the highest level of patient protection, the health institution must adhere to specific requirements set out in Article 5(5) of the relevant Regulation.

Guidance on in-house manufacturing activities

Practical European guidance (i.e. MDCG 2023-1) has been published which covers the scope and conditions under which health institutions may conduct in house manufacturing activities. 

We have also published national guidance below which covers in house manufacturing activities for IVDs specifically. 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.

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 

Health institutions who manufacture and use in-house devices are asked to notify the HPRA of their activities. Our FAQ on notification for in-house manufacturers of medical devices and in vitro diagnostic medical devices provides answers to questions such as: 

• Who is this notification process for? 
• What information will I need to complete this notification? 
• Who within the health institution should submit the notification? 
  

Health institutions who manufacture ‘in house devices’ can notify the HPRA using our notification form.