Health institutions

Health institutions which manufacturer and use in-house medical devices or IVDs, must notify us of their organisation and device details. 

The definition of health institution and in-house device is provided below.

What is a health institution?

A health institution is an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health (definitions 29 and 36 of the IVDR and MDR, respectively). According to recitals 29 and 30 of the IVDR and MDR, health institutions include hospitals as well as institutions, such as laboratories and public health institutes that support the health care system and/or address patient needs, but which do not treat or care for patients directly. The concept of health institution does not cover establishments primarily claiming to pursue health interests or healthy lifestyles, such as gyms, spas, wellness and fitness centres. 

What is an in-house device?

In-house device means a device which:

• is manufactured and used only within a health institution,
• complies with all of the conditions in Article 5(5) of the Medical Devices Regulation, and
• is not manufactured on an industrial scale;

How do I notify the HPRA as a health institution manufacturing and using in-house devices?

You can notify us of your activities using our notification form.