Overview of medical device & IVD regulation for hospitals

This page is for hospitals and healthcare professionals.

It provides a general overview of how devices are regulated and the key considerations for hospitals.

What are medical devices and how are they regulated?

Medical devices are products, software or equipment intended for a medical purpose.

A medical purpose may include:

  • Diagnosis, prevention, monitoring, prediction, alleviation or treatment of disease or injury.
  • Investigation, replacement, or modification of anatomy or physiological processes.
  • Control or support of conception.
  • Cleaning, disinfection, or sterilisation of medical devices.

Unlike medicines, medical devices and IVDs do not achieve their medical purpose by pharmacological, immunological or metabolic means. In general, they act by physical means. 

Examples of medical devices include:

  • Wheelchairs
  • Blood pressure monitors
  • Thermometers
  • Pacemakers 

Medical devices are regulated under Regulation EU 2017/745 on Medical Devices (MDR). The MDR became fully applicable in 2021. 

What are IVDs and how are they regulated?

An IVD is a medical device which is a reagent, kit, instrument, software or system intended for a medical purpose. IVDs may be used to provide information about:

  • Physiological or pathological conditions.
  • Congenital impairments.
  • Disease predisposition.
  • Donor–recipient safety and compatibility.
  • Treatment response or adverse reactions.
  • Monitoring of therapeutic measures.

Lab instruments used to measure substances such as cholesterol, liver enzymes, and electrolytes in blood samples are also IVDs. Other examples of IVDs include:

  • Blood glucose test kits
  • Pregnancy tests
  • Tests for cancer biomarkers

IVDs are regulated under Regulation EU 2017/746 on In Vitro Diagnostic Medical Devices (IVDR). The IVDR became fully applicable in 2022. 

What are the key regulatory considerations for hospitals?

It is important for hospitals to understand the key aspects of device regulation. This includes:

  • Understand how to verify the compliance of devices.
  • Understand alternative routes for using devices, e.g. compassionate use applications, derogations, clinical research, custom made devices and in house manufacturing.
  • Understand safety reporting.
  • Understand how to manage corrective actions.

What is the role of the HPRA for medical devices and IVDs?

We are the National Competent Authority responsible for the application of the MDR and IVDR in Ireland. 

We monitor medical devices and IVDs on the Irish market to ensure they are safe and perform as intended. We do not play a role in the authorisation or approval of medical devices or IVDs.

For more information about our role, please review our webpage.