Compassionate use applications for medical devices

What is a Compassionate Use application?

Under the EU Medical Device Regulation (MDR) and In-vitro Diagnostic Regulation (IVDR), the HPRA can authorise, in exceptional circumstances, an application for the use of medical devices that are not CE marked, for use in a hospital setting, only when it is in the interest of public health or patient safety to do so.

An application is required from the clinician involved and from the manufacturer of the medical device.

When is this process used?

The compassionate use process which authorises the use of a non-CE marked medical device following review by the HPRA is only used in specific cases where conditions are met such as:

• The use of the device is considered to be in the best interests of an individual patient
• There are no, or a lack of, suitable alternatives
• The benefit of using the device outweighs the anticipated risks

What does the HPRA consider in its assessment?

The HPRA receives and assesses applications made for compassionate use of non-CE marked devices.

The HPRA will assess the application made by both the clinician and the manufacturer for the use of the device. The HPRA also assesses whether the device is:

• Approved and available for clinical use in other territories, for example approved in the US by FDA but is not yet available in Europe
• Undergoing clinical development/research in Europe or elsewhere and has not yet compiled the full set of data required to progress an application for market approval.

How to apply for a compassionate use authorisation

• The doctor or clinician involved in the care of the patient submits an application to the HPRA
• The doctor or clinician must document the clinical rationale to justify the use of the device. This should include information on whether there is a lack of suitable alternatives.
• The doctor or clinician must confirm that appropriate ethical and governance aspects have been addressed at institutional level.
• The manufacturer of the medical device must submit a manufacturer’s application to the HPRA.
• The manufacturer must provide information on any testing conducted on the device to date, including:
  • pre-clinical testing (assessing device safety and the physical and biological properties)
  • results of any early clinical testing in humans

Applications should be submitted to devices@hpra.ie. Following application assessment, if the HPRA is satisfied that the device meets the conditions required it may authorise the use of the specific device for the individual patient. If issued, the authorisation is subject to specific conditions including the need to report any serious adverse events which arise.

If you are a clinician and are considering submitting a compassionate use application or you have any other queries about the use of medical devices in Ireland, please contact devices@hpra.ie. We will provide you with the relevant application forms and can discuss the application with you.