Clinical investigations for medical devices

For information on how to conduct or modify a clinical investigation for medical devices in Ireland, please review our Guide to clinical investigations carried out in Ireland. This guide is for clinical investigation sponsors and addresses several key questions including:

• What is a clinical investigation?

• How do I conduct a clinical investigation in Ireland?

• How do I submit a clinical investigation application to the HPRA?

• Should I inform the HPRA of a modification to my clinical investigation?

• How do I report serious adverse events and device deficiencies? 

• How do I end a clinical investigation in Ireland?

• What supports does the HPRA offer to device developers?

• How do I request a preliminary or pre-submission meeting for a clinical investigation with the HPRA?

If you have a query not covered in this guide, please send your query to devices@hpra.ie.