Performance studies for in vitro diagnostic medical devices
This page provides information about performance studies (PSs) for in vitro diagnostic medical devices (IVDs).
It describes the various types of PSs, how to submit an application for a PS or modification to us, and how to report serious adverse events.
What is a performance study?
A PS is a study that establishes or confirms the analytical or clinical performance of a device. The In Vitro Diagnostic Medical Devices Regulation (IVDR) outlines specific requirements for PSs.
For PSs conducted in Ireland you may need to:
- Apply for a PS.
- Notify us of a PS.
- Follow other requirements such as adverse event reporting.
Where can I find guidance on performance studies?
We have a Guide to Performance Studies Carried out in Ireland. This guide will help anyone conducting a PS to identify and meet applicable requirements.
It provides information about the different types of PSs and how to make a PS application or notification. This may also be useful for ethics committees and other stakeholders.
How do I apply for, or notify of, a performance study to the HPRA?
We provide step by step instructions on how to apply for, or a notify of a PS to us below. These instructions are only applicable to PSs conducted in Ireland.
Please refer to our Guide to Performance Studies Carried out in Ireland to determine whether an application or a notification is required.
Step 1: Submit the appropriate form.
Step 2: Pay the relevant fees.
Step 3: Submit documentation and contact the HPRA.
The IVDR provides for a central European electronic system for PS applications (i.e., the EUDAMED system). This system is subject to delay. In the interim, you can make applications via CESP. In the absence of EUDAMED, coordinated applications and assessments across member states are not possible.
Performance study modification
Before a sponsor can make a substantial modification to a PS, they must submit an online application to us. If you are unsure whether a modification is substantial or non-substantial, please email us at firstname.lastname@example.org.
Serious adverse event and device deficiency reporting
Serious adverse events (SAE) and device deficiencies should be reported to us by email at email@example.com, until EUDAMED is functional.
The MDCG have published guidance on the reporting of serious adverse events and device deficiency in clinical investigations under the MDR. In the absence of IVDR specific guidance, sponsors should consider the principles of this guidance. This document provides information about definitions, timelines, reporting methods and reportable events.
Requirements for performance studies started before 26 May 2022
IVDR requirements relating to authorisation or notification do not apply to PSs approved or started before 26 May 2022.
These studies may continue after this date, however, sponsors must report SAE’s and device deficiencies to us in line with IVDR requirements before and after 26 May 2022.
Sponsors do not need to verify if adverse events have occurred before this date.
Research ethics committees
PSs in Ireland requiring an application for authorisation need an ethics opinion from the National Office for Research Ethics Committees (NREC). Sponsors do not need to make an application and ethics opinion submission at the same time. However, the study cannot start until both are complete. You can find more information on NREC’s website.
What support do we offer?
We offer three supports to device developers depending on the stage of their device.
This is a HPRA initiative to support innovative medical products. You can find more details on our Innovation Office webpage.
These are typically for early stage 'spin-out' or start-up companies. These meetings introduce our role and give an overview of the regulatory requirements in the pre-market phase of device development.
These are typically for study sponsors preparing for a performance study in Ireland, and who may have outstanding questions prior to the submission of their application to us.
Each support is free of charge. we encourage preliminary and pre-submission meetings with sponsors. To apply for a pre-submission meeting, please complete this form and send it to firstname.lastname@example.org.
If you have a query about performance studies in Ireland, please contact us at email@example.com.