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.

• For applications to conduct a PS, complete our application form. 
• To notify us of a PS for a companion diagnostic, complete our Article 58 notification form. 
• To notify us of a PS for a CE-marked IVD, complete our Article 70 notification form. 

Step 2: Pay the relevant fees.

• We have a Guide to Fees for Human Products to help you identify the correct fee for submissions.
• This guide follows the order of the fees in our ‘Fee Application Form’. Please complete and include a fee application form with all submissions.
• We also have Payment of Fee Instructions when paying fees by credit transfer or EFT. 

Step 3: Submit documentation and contact the HPRA.

• Submit your application or notification form with the required documents via the Common European Submission Portal (CESP). 
• If you have not used CESP before, their website provides general information, frequently asked questions and regular tutorials for study sponsors.
• Once your submission is complete, please let us know and provide us with your CESP reference number by email at devices@hpra.ie. 

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 devices@hpra.ie.

Serious adverse event and device deficiency reporting

Serious adverse events (SAE) and device deficiencies should be reported to us by email at devices@hpra.ie, 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.

Innovation office

This is a HPRA initiative to support innovative medical products. You can find more details on our Innovation Office webpage.

Preliminary meetings

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.

Pre-submission meetings

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 devices@hpra.ie.

Contact Us

If you have a query about performance studies in Ireland, please contact us at devices@hpra.ie.