Performance studies for in vitro diagnostic medical devices
This webpage provides you with information about performance studies (PSs) for in vitro diagnostic medical devices (IVDs).
On this page, we describe the various types of PSs, how to submit an application for a PS or modification to us, as well as how to report serious adverse events. We also provide information about the supports we offer to device developers.
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 performance studies which must be met from 26 May 2022.
For PSs conducted in Ireland you may need to:
- Submit an application for the PS.
- Make a notification for the PS.
- Follow other requirements such as adverse event reporting.
We developed a Guide to Performance Studies Carried out in Ireland. This guide should help anyone conducting a PS to identify and meet the requirements that apply to them. It provides useful information about the different types of PSs and how to submit an application or notification to us. This information may also be useful for ethics committees and other stakeholders.
How do I submit an application for, or a notification of, a performance study to the HPRA?
We have provided step by step instructions on how to submit an application for, or a notification 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 help determine whether an application or a notification is required.
Step 1: Submit the appropriate form
Step 2: Pay the relevant fees
- We have published a Guide to Fees for Human Products. This guide should assist applicants in identifying the correct category of fee to accompany submissions.
- This guide follows the order of the fees in our ‘Fee Application Form’. A fee application form should be completed and included with all submissions.
- We have also published Payment of Fee Instructions which provides additional details when paying fees by credit transfer or EFT.
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.
PSs that commence on or after 26 May 2022 will need to meet the applicable IVDR authorisation or notification requirements.
Performance study modification
Before a sponsor can make a substantial modification to a PS they must complete and submit an online application form to us. If you are unsure whether a modification is substantial or non-substantial, please contact us by email 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 such a time as EUDAMED is functional for reporting.
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 take into account the principles of this guidance. This document provides practical information about definitions, timelines, reporting methods and reportable events.
Requirements for performance studies initiated 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.
The new reporting requirements apply prospectively to SAE and device deficiencies that happen after 26 May 2022. Sponsors do not need to retrospectively 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 different supports to device developers depending on the stage of development of their device.
This is a cross departmental initiative in the HPRA to support any innovative medical product. Further information is available on the Innovation Office webpage
These are typically for early stage 'spin-out' or start-up organizations. The purpose of these meetings is to provide an introduction to the role of the HPRA and a broad overview of the regulatory requirements in the pre-market phase of medical device development.
These are typically for study sponsors who have prepared for a performance study in Ireland, and who may have some outstanding questions prior to the submission of their application to the HPRA.
All of the above services are free of charge. The HPRA encourage preliminary and pre-submission meetings with sponsors of performance studies. 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 the Medical Device Department at email@example.com.