In December 2022, the Medical Device Coordination Group published various templates on performance study application and PMPF (Post Market Performance Follow-up) study notification.
Documents for performance study
When performing a study, the sponsor of the study should submit a notification or application to the Member state where conducting the study. In addition to the notification or application, the sponsor should also provide the documentation referred to in Chapter I of Annex XIV of Regulation on in vitro diagnostic medical devices (IVDR).
According to article 69 of the IVDR, the submission of the notification or application occurs electronically. As EUDAMED is not yet fully functional, other documents support the study procedures. Among others, there is an application/notification form. Specifically, this form includes the same data fields as they would appear on EUDAMED.
The MDCG publication provides templates to facilitate the procedure for competent authorities and sponsors. However, there might be additional national requirements to be necessarily taken into account.
These templates will not be in use anymore once EUDAMED is full functional.
In this MDCG document, you can find the following templates:
- Performance study – application/notification form under IVDR
- Additional performance device(s), comparator device(s), and site(s)
- Performance study supporting documents – Appendix of documents to attach
- Checklist of general safety and performance requirements, standards, common specifications and scientific opinions
Check out all relevant documents in our Library of Documents.