MDCG published performance study application/ notification documents under IVDR
9 January 2023
The sponsor of a performance study is required to submit an application/notification to the Member State(s) in which a performance study is to be conducted, accompanied by the documentation referred to in Chapter I of Annex XIV of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR). The application/notification must be submitted by means of the electronic system referred to in Article 69 of the IVDR.
Additionally, the sponsor of a performance study is required to notify the Member State(s) in which a performance study is being or is to be conducted if it intends to introduce modifications to a performance study that are likely to have a substantial impact on the safety, health or rights of the subjects or on the robustness or reliability of the data generated by the performance study by means of the same electronic system.
In the absence of the European database on medical devices (EUDAMED), a series of performance study application/notification documents have been created to support performance study procedures with respect to the IVDR.
These documents include:
- Performance study – application/notification form under the IVDR
- Addendum to the performance study application/notification form for:
- Performance study supporting documents – Appendix of documents to attach
- Checklist of general safety and performance requirements, standards, common specifications and scientific opinions
Insofar as possible, the performance study application/notification form includes the same data fields as the EUDAMED system in development.
To add to these documents, a template for ‘Substantial modification of performance study under Regulation (EU) 2017/746’ is also provided.
For further guidance with respect to the application of certain IVDR provisions in the absence of EUDAMED please see MDCG 2022-12. In the absence of EUDAMED, the Union-wide unique single identification number for a performance study, to be used for all relevant communication in relation to that performance study, will be the CIV-ID which can be generated in Eudamed, the electronic system which supports the medical device Directives.
The documents are intended to be facilitative and their use by the competent authorities and sponsors is encouraged, however it is important to check with the individual Member State in which the performance study is planned to be conducted for any specific national requirements. It is planned that these templates will be withdrawn once the EUDAMED module for performance studies is fully functional.