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 – see MDCG 2022-19.
To add to these documents, a template for ‘Substantial modification of performance study under Regulation (EU) 2017/746’ is also provided.
Insofar as possible, the modification of the performance study form includes the same data fields as the EUDAMED system in development.
MDCG 2022-20 – Substantial modification of performance study under Regulation (EU) 2017/746 – December 2022