December 15, 2022
The European Commission’s Medical Device Coordination Group (MDCG) has published a guidance document MDCG 2022-20 - Substantial modification of performance study under the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 - December 2022. The document clarifies guidance for obtaining permission to conduct a substantial modification of a performance study in European Union Member States according to the IVDR.
The document includes a form, which is to be used by the sponsor of a performance study. 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 IVDR. The application/notification must be submitted via the EUDAMED database (Article 69 IVDR).
Additionally, the sponsor is also required to notify the aforementioned Member State(s) via EUDAMED, of 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.
Until EUDAMED is brought fully online, 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. The modification of the performance study form includes the same data fields as the future EUDAMED module for performance study notifications.
Emergo by UL will post updates to the guidance as they become available.
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