EU: Substantial Modification of Performance Study Under Regulation (EU) 2017/746

A guideline paper titled MDCG 2022-20 - Substantial Modification of Performance Study under the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 - December 2022 has been released by the Medical Device Coordination Group (MDCG) of the European Commission. In accordance with the IVDR, the document explains instructions for requesting authorization to conduct a substantial modification of a performance study in European Union Member States.

The document comprises a form that the performance study sponsor must fill out which also can be found in the template for “Substantial adjustment of performance study under Regulation (EU) 2017/746”. The Member State(s) in which a performance study is to be performed must receive an application or notification from the performance study's sponsor, along with the supporting materials listed in Chapter I of Annex XIV IVDR. The EUDAMED database is where the application or notice must be sent (Article 69 IVDR).

The sponsor is also expected to inform the aforementioned Member State(s) via EUDAMED of any changes to a performance study that are likely to significantly affect the subjects' rights, safety, or health, or the robustness or accuracy of the data the performance research produces.

A number of performance study application/notification documents have been developed to support performance study procedures with regard to the IVDR until EUDAMED is fully operational (see MDCG 2022-19). The performance study notification form change incorporates the same data fields as the upcoming EUDAMED module.

Source: European Commision

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