Article 58 and Annex XIV set out the application procedure for performance studies. Interventional clinical performance studies, studies involving invasive sample-taking done only for the purpose of the study, and studies of companion diagnostics using leftover samples with additional testing must be authorised by the competent authorities of the Member States in which the study is conducted. Applications are submitted through EUDAMED using a single identification number (SIN).

Why it matters

The IVDR harmonises the performance-study route across Member States, replacing the fragmented national procedures of the IVDD era. Timelines mirror MDR clinical investigations: 10 days for validation, then 45 days (extendable) for substantive review.

Common pitfalls

•Mistaking all performance studies as requiring a formal application: Only specific types of performance studies, such as interventional clinical performance studies or those involving invasive sample-taking, mandate prior authorization via a formal application.
•Underestimating the EUDAMED submission complexity: While EUDAMED offers a harmonized platform, navigating its requirements and ensuring complete, accurate submission for the Performance Study Application can be challenging for those unfamiliar with the system.
•Failing to account for varying Member State interpretations or extended review timelines: Although the IVDR aims for harmonization, national competent authorities may still have nuances in their review processes, and the 45-day review period can be extended, impacting study commencement dates.
•Overlooking the need for a Single Identification Number (SIN) for EUDAMED submissions: All applications for performance studies must be submitted through EUDAMED and require a unique SIN to track the study effectively across Member States.
•Assuming all companion diagnostic studies require an application: Only companion diagnostic studies using leftover samples with additional testing, beyond the routine diagnostic workup, are subject to this formal application requirement.

Sources

Regulation (EU) 2017/746, Articles 58 and 66 · EUR-Lex
MDCG 2022-19 Performance Study Application · MDCG
European Commission - Medical Devices · European Commission

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