How is the performance study application actually submitted?

Applications are submitted through EUDAMED using a single identification number (SIN), which harmonises the submission process across Member States and replaces the fragmented national procedures that existed under the IVDD. This is a significant procedural change for sponsors used to country-by-country paper submissions.

What are the typical review timelines once an application is submitted?

The process mirrors MDR clinical investigation timelines: Article 66 sets out roughly 10 days for validation of the application, followed by a substantive review period of about 45 days that can be extended, particularly for higher-risk or novel study designs. Sponsors should plan enrollment start dates around these review windows rather than the submission date.

What happens if a sponsor wants to change the study protocol after authorisation?

Article 70 governs substantial modifications to an authorised performance study, requiring the sponsor to notify and, in many cases, obtain reauthorisation from the relevant competent authorities before implementing the change. Implementing a substantial modification without following this process can jeopardize the validity of the study's regulatory authorisation.

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Performance Study Application (IVDR)

Formal submission via EUDAMED required before commencing certain performance studies under IVDR Annex XIII and XIV.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed July 25, 2026

Definition

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).

What the regulation says

Article 66 defines the substantive assessment procedure and timelines; Article 70 governs substantial modifications to authorised studies.

What this means in practice

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.

Examples

A manufacturer developing a novel in vitro diagnostic test for a rare genetic condition plans an interventional clinical performance study to assess its diagnostic accuracy against a comparator method, requiring a Performance Study Application.
A company designing an IVD for early cancer detection needs to conduct a performance study involving prospective collection of patient blood samples solely for research purposes, necessitating submission of an application to the relevant competent authorities.
A MedTech firm has developed a new companion diagnostic for a targeted therapy. To validate its performance, they will use leftover patient tissue samples from a previous clinical trial but will perform additional, specific tests for the companion diagnostic, triggering the need for a Performance Study Application.

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.

Frequently asked questions

No. Authorisation under Article 58 and Annex XIV is required specifically for interventional clinical performance studies, studies involving invasive sample-taking performed solely for study purposes, and certain companion diagnostic studies using leftover samples with additional testing. Purely observational studies using existing samples without additional invasive procedures may fall outside this authorisation requirement.

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Formal submission via EUDAMED required before commencing certain performance studies under IVDR Annex XIII and XIV.

·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.
·Applications are submitted through EUDAMED using a single identification number (SIN).

Remember this

Watch out: 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.

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