EU IVDR Performance Studies under Article 57: General Requirements and GSPR Boundaries

1. Key takeaways

A performance study, defined in Article 2(42) as a study undertaken to establish or confirm the analytical or clinical performance of a device, is subject to the general requirements of Article 57. Under Article 57(1), the manufacturer must ensure that devices used in a performance study conform to the general safety and performance requirements (GSPR) of Annex I, except for those aspects covered by the scope of the study, and that all precautions have been taken with regard to those aspects to protect the health and safety of patients, users and other persons. Under Article 57(3), the design and conduct of the study must ensure that the rights, safety, dignity and well-being of subjects are protected and prevail over all other interests, and that the data generated are scientifically valid, reliable and robust.

These provisions set the baseline for every performance study regardless of its design or setting, and the more specific obligations of the following chapters are built on top of them. Understanding where the baseline ends and where the additional requirements begin is the first analytical task of any study sponsor.

2. Legal basis

3. Expert insights

Insight 1: The GSPR exemption for aspects covered by the scope of the study has boundaries.

The exemption in Article 57(1) applies only to the aspects that the study itself is examining, for instance a clinical performance that has not yet been established, and even for those aspects all precautions must be taken to protect patients, users and other persons. All other GSPR, such as analytical performance, stability, labelling and risk control measures, remain fully applicable. Treating the whole device as if it were exempt is the most common misconception in the performance study phase: assessors and ethics committees expect to see a clear table showing which aspects fall inside the study scope and which GSPR continue to apply, together with the precautions taken for the exempted aspects. Without that boundary document, the study protocol looks non-compliant even when it is not.

Insight 2: Devices used in performance studies do not follow the ordinary conformity assessment routes.

Article 48(11) provides that devices used in performance studies are governed by Articles 57 to 77, rather than by the conformity assessment routes of Annexes IX, X and XI under Article 48. This means a device may be used in a performance study without bearing the CE marking, provided the study follows the application procedure of Article 66 and the assessment by the Member States under Article 67. The practical consequence is a different project shape: instead of preparing a certification dossier, the sponsor prepares a study application, including the investigator brochure and the documents required by Article 66, and plans for the timeline of national assessments. Teams that only know the certification path routinely misestimate the study route, which is why the distinction should be settled before the project plan is written.

Insight 3: Studies using left-over samples are also subject to data protection law.

The second subparagraph of Article 57(3) states explicitly that a performance study, including a study using left-over samples, must be conducted in accordance with applicable data protection law. In multi-centre and cross-border studies this directly engages the GDPR and the supplementary rules adopted at Member State level, covering lawful bases for processing, anonymisation or pseudonymisation choices, and the conditions under which residual samples may be used. Sponsors should build a data protection file chain for studies involving human samples, covering the sample origin, the consent or waiver basis, and the documentation of the processing arrangements at each site, because the mere fact that samples are left-over does not lift the obligations.

Insight 4: Article 57(2) pulls the study conditions back to real-world use.

Article 57(2) requires that a performance study be conducted, where appropriate, in circumstances similar to the normal conditions of use of the device. This provision shapes the design of the study protocol: the selection of sample sources, the types of operators performing the testing and the environmental conditions under which the device runs should reflect how the device will actually be used. It is also the provision reviewers invoke when challenging study conclusions reached only under ideal laboratory conditions. A protocol that documents why its conditions do or do not mirror normal use, and what the consequences of that choice are for the interpretation of results, is materially more defensible than one that ignores the question.

4. Practical recommendations

1. Begin the study protocol with a boundary table for the GSPR exemption: list the aspects examined by the study, which may be exempted, and the remaining GSPR that still apply, together with the precautions taken under Article 57(1).
2. Design the study conditions close to real-world use in line with Article 57(2), and document the reasoning for the chosen sample sources, operator types and environmental conditions.
3. For studies involving human samples, establish a data protection compliance file chain under Article 57(3), including left-over sample documentation and site-level processing arrangements.
4. Plan the application and Member State assessment timelines under Articles 66 and 67 early, and incorporate the substantial modification procedure of Article 71 into the study change management.
5. For studies using left-over samples, assess separately whether the additional requirements of Article 58 apply to the specific design.

5. Verification checklist

• □ A GSPR exemption boundary table has been prepared under Article 57(1)
• □ The study condition design has been benchmarked against real-world use under Article 57(2)
• □ A mechanism ensuring that the rights, safety, dignity and well-being of subjects prevail has been established under Article 57(3)
• □ Data protection documentation, including for left-over samples, is complete under Article 57(3)
• □ The application and assessment timelines of Articles 66 and 67 are included in the project plan
• □ The substantial modification procedure of Article 71 has been incorporated into change management

GRZAN supports manufacturers entering or operating in the EU in vitro diagnostic market with performance study compliance under the IVDR: GSPR exemption boundary tables, protocol design against Article 57(2), data protection file chains for human samples, application preparation under Articles 66 and 67, and substantial modification management under Article 71. Contact us at info@grzanglobal.com to structure your performance study programme.

Legal information verified as of 29 October 2026.