Does every performance study need regulatory authorisation before it starts?

No. Non-interventional studies using leftover samples with no additional invasive procedures may have lighter notification requirements, while interventional clinical performance studies and studies involving additional invasive sampling generally require Member State authorisation under Articles 58 to 77 before enrollment begins. The distinction hinges on invasiveness and whether results affect patient management in real time.

What sponsor obligations apply once a performance study is underway?

Sponsors must maintain ethics committee approval, obtain informed consent, monitor and report adverse events, and keep the study consistent with the protocol reviewed by the competent authority, mirroring the ongoing obligations under MDR clinical investigations. Substantial modifications to an authorised study must be reported and, in many cases, reauthorised before implementation.

What is a frequent mistake sponsors make with companion diagnostic performance studies?

Sponsors often underestimate the added complexity of aligning a companion diagnostic performance study with the corresponding drug development timeline, which can create a bottleneck if the study protocol is not designed jointly with the pharmaceutical partner from the outset. Article 2(42) study design should reflect both the IVD's intended purpose and the medicinal product's target population.

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Performance Study (IVDR)

A study to establish or confirm analytical or clinical performance of an IVD, governed by IVDR Articles 57 to 77.

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

Definition

Article 2(42) of the IVDR defines a performance study as a study undertaken to establish or confirm the analytical or clinical performance of a device. Articles 57 to 77 and Annex XIII Part A Section 2 set out study design, sponsor obligations, ethics review, informed consent, and adverse-event reporting, with additional obligations for interventional studies and studies involving companion diagnostics.

What the regulation says

Regulation (EU) 2017/746 (IVDR), adopted on 5 April 2017 and applicable from 26 May 2022, defines a performance study in Article 2(42) as a study undertaken to establish or confirm a device's analytical or clinical performance. Article 57 sets general requirements for scientific validity, ethical conduct and protection of subjects. Annex XIII, Part A, Section 2 addresses clinical performance studies, including their design, performance study plan and reporting. For MedTech sponsors, the applicable pathway depends on how specimens are collected, whether study results influence patient management and the risks to participants. Article 58 triggers additional requirements for studies involving surgically invasive sampling solely for the study, interventional clinical performance studies, or additional invasive procedures or other risks to subjects. These requirements cover ethics review, informed consent under Article 59, sponsor responsibilities and the application and authorisation procedures in Article 66. Article 76 governs recording and reporting of adverse events and relevant device deficiencies for studies within its scope. Under Article 58(2), companion diagnostic studies generally follow the same additional requirements, but studies using only leftover samples are exempt from that regime and must instead be notified to the competent authority.

What this means in practice

Performance studies are the IVDR analogue of MDR clinical investigations but with categories tied to invasiveness of sampling and use of results in patient management. Interventional studies (Article 58(2)) require prior authorisation by Member States, similar to MDR clinical investigations.

Examples

A laboratory studies an IVD assay's precision and detection capability using stored specimens, without returning results for patient care. The sponsor assesses the applicable IVDR requirements rather than assuming an interventional study pathway applies.
A prospective study uses an investigational IVD result to determine whether participants receive a particular treatment. Because results influence patient management, the sponsor follows the interventional clinical performance study pathway, including prior authorisation.
A study evaluates whether a proposed companion diagnostic identifies patients with a tumour biomarker relevant to a corresponding medicine. Its plan addresses clinical performance endpoints and the IVDR requirements specific to companion diagnostic studies.

Common pitfalls

•Assuming every performance study follows the same authorisation pathway. Requirements depend on features such as invasive sampling, additional procedures, and use of results in patient management.
•Treating analytical performance alone as proof of clinical performance. Demonstrating reliable measurement does not necessarily establish how results relate to a clinical condition in the intended population.
•Treating MDR clinical investigation requirements or FDA clinical trial information as substitutes for IVDR requirements. An IVD performance study needs an assessment against the applicable IVDR provisions.

Frequently asked questions

Both are pre-market human studies, but a performance study under Article 2(42) of Regulation (EU) 2017/746 is categorised by the invasiveness of sample collection and whether results are used in patient management, rather than by device implantability as under the MDR. Interventional performance studies under Article 58(2), where results influence treatment decisions, require prior Member State authorisation similar to MDR clinical investigations.

Grouped by theme

Editor's picks

· Hand-selected related concepts

Clinical & Trials

Clinical Investigation Plan(CIP)

EU MDR's term for the protocol document governing a clinical investigation of a device.

Regulatory

Clinical Performance (IVDR)

The ability of an IVD to yield results correlated with a clinical condition in the target population and intended user.

Regulatory

EU In Vitro Diagnostic Regulation(IVDR)

Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.

More in Clinical & Trials

· Same category

Clinical & Trials

Adaptive Trial Design

Trial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data.

Clinical & Trials

Adverse Event(AE)

Any untoward medical occurrence in a subject, whether or not related to the device.

Clinical & Trials

ALCOA+

Data integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate (plus Complete, Consistent, Enduring, Available).

Clinical & Trials

Analytical Sensitivity

An IVD's ability to detect small quantities of an analyte.

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A study to establish or confirm analytical or clinical performance of an IVD, governed by IVDR Articles 57 to 77.

·Performance studies are the IVDR analogue of MDR clinical investigations but with categories tied to invasiveness of sampling and use of results in patient management.
·Interventional studies (Article 58(2)) require prior authorisation by Member States, similar to MDR clinical investigations.

Remember this

Watch out: Assuming every performance study follows the same authorisation pathway. Requirements depend on features such as invasive sampling, additional procedures, and use of results in patient management.

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