IVDR Performance Evaluation: Scientific Validity, Analytical and Clinical Performance, and the Report

Its result is the clinical evidence for the device.

The work produces a performance evaluation plan with 13 minimum items and a performance evaluation report in the technical documentation. The report is updated at least annually for class C and D devices (IVDR Article 56(6)) and, as MDCG 2022-2 explains, as defined in the post-market surveillance plan for class A and B devices.

This page covers the three pillars, the plan, the report, the notified-body review with the class D checks, the MDCG guidance as of 6 November 2026 and the pending revision.

What Is IVDR Performance Evaluation?

Under IVDR Article 2(44), performance evaluation is an assessment and analysis of data to establish or verify the scientific validity, the analytical and, where applicable, the clinical performance of a device. Its output is clinical evidence: "clinical data and performance evaluation results, pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s)" (IVDR Article 2(36)). The clinical benefit is the positive impact of the device related to its function, such as diagnosis or monitoring, or on patient management or public health (IVDR Article 2(37)). Of the two EU MDR and IVDR regulations, Regulation (EU) 2017/746 is the one that governs performance evaluation.

The performance of a device, under IVDR Article 2(39), is its ability to achieve the intended purpose claimed by the manufacturer, and it consists of the analytical and, where applicable, the clinical performance. The IVDR has been in force since 25 May 2017 (IVDR Article 113(1)) and has applied since 26 May 2022 (IVDR Article 113(2)), directly applicable in every member state.

The Legal Basis: IVDR Article 56 and Annex XIII Part A

IVDR Article 56 sets the duty and Annex XIII Part A sets the method: Section 1.1 the plan, Sections 1.2.1 to 1.2.3 the three pillars, Section 1.3 the report. Both texts are in the consolidated IVDR on EUR-Lex.

Under IVDR Article 56(1), the manufacturer specifies and justifies the level of clinical evidence that is appropriate to the characteristics and the intended purpose of the device. Annex XIII Part B covers post-market performance follow-up and has its own detailed page below; both are part of the IVDR (Regulation (EU) 2017/746).

Which Devices Need a Performance Evaluation?

Every IVD of classes A, B, C and D needs a performance evaluation, including post-market performance follow-up, under IVDR Article 10(3) and Article 56. The depth follows the level of clinical evidence the manufacturer justifies for the device. The class decides two things described further down: how often the report is updated and who reviews it.

The Three Pillars: Scientific Validity, Analytical and Clinical Performance

IVDR Article 56(3) builds clinical evidence on three pillars: scientific validity, analytical performance and clinical performance, each with its own definition, sources and report. The table below sets the three pillars side by side with their article references.

Scientific Validity of the Analyte

Scientific validity is the association of an analyte with a clinical condition or a physiological state (IVDR Article 2(38)).

Annex XIII Part A Section 1.2.1 names the sources for scientific validity: devices measuring the same analyte or marker, peer-reviewed literature, consensus expert opinions of professional associations, proof of concept studies and clinical performance studies. The findings go into the scientific validity report, the first component of the performance evaluation report.

Analytical Performance and Its Parameters

Analytical performance is the ability of a device to correctly detect or measure a particular analyte (IVDR Article 2(40)), and Annex XIII Part A Section 1.2.2 requires it to be shown, as a general rule, by analytical performance studies. For novel markers without comparative methods, the manufacturer uses a composite reference standard or other well-documented methods; where neither exists, a clinical performance study against current clinical standard practice is required.

IVDR Annex I Section 9.1(a) names the analytical performance characteristics: analytical sensitivity, analytical specificity, trueness (bias), precision (repeatability and reproducibility), accuracy, limits of detection and quantitation, measuring range, linearity, cut-off, specimen collection and handling, interference and cross-reactions. Section 9.1(a) is one of the general safety and performance requirements of Annex I.

Clinical Performance and Its Data Sources

Clinical performance is the ability of a device to yield results that are correlated with a particular clinical condition or a physiological or pathological process or state in accordance with the target population and intended user (IVDR Article 2(41)). IVDR Annex I Section 9.1(b) names the clinical performance characteristics: diagnostic sensitivity, diagnostic specificity, positive predictive value, negative predictive value, likelihood ratio, and expected values in normal and affected populations.

Annex XIII Part A Section 1.2.3 names the sources of clinical performance data: clinical performance studies, peer-reviewed literature and published experience gained by routine diagnostic testing. IVDR Article 56(4) makes studies the default: clinical performance studies are carried out unless it is duly justified to rely on other sources of clinical performance data.

Performance Evaluation in Detail: Studies and Follow-Up

Two detailed pages cover what this overview summarises: how performance studies under IVDR Articles 57 to 77 are applied for, notified and run, and how post-market performance follow-up keeps the performance evaluation up to date. The table lists each page with the question it answers and its legal hook.

The Performance Evaluation Plan under the IVDR

The performance evaluation plan is the document in which the manufacturer specifies, under IVDR Article 56(2) and Annex XIII Part A Section 1.1, the characteristics and performance of the device and the process and criteria used to generate the evidence. The plan comes first, and the performance evaluation report later records what the plan produced.

The 13 Minimum Content Items of the Plan

Annex XIII Part A Section 1.1 lists 13 minimum items for the plan, from the intended purpose to the planning of post-market performance follow-up. The table gives each item as a short paraphrase in the order of the annex.

Item 13 links the plan to the follow-up described on the PMPF page listed above.

The Literature Search and the State of the Art

MDCG 2022-2 Section 6.4 explains that the literature search protocol forms part of the performance evaluation plan rather than a separate deliverable. The state of the art is item 9 of the plan in the table above, so it is set out in the same document as the literature search protocol.

The Performance Evaluation Report under the IVDR

The performance evaluation report collects the results of the plan and, under IVDR Annex XIII Part A Section 1.3.2, consists of three component reports and an assessment of those reports.

The Three Component Reports and Their Assessment

Each pillar ends in its own component report: the scientific validity report, the analytical performance report and the clinical performance report. The fourth part of the performance evaluation report is an assessment of those three reports. For the review of a finished report, MDCG 2022-2 Section 6.8 gives 18 questions and presents the list as non-exhaustive.

Where the Report Is Filed and What It Must Show

The performance evaluation report is part of the technical documentation under IVDR Annex II Section 6.2. It is kept with the technical documentation of Annex II, so each update described below changes that file as well.

The report includes both favourable and unfavourable data (IVDR Article 56(5); Annex XIII Part A Section 1.3.3).

How Often the Report Is Updated

For class C and D devices the performance evaluation report is updated when necessary, but at least annually (IVDR Article 56(6)); for class A and B devices MDCG 2022-2 Appendix II explains a continuous update, as necessary and as defined in the post-market surveillance plan. The table compares the two update cycles.

Classes are assigned under the seven IVDR classification rules of Annex VIII.

Class C and D devices, other than devices for performance studies, also carry a summary of safety and performance under IVDR Article 29, which includes a summary of the performance evaluation and of post-market performance follow-up; under IVDR Article 56(6) it is updated as soon as possible where necessary.

Who Reviews the Evidence and What They Check

A notified body reviews the clinical evidence and the performance evaluation of class B, C and D devices, which need its involvement under IVDR Article 48(3) to (9), and records its conclusions in a performance evaluation assessment report under IVDR Annex IX Section 4; non-sterile class A devices are self-declared under IVDR Article 48(10), and for sterile class A devices the notified body's involvement is limited to the sterile aspects.

Under IVDR Annex IX Sections 4.6 and 4.7, the notified body also reviews the need for and the adequacy of the plan for post-market performance follow-up, and it may define milestones. The bodies themselves are listed under notified bodies for the MDR and IVDR.

Extra Checks for the Highest-Risk Devices

Class D devices face up to three further requirements on their performance evaluation, each with its own detailed page. The three are listed below.

• EU reference laboratory verification: where an EU reference laboratory is designated, the notified body asks it to verify the claimed performance and compliance with the applicable common specifications (IVDR Article 48(5)); the laboratory gives a scientific opinion within 60 days, and with an unfavourable opinion the notified body does not deliver the certificate (IVDR Annex IX Section 4.9). See EU reference laboratories for class D IVDs.
• Expert panel consultation: where no common specifications exist and the type of device is certified for the first time, the notified body consults an expert panel and transmits the performance evaluation report within 5 days (IVDR Article 48(6)); see class D performance evaluation consultation.
• Common specifications: Commission Implementing Regulation (EU) 2022/1107 (OJ L 178, 5.7.2022, p. 3) lays down common specifications for certain class D devices on IVDR Annex I Sections 9.1(a) and (b), 9.3 and 9.4(a), which have applied since 25 July 2024; see common specifications under IVDR Article 9.

MDCG 2022-2: General Principles of IVD Clinical Evidence

MDCG 2022-2, the Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs), published by the MDCG in January 2022, is listed in the IVD section of the Commission's MDCG guidance list as of 6 November 2026. It is the source of the plan, review, update and legacy-data positions cited on this page.

The MDCG acts under IVDR Articles 98 and 99, and its guidance is not legally binding; notified bodies take it into consideration under IVDR Annex VII Section 1.6.2. Every document of the group is listed in the MDCG guidance register.

Orphan IVDs and the 12,000 Threshold

MDCG 2026-6, Clinical evidence for orphan in vitro diagnostic medical devices (MDCG, November 2026, announced by the Commission on 3 November 2026), explains that an IVD can be treated as orphan where the condition affects not more than 12,000 individuals in the European Union per year and a second criterion is met. The second criterion, in Section 4.1 of MDCG 2026-6, is either insufficient available alternatives or an expected clinical benefit compared with the alternatives or the state of the art. The same section states that orphan status confers no market exclusivity.

What the 2025 Proposal Would Change

The Commission's targeted revision of the MDR and IVDR would rewrite the performance evaluation article, but as of 6 November 2026 it is a proposal and every rule on this page applies unchanged. Its status is pending: Commission proposal COM(2025) 1023 of 16 December 2025 (procedure 2025/0404(COD)), at the stage "Awaiting committee decision" in the European Parliament's SANT committee as of 6 November 2026; not law. The past events on the Parliament's procedure file include the SANT draft report of 30 June 2026.

The proposal would replace the three component reports with one report in dedicated sections, drop the fixed annual update, and give class C and D manufacturers early expert panel advice on their clinical performance strategy. It would delete the EU reference laboratory verification paragraph and the class D expert panel consultation, and admit clinical performance data from devices for which equivalence can be demonstrated and from post-market surveillance, in particular post-market performance follow-up. The full proposal is tracked under MDR and IVDR amendments.

Common Questions on IVD Evidence

Three questions on IVD evidence are answered below: the use of older studies, the devices that rarely need new clinical data, and the process for medical devices other than IVDs. Each answer names its source.

Can Studies from before 2022 Still Be Used?

MDCG 2022-2 Section 6.7 explains that clinical performance studies conducted under the IVDD should be considered other sources of clinical performance data under IVDR Article 56(4). They therefore count as data for the clinical performance pillar, and relying on them still needs the due justification that Article 56(4) asks for.

Which Devices Rarely Need New Clinical Data?

MDCG 2022-2 Section 6.6 gives non-sterile specimen receptacles, microscopy glass slides and some general reagents as examples where clinical performance studies are not expected, with a justification in the performance evaluation.

Which Process Do Non-IVD Devices Follow?

Medical devices other than IVDs follow clinical evaluation under MDR Article 61 and Annex XIV, while IVDs follow performance evaluation under IVDR Article 56 and Annex XIII. For a device under the MDR, the device-side process is set out under clinical evaluation under the MDR.