IVD analytical and clinical performance requirements under RDC 848/2024

1. Key takeaways

IVDs in Brazil must demonstrate both analytical performance and clinical performance. Art. 81 of RDC 848/2024 writes the 2 requirements side by side into a single article, and neither can be missing. The resolution applies from 180 days after publication (Art. 88), ANVISA issued the effective-date notice on September 10, 2024, and the ESPR runs in parallel with the dedicated IVD regime RDC 830/2023, effective June 1, 2024. The practical reading is that every claim a manufacturer writes on the label must trace back to performance data covering the exact intended use and use environment claimed, and a claim without matching evidence is not a marketing weakness but a deficiency that will be issued at review.

2. Legal basis

• Essential Safety and Performance Requirements — RDC No. 848/2024, published in the DOU on March 8, 2024, Art. 81 (including §§1 through 4), Arts. 85 and 88
• In Vitro Diagnostic Medical Devices — RDC No. 830/2023, published on December 11, 2023 (DOU 234), effective June 1, 2024 (Art. 71), Arts. 12, 67 and 68
• Optimized Review Procedures — IN No. 290/2024, issued on April 4, 2024, effective June 3, 2024, Arts. 2, 3 and 4

3. Expert insights

The body of Art. 81 requires an IVD to achieve the analytical performance and the clinical performance claimed by the manufacturer and suitable for the intended use or purpose of use, taking into account the target patient population, the intended users and the use environment. §2 decomposes analytical performance into six classes: traceability of calibrators and control materials; measuring accuracy (trueness and precision); analytical sensitivity or limit of detection; analytical specificity; measuring interval or range; and sample stability. §3 anchors clinical performance in clinical or diagnostic sensitivity, clinical or diagnostic specificity, positive predictive value, negative predictive value, likelihood ratios, and the expected values in normal and diseased populations.

GRZAN’s judgment is that the most underestimated word in Art. 81 is the use environment. The same reagent cannot carry one performance claim across a central laboratory, an emergency unit, an ambulance and patient self-testing; analytical and clinical performance must each correspond to the claimed scenario. The common corporate practice of covering all claimed scenarios with one set of central-laboratory data will trigger a deficiency in Brazil directly, and the correction cycle consumes far more time than running scenario-specific verification in the first place.

The second pitfall is the coupling between the two evidence sets. Analytical performance answers whether the system measures accurately; clinical performance answers whether the measurement discriminates correctly. Neither substitutes for the other. GRZAN recommends organizing evidence in the three-stage chain of analytical performance, clinical performance and claims, so that every single claim can be traced back to its corresponding data identifiers without manual reconstruction during review.

Third judgment: RDC 830/2023 gives IVDs their own transitional arrangements. Control materials without assigned values and DNA/RNA extraction products must complete compliance within 365 days of the effective date (Arts. 67 and 68), so the time pressure on exactly these products is explicit rather than assumed; the IVD marketing authorization is valid for 10 years (Art. 12), matching medical devices.

Fourth trade-off: first marketing authorization applications for Class III (high risk) and Class IV (highest risk) IVDs may use the optimized review procedure of IN 290/2024 (effective June 3, 2024), provided approval has been obtained from an equivalent foreign regulatory authority (EFRA / AREE), and devices approved through simplified procedures do not qualify. Assembling the foreign approval evidence in advance materially reduces review round-trips on the performance documentation, which is where most of the elapsed time is otherwise lost.

Fifth judgment: performance evidence must be managed in lockstep with label claims. Art. 81 demands the performance the manufacturer claims; every additional claim written on the label or in the instructions for use requires one more set of supporting data. GRZAN recommends fixing the claims list before the verification protocol: claims first, protocol second, at the lowest cost. Reversing the order — testing first and writing claims afterward — almost guarantees evidence gaps that surface only when a reviewer tries to match each claim to a data set, and by then the analytical work has already been paid for once. Sixth judgment: keep the two regimes visible in one project plan. RDC 848/2024 supplies the performance principles while RDC 830/2023 supplies the procedure, the dossier expectations and the transition clocks; running the project on either text alone leaves the other layer’s obligations unowned, and the gap usually appears first in the claims-to-evidence mapping at deficiency stage.

4. Practical recommendations

• Build the file against the six analytical performance classes of Art. 81 §2 item by item, marking method, verification status and data identifiers for each.
• Organize clinical performance across sensitivity, specificity, predictive values, likelihood ratios and expected values, stating population representativeness.
• Create a claims-to-performance-data mapping table so every claim traces back to concrete evidence.
• Fix the claims list before the performance verification protocol to avoid evidence gaps caused by testing first and writing claims later.
• For products involving calibrators and control materials, prepare traceability and value-assignment evidence in parallel.
• Where optimized review is intended, verify that EFRA approval evidence meets Art. 3 of IN 290/2024 and exclude devices approved through simplified procedures (Art. 4).

5. Verification checklist

• □ Are all six analytical performance classes covered with verification reports?
• □ Are the five clinical performance indicators complete?
• □ Are the target population, intended users and use environment stated in the file?
• □ Does a mapping table link claims to performance data?
• □ Has applicability of the RDC 830/2023 Arts. 67 and 68 transition deadlines been confirmed?
• □ Do the claims list and the performance verification plan correspond one to one?

Regulatory information verified as of October 29, 2026

GRZAN Regulatory Team

GRZAN prepares IVD performance documentation for Brazil — analytical and clinical performance evidence aligned with Art. 81 of RDC 848/2024 and dossier structure under RDC 830/2023 — together with claims mapping, traceability files and optimized review eligibility checks. For IVD dossier support in Brazil, contact GRZAN at info@grzanglobal.com.