Clinical evaluation and mandatory clinical investigations under RDC 848/2024

1. Key takeaways

Arts. 15 through 19 of RDC 848/2024 rewrite clinical evaluation from an optional supporting document into a hard requirement, and Art. 19 identifies the Class 2 situations in which a clinical investigation report on the device itself must be submitted. The resolution enters into force 180 days after publication (Art. 88), and ANVISA issued the effective-date notice on September 10, 2024. GRZAN’s judgment is that the real threshold is not the volume of documentation but the innovation determination: whether a device counts as innovative, regardless of its risk class, decides whether evidence from the device itself is mandatory, and that single question causes more rejections at low risk classes than any formatting issue ever will.

2. Legal basis

• Essential Safety and Performance Requirements — RDC No. 848/2024, published in the DOU on March 8, 2024, Arts. 15, 16 (items I and II and §§1–3), 17, 18, 19 and 88
• Classification, Notification and Registration of Medical Devices, and Labeling and Instructions for Use Requirements — RDC No. 751/2022, decided on September 15, 2022, Arts. 7, 10, 11, 57 and 58
• In Vitro Diagnostic Medical Devices — RDC No. 830/2023, published on December 11, 2023 (DOU 234), effective June 1, 2024 (Art. 71), Art. 12

3. Expert insights

Art. 16 offers two evidence routes: a clinical evaluation report containing a critical appraisal of the scientific literature, whose evidence levels must match the hierarchy used in evidence-based medicine; or a clinical investigation report, which for IVDs corresponds to a clinical performance study report. Art. 17 requires clinical investigations to follow good clinical practice, and investigations conducted in Brazil must additionally comply with ANVISA’s specific provisions. Art. 18 is the threshold switch: where existing data are insufficient to address the benefit-risk profile, the claims and the adverse events, a clinical investigation becomes mandatory. Art. 19 then locks in the Class 2 situations — devices containing innovations in design, raw materials or intended indications (regardless of risk classification), and Class III and IV devices whose performance is so tightly bound to materials, design and manufacturing processes that validation with the device’s own clinical data is required.

GRZAN’s judgment is that the words regardless of risk classification are the single largest difference between Brazil and most other markets. Class I and Class II devices follow the notification route with no technical review, so companies tend to assume that low risk equals no clinical requirements. But item I of Art. 19 places innovation ahead of risk classification: once the device is innovative, even a Class I device must submit a clinical investigation report on itself. This is a high-frequency rejection reason GRZAN sees when the Chinese mainland companies launch new low-risk products in Brazil.

Second judgment: in organizing evidence, literature first and investigation second — the order cannot be reversed. Art. 16 §1 requires the report to reflect the state of the art, to be scientifically sound, and to cover all aspects of the intended use of the devices within the evaluation scope. §2 expressly requires both favorable and unfavorable data to be included. A report that excerpts only favorable literature will be judged incomplete at the deficiency-response stage, and rebuilding the literature review under time pressure is far more expensive than collecting adverse data from the start.

Third trade-off: clinical data generated abroad can in principle be used, but the sole paragraph of Art. 17 points investigations conducted in Brazil separately to ANVISA’s own provisions, meaning that once a company decides to run a clinical investigation in Brazil, the local procedure applies and an offshore protocol cannot simply be transplanted onto Brazilian soil.

Fourth judgment: IVDs run on the same principles but exit into a different regulation. RDC 830/2023 returns IVDs to their dedicated regime, whose marketing authorization validity matches that of medical devices (10 years, Art. 12). For mixed device-plus-IVD product lines, GRZAN recommends sharing the literature search and evidence-grading methodology across both lines, but issuing reports and update plans per product line, so that one report does not straddle two regimes with an unclear scope.

Fifth judgment: clinical evidence must land in a fixed place in the technical dossier. Art. 57 of RDC 751/2022 requires the dossier to follow the structure of Annex II, and Art. 58 requires organization by risk class, with Chapter 4 being the clinical evidence summary. GRZAN’s practice is to make the clinical evaluation report the master document of Chapter 4 and to hang the literature search strategy, the evidence-grading table and the unfavorable-data list as annexes under the same chapter, so that evidence is not scattered across the dossier at review time.

4. Practical recommendations

• Run the innovation self-assessment first: whether design, raw materials or indications constitute an innovation, and record the conclusion in the project file.
• Build the clinical evaluation report on three elements: evidence level, coverage of all intended uses, and favorable and unfavorable data presented side by side.
• If Art. 18 is triggered, plan the clinical investigation early instead of waiting for the deficiency notice.
• Where an investigation will run in Brazil, map the ANVISA local procedure and GCP requirements separately.
• For mixed product lines, share the search strategy and evidence-grading method, but issue reports and update plans per product.
• Marketing authorization validity is 10 years (Art. 11 of RDC 751/2022); schedule periodic clinical evaluation updates into the revalidation plan.

5. Verification checklist

• □ Has the device been assessed against Art. 19 items I or II?
• □ Are the literature search strategy and the evidence-level appraisal documented?
• □ Are unfavorable data included with analysis?
• □ Does the evaluation scope cover all intended uses being claimed?
• □ Has the manufacturer set the update frequency, with records kept?
• □ Where an investigation runs in Brazil, has the ANVISA local procedure been mapped separately?

Regulatory information verified as of October 29, 2026

GRZAN Regulatory Team

GRZAN prepares Brazil-ready clinical evaluation reports, innovation determinations and clinical investigation plans aligned with Arts. 15 to 19 of RDC 848/2024, and structures clinical evidence into Annex II Chapter 4 of the technical dossier. For clinical evidence support in Brazil, contact GRZAN at info@grzanglobal.com.