Brazil ESPR under RDC 848/2024: compliance as a status, not a certificate

1. Key takeaways

The Essential Safety and Performance Requirements (ESPR) in Brazil are not a standalone submission item. RDC 848/2024 enters into force 180 days after publication (Art. 88), and ANVISA issued the effective-date notice on September 10, 2024. There is no separate ESPR certificate a company can apply for: compliance is verified inside three other regulatory scenarios. GRZAN’s position is that the watershed between a smooth Brazilian project and an expensive detour is understanding ESPR as a status to be maintained rather than a document to be filed once. Because verification is embedded in inspections, approval procedures and market surveillance, a strategy of assembling evidence only at submission time is structurally doomed, and evidence must instead be organized so that it can be produced on demand at any point across the entire validity period of a registration or notification.

2. Legal basis

• Essential Safety and Performance Requirements — RDC No. 848/2024, published in the DOU on March 8, 2024 (decided on March 6, 2024), Art. 1 §3, Arts. 85, 86 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, effective March 1, 2023 (Art. 67), Art. 10 §7, Arts. 11, 57 and 58
• Brazilian Good Manufacturing Practices — RDC No. 665/2022, published on March 30, 2022, effective May 2, 2022 (Art. 138), Art. 1
• Law on Sanitary Infractions and Penalties — Lei No. 6.437/1977, dated August 20, 1977, published in the DOU on August 24, 1977 (Part 1, page 11145), full text

3. Expert insights

Art. 1 §3 names the three verification scenarios: good manufacturing practice inspections, marketing authorization or notification procedures, and product sanitary inspections. The design intent is clear. ANVISA does not intend to open a separate review channel for the ESPR; it embeds the requirements into existing procedures so that the same principles are checked repeatedly at the factory, in the dossier and in the market. For companies, this means the strategy of completing evidence just before submission no longer works, because each of the three scenarios can surface gaps independently, on its own timetable, years after the file was approved.

The most common pitfall GRZAN sees in Brazilian projects is treating the ESPR as a checkbox list. Companies tick through the articles clause by clause, generate a cross-reference table and submit it, but Art. 10 §7 of RDC 751/2022 expressly ties the maintenance of notifications and marketing authorizations to good manufacturing practices, the ESPR and specific regulations. In other words, across the 10-year validity period, ESPR compliance is continuously tested rather than screened once at intake. A cross-reference table that is never refreshed will silently diverge from the device as actually manufactured, and the divergence is precisely what a later inspection will find.

The second pitfall is the transition from the old rules. Art. 86 replaces RDC 546/2021, and companies that still number their historical technical files by the old principles will produce a cross-reference table with structural misalignment when they organize legacy documentation. The third judgment: the ESPR for the first time merges medical devices and IVDs into one set of principles. Companies running both product lines can share a single principles framework, but IVDs carry the dual-performance requirement of Art. 81 and cannot simply reuse a device-side template.

Fourth judgment: the ESPR and the submission route interact. Class I (low risk) and Class II (medium risk) follow the notification route (notificação); Class III (high risk) and Class IV (highest risk) follow registration (registro, RDC 751/2022 Arts. 6 and 7). The notification route involves no technical review, yet ESPR compliance is still checked within the three scenarios listed in Art. 1 §3, so companies must not relax evidence preparation merely because no technical review applies.

Fifth judgment: the technical dossier is the vehicle of the ESPR, and its structure cannot be self-invented. RDC 751/2022 requires the technical dossier to follow the structure of Annex II (Art. 57), organized in tiers by product risk class (Art. 58). Annex II aligns with the nIVD MA ToC of IMDRF/RPS WG/N9 Ed.3:2019. Its Chapter 3 concentrates the current list of ESPRs (applicable to Classes II–IV only), electromagnetic compatibility and electrical system safety, biocompatibility, pyrogenicity, sterilization validation, cleaning and disinfection of reusable devices, and shelf life and packaging validation; Chapter 4 is the clinical evidence summary. GRZAN’s practice is to attach the ESPR cross-reference table directly to Chapter 3 of Annex II, so that articles, evidence and dossier chapters correspond on three sides and a reviewer can walk from any requirement to its proof without intermediate explanation.

Sixth judgment: anchor the ESPR table to the article-number ranges of Annex I instead of inventing in-house numbering. The first layer of Annex I splits into Part A (general ESPRs), Part B (ESPRs for non-IVD medical devices) and Part C (ESPRs for IVDs), with continuous chapter numbering: Part A covers Arts. 1–58, Part B covers Arts. 59–131, and Part C covers Arts. 132–174, with Art. 174 falling at the end of Part C. GRZAN’s practice is to cite Part B article numbers directly in the cross-reference table and to list Arts. 129, 130 and 131 — software, computing, hardware, IT networks and cyberattacks — separately. This way, deficiency responses can point straight at official articles without explaining the mapping between in-house numbering and official numbering.

Seventh judgment: the evidence cost of the ESPR should be amortized into the product design phase. ANVISA looks back at design inputs in both the GMP inspection scenario and the product sanitary inspection scenario. Companies that convert ESPR articles into a design-input list at project kickoff see a marked reduction in the later cost of supplementary evidence. This is a trade-off GRZAN has validated across multiple Brazilian projects, and it consistently pays for itself long before the first inspection.

4. Practical recommendations

• When building the ESPR cross-reference table, mark evidence sources in three columns — factory, dossier and market — instead of a single column of ticks.
• Point every article in the table to a specific document number and version, so evidence can be retrieved on the spot during GMP site inspections.
• Projects submitted after the effective date follow RDC 848/2024; run a gap comparison for legacy projects and retain the old-to-new mapping for reference.
• State the exclusion rationale for each non-applicable article; never leave the non-applicable field blank.
• Build notification-route files (Classes I/II) against the ESPR as well; the absence of technical review is no reason to simplify.
• The GMP scenario under RDC 665/2022 covers design, purchasing, production, packaging, labeling, storage and transport, installation and technical assistance across the whole chain; evidence should map to these stages.
• Violating the ESPR constitutes a sanitary infraction under Art. 85 and triggers the penalty list of Lei 6.437/1977. Fines follow the infraction grading (leve / grave / gravíssima), with amounts set by current rules — the original amounts in Art. 5 of Lei 6.437/1977 were priced in 1977 cruzeiros, a currency that ceased to be legal tender after successive monetary reforms, so this series does not list amounts — and penalties may be accompanied by sales bans and cancellation of the marketing authorization.

5. Verification checklist

• □ Is the cross-reference table based on RDC 848/2024 rather than RDC 546/2021?
• □ Does every non-applicable article carry a written exclusion rationale?
• □ Are factory-side evidence items (BGMP under RDC 665/2022) in place?
• □ Do dossier-side evidence items cover both routes: Class I/II notification and Class III/IV registration?
• □ Is the post-market maintenance mechanism embedded in the quality system with a designated responsible person?
• □ Has a Brazil-side ESPR compliance contact been designated, with duties that do not conflict with those of the registration holder or the technical responsible person?
• □ Is the ESPR cross-reference table hooked to the corresponding entries of Chapter 3 of Annex II of the technical dossier?

Regulatory information verified as of October 29, 2026

GRZAN Regulatory Team

GRZAN supports medical device and IVD manufacturers entering the Brazilian market with complete registration dossiers under RDC 751/2022 and RDC 830/2023, BGMP certificates under RDC 665/2022, ESPR cross-reference tables and conformity documentation under RDC 848/2024, Portuguese labeling and IFU localization, and change-control maintenance across the full validity period. For dossier preparation, gap assessment and submission support in Brazil, contact GRZAN at info@grzanglobal.com.