Brazil ESPR: RDC 848/2024 Replaces RDC 546/2021

1. Key takeaways

Article 86 of RDC 848/2024 repeals RDC 546/2021, merging medical devices and IVDs into a single set of essential safety and performance requirements (ESPR); the resolution takes effect 180 days after publication (Article 88), and ANVISA issued the effectiveness announcement on September 10, 2024. GRZAN’s judgment: the main workload of this version change lies not in new provisions but in remapping the documentation system — if the old cross-reference table is not rebuilt, it will be exposed on the spot during review.

2. Legal basis

• Essential safety and performance requirements — RDC nº 848/2024, resolution of March 6, 2024, published in the DOU on March 8, 2024, effective 180 days after publication (Article 88), effectiveness announcement issued by ANVISA on September 10, 2024, Article 1 §3, Articles 15–19, Articles 50, 51, 53, Article 81, Article 85 (violations of the essential safety and performance requirements constitute health offenses punishable under Lei nº 6.437/1977), Article 86 (repeals RDC nº 546/2021), Article 87 (grandfather clause: applications submitted before this resolution takes effect continue to be accepted under the safety and efficacy requirements of RDC nº 546/2021)
• Classification, notification and registration of medical devices, and labeling and instructions-for-use requirements — RDC nº 751/2022, resolution of September 15, 2022, Articles 5 and 11
• In vitro diagnostic medical devices — RDC nº 830/2023, published December 11, 2023 (DOU 234), effective June 1, 2024 (Article 71), Article 12

3. Expert insights

The first insight is the merger. RDC 848/2024 places devices and IVDs inside one set of principles for the first time, and Article 81 requires IVDs to demonstrate both analytical performance and clinical performance. GRZAN’s reading: where IVD teams and device teams previously each maintained their own ESPR cross-reference table, these must now be merged into one, and the organization of performance evidence has to be adjusted accordingly.

The second insight is hardening. Article 7 requires a risk management system across the full life cycle; Articles 15–19 address clinical evaluation and clinical investigation, with Article 18 making clinical investigation mandatory where data is insufficient and Article 19 listing the two situations in which clinical study reports must be submitted; Articles 50, 51 and 53 write the accuracy, reliability and cybersecurity of software-containing devices (including SaMD) as development-process requirements that must be verified, with IT requirements to be specified. GRZAN’s judgment: the common feature of these provisions is verifiability — reviewers can request evidence item by item, and vague statements no longer pass.

The third insight is the verification route. Article 1, §3 makes clear that compliance is verified through GMP inspection, marketing authorization or notification procedure, and product hygiene inspection. The version change is not a one-time act but a continuing requirement running through inspection, review and post-market surveillance. Marketing authorization validity is 10 years (Article 11 of RDC 751/2022 and Article 12 of RDC 830/2023), so maintenance costs should be spread across the whole validity period.

The fourth insight is the sanctions link: Article 85 provides that violating the essential safety and performance requirements of this resolution constitutes a health offense punishable under Lei 6.437/1977. GRZAN’s judgment: the ESPR thereby rises from a technical requirement to a punishable obligation; the cross-reference table is no longer documentation work but the boundary of sanction risk.

The fifth insight is the two key provisions of the version change itself: Article 86 repeals RDC 546/2021, and Article 87 is the grandfather clause — applications submitted before this resolution takes effect continue to be accepted under the safety and efficacy requirements of RDC 546/2021. GRZAN’s judgment: Article 87 is the most critical provision of the transition period; it ensures in-review projects will not be required mid-course to switch to the new standard, but it also means that what counts as submitted before the effective date must be supported by written evidence.

The sixth insight is handling products during the transition. RDC 848/2024 takes effect 180 days after publication (Article 88), and ANVISA issued the effectiveness announcement on September 10, 2024. Technical files previously prepared under RDC 546/2021 do not automatically lose validity, but new applications submitted after the effective date must be prepared under the new provisions. GRZAN recommends proactively submitting one cross-reference table update for in-review projects, making the mapping between old and new article numbers explicit.

The seventh insight is the link with classification rules. Article 5 of RDC 751/2022 sets risk Classes I to IV, and Articles 6 and 7 correspond to notification and marketing authorization respectively; the ESPR verification route under Article 1, §3 lands on GMP inspection, marketing authorization or notification procedure, and product hygiene inspection. GRZAN’s judgment: different classes correspond to different verification entries, and the whole chain should be sorted out during the version change.

4. Practical recommendations

• Rebuild the ESPR cross-reference table mapped to RDC 848/2024 article numbers and retire the RDC 546/2021 version.
• Add the dual evidence chain of analytical and clinical performance for IVD projects.
• Add cybersecurity and development verification records for SaMD and software-containing devices.
• Complete and file the determination on whether a clinical investigation or clinical study report is required under Articles 18 and 19.
• Phase the version change across registered and in-review products, prioritizing Classes III/IV.
• Proactively submit a cross-reference table update for in-review projects, marking the old-to-new article number mapping.
• Sort out the ESPR verification entries by risk class (GMP inspection / marketing authorization or notification / product hygiene inspection).

GRZAN also notes the practical pressure the version change puts on smaller companies: RDC 848/2024 consolidates previously scattered requirements into one set of verifiable provisions — for companies this is a re-architecture of the document structure, not a simple article-for-article swap. Running a gap analysis early costs less time than reworking item by item through deficiency letters.

5. Verification checklist

• □ Verify that technical documentation is mapped to RDC 848/2024 rather than RDC 546/2021
• □ Verify the completeness of IVD dual-performance evidence (Article 81)
• □ Verify coverage of the SaMD / software-containing device provisions (Articles 50, 51, 53)
• □ Verify the records of clinical evaluation and clinical investigation determinations (Articles 15–19)
• □ Verify that cross-reference tables for in-review projects have been updated in step
• □ Verify that ESPR verification entries match the risk class
• □ Verify that the gap analysis covers the entire product line
• □ Verify that the sanction link of Article 85 is written into the compliance matrix (under Lei 6.437/1977)
• □ Verify the submission dates of in-review projects against the Article 87 grandfather clause
• □ Verify the original text of Articles 85, 86, 87 and 88 of RDC 848/2024 against the DOU

Regulatory information verified as of October 29, 2026

GRZAN Regulatory Team

GRZAN manages ESPR version changes for Brazil from end to end: cross-reference table rebuilds under RDC 848/2024, IVD and SaMD evidence upgrades, gap analyses across the product line, and review support for in-flight applications under the grandfather clause. We turn a documentation overhaul into a controlled project instead of a deficiency-letter treadmill. For ESPR and regulatory documentation support in the Brazilian market, contact info@grzanglobal.com.