Risk assessment constitutes the methodological foundation for the regulation of medical devices globally, with particular relevance in the Brazilian regulatory landscape. This article explores the fundamentals, methodologies, and regulatory implications of risk assessment, with a specific focus on the normative context of ANVISA and its correlations with international standards.
Methodological Fundamentals of Risk Assessment
ISO 14971 defines risk assessment as the “systematic process of identifying hazards and estimating the associated risks.” In the context of medical devices, this process is fundamentally quantitative and qualitative, incorporating:
- Systematic identification of potential hazards
- Probabilistic analysis of occurrence
- Estimation of the severity of consequences
- Evaluation of the detectability of the risk before the manifestation of harm
The risk matrix used in the evaluation of medical devices typically incorporates three main variables:
- Severity (S): Consequence of the materialized risk (scale 1-5)
- Occurrence (O): Probability of manifestation (scale 1-5)
- Detectability (D): Ability to identify beforehand (scale 1-5)
Brazilian Regulatory System and Risk Classification
ANVISA’s Normative Structure
ANVISA implements a risk-based classification system through specific normative instruments, notably RDC 751/2022, which establishes the minimum requirements for:
- Registration and notification of medical devices
- Risk-based categorization criteria
- Documentary requirements proportional to the risk class
- Scalable post-market controls
Technical Classification Criteria
The Brazilian system adopts a four-risk class approach with specific technical criteria:
| CLASS | RISK LEVEL | PRIMARY TECHNICAL CRITERIA | EXAMPLES |
| I | Low | Non-invasive; temporary contact; non-critical systems | Stethoscopes, stretchers |
| II | Medium | Transient invasive; connected to a power source or not; monitoring | Infusion pumps, peripheral catheters |
| III | High | Long-term invasive; vital support; non-critical implantable | Joint prostheses, non-medicated stents |
| IV | Maximum | Critical implantable; combination with drugs; emerging technologies | Heart valves, drug-eluting stents |
This classification structure has a direct correlation with international systems, such as the FDA (Classes I, II, III) and the European system (Classes I, IIa, IIb, III), facilitating regulatory harmonization.
Impact of Risk Assessment on the Regulatory Process
The classification resulting from the risk assessment directly determines:
- Regulatory pathway: Higher-risk devices require more rigorous approval routes.
- Extent of documentation: Higher risk requires more clinical and non-clinical data.
- GMP (Good Manufacturing Practices) requirements: More stringent manufacturing standards.
- Post-market: More intensive monitoring and safety reports.
Risk Assessment Methodology
The process generally follows these steps:
- Risk identification: Mapping all potential risks of the device.
- Risk analysis: Evaluating the probability and severity of each risk.
- Risk evaluation: Determining if the risk level is acceptable.
- Risk control: Implementing measures to mitigate identified risks.
- Continuous monitoring: Follow-up after commercialization.
The Importance of MDSAP and Harmonized Approaches
MDSAP represents a significant advancement in regulatory harmonization, allowing a single audit to satisfy the requirements of multiple jurisdictions, including:
- Brazil (ANVISA)
- USA (FDA)
- Canada (Health Canada)
- Australia (TGA)
- Japan (MHLW/PMDA)
The technical implementation of MDSAP involves:
- Process-based audit: Focused on seven critical quality system processes.
- Integrated risk assessment: Adapting the audit scope to the risk profile.
- Harmonization of non-conformities: Using a uniform categorization system.
- Structured reports: Facilitating evaluation by multiple agencies.
Technical Implications for Manufacturers
Integrating with MDSAP requires specific technical adaptations:
- Implementation of harmonized process controls.
- Cross-mapping of regional regulatory requirements.
- Adaptation of technical documentation to a unified format.
- Establishment of KPIs compatible with the expectations of multiple jurisdictions.
Conclusion
Risk assessment is not just a regulatory requirement but an essential component to ensure the safety and efficacy of medical devices.
In the Brazilian context, a deep understanding of the technical methodologies of risk assessment and their proper application represents a critical factor for regulatory success.
Manufacturers who adequately understand and implement this process not only facilitate regulatory approval but also ensure safer devices for patients.
For international medical device companies seeking access to the Brazilian market, the implementation of risk assessment strategies aligned with ANVISA’s expectations, with particular attention to the specifics of RDC 751/2022 and harmonization via MDSAP, constitutes a differentiating element for regulatory efficiency. Relying on specialized consulting in medical regulation can be crucial to navigate ANVISA’s complex risk assessment system.
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