The Essential Safety and Performance Requirements (ESPR) serve as the backbone for ensuring that medical devices are not only effective but also safe for public use. These requirements cover aspects from design and manufacturing processes to post-market surveillance. Adhering to the Essential Safety and Performance Requirements (ESPR) is critical for obtaining medical device approval in any country.
ANVISA ESPR for Medical Devices in Brazil : RDC 848/2024
On March 6, 2024, ANVISA (Brazilian Health Regulatory Agency) released Resolution 848/2024 on Essential Safety and Performance Requirements (ESPR) for medical devices : to be marketed in Brazil. This regulation came into effect on September 4, 2024, following a 180-day implementation period. Resolution 848/2024 replaces the previous RDC 546/2021, which had updated earlier guidelines under RDC 56/2001.
Applicability of ANVISA RDC 848/2024
One of the most significant features of ANVISA's Resolution 848/2024 is its comprehensive inclusion of in vitro diagnostic (IVD) devices. This regulation applies to all classes of medical devices—Class I, II, III, and IV—as well as IVDs, underscoring its broad reach and the emphasis on ensuring safety and efficacy across the board.
Moreover, the requirements outlined in RDC 848/2024 are designed to be maintained throughout the entire life cycle of a medical device, from initial design through to post-market surveillance. For high-risk Class III and Class IV devices, the regulation specifically mandates that safety and performance claims be substantiated by relevant clinical data.
ANVISA Compliance Verification for RDC 848/2024
The compliance verification for medical devices and IVDs involves inspections by health surveillance authorities. This includes checks during Good Manufacturing Practices (GMP) inspections, product registration, or notifications with ANVISA, ensuring ongoing adherence to safety and performance standards.
Expanded Scope and New Considerations in RDC 848/2024
RDC 848/2024 introduces additional essential safety and performance requirements, particularly focusing on:
Software as a Medical Device (SaMD): Special considerations for devices incorporating software.
Usability by Laypeople: Addressing risks associated with devices intended for use by non-professionals.
Implantable Medical Devices: Specific requirements for devices that are implanted within the body.
Furthermore, it emphasizes the necessity for a robust quality management system, ongoing risk management, and comprehensive documentation that includes clinical evaluation and investigation data.
Comprehensive Summary of Resolution RDC No. 848
Resolution RDC No. 848 on Essential Safety and Performance Requirements (ESPR) governs the design, safety, and performance of medical devices (MD) and in vitro diagnostic devices (IVD). It emphasizes risk management, user safety, and compliance with regulatory standards to ensure effective healthcare outcomes.
Risk Management and Design Considerations
Misidentification Risks: Medical devices (MD) and in vitro diagnostic devices (IVD) must minimize risks of sample misidentification, erroneous results, and interference with other medical devices.
Fire and Explosion Safety: Devices should be designed to eliminate or reduce risks of fire or explosion during normal use and in single failure conditions, especially those interacting with flammable substances.
Maintenance and Calibration: MD and IVDs must allow safe adjustment, calibration, and maintenance. Risks related to aging materials and loss of accuracy must be addressed.
Interoperability and Security
Compatibility: Devices intended to work with others must ensure reliable interoperability.
Unauthorized Access: Designs must prevent unauthorized access that could impair functionality or pose security risks.
Ergonomics and Disposal
Usability: Measuring scales and controls should adhere to ergonomic principles for clarity and ease of use.
Disposal Procedures: Instructions must detail safe disposal or recycling of devices and associated waste.
Protection Against Electrical, Mechanical, and Thermal Risks
User Safety: Devices must protect against mechanical hazards and manage noise, vibration, and electrical discharge risks.
Temperature Control: Accessible parts must not reach dangerous temperatures during normal use.
Active Devices and Alarm Systems
Failure Condition Protocols: Active devices must have measures to mitigate risks from single failures.
Power Supply Alerts: Devices reliant on power sources must have alarms for critical status changes.
Software and Cybersecurity
Software Performance: Devices incorporating software must guarantee reliability and performance. Software development should follow current best practices, including cybersecurity measures.
User Requirements: Clear minimum hardware requirements and IT security measures must be specified.
Labeling and Instructions for Use
Identification: Clear identification information must be provided for MDs and IVDs.
Safety Information: Users must receive relevant safety and performance details, presented clearly and understandably.
Radiation Protection
Emission Safety: Devices must minimize radiation exposure while ensuring effective diagnostic capabilities.
Warning Indicators: Visual and audible warnings must be in place for devices emitting dangerous radiation.
User-Friendliness for Laypersons
Design for Accessibility: Devices intended for lay use must ensure safety and accuracy, with instructions easy for non-professionals to follow.
Verification Features: Devices should enable users to verify correct functionality.
Biological Materials
Safety Protocols: Devices using biological materials must ensure safety through strict sourcing and handling to mitigate risks from communicable agents.
Performance Standards for IVDs
Analytical Validity: IVDs must achieve the analytical and clinical performance declared by the manufacturer, with appropriate validation and testing for accuracy and reliability.
Population Representation: Performance evaluations must consider diverse user populations and environments.
A Comparative Perspective: RDC 848 and European MDR
When comparing RDC 848 with the European Medical Device Regulation (MDR) (2017/745) and General Safety and Performance Requirements (GSPRs), the similarities are striking. Many of the requirements outlined in RDC 848 align closely with those established in European regulations, indicating a move toward harmonization in medical device regulation.
Notable parallels include:
Quality Management Systems: Similar to the requirements in the MDR.
Clinical Evaluation and Investigation: Reflective of MDR standards, with additional conditions specified by ANVISA for high-risk devices.
However, it's important to note that RDC 848/2024 does not introduce major new requirements beyond what is already established in European regulations, particularly concerning medical devices (excluding IVDs).
ANVISA's Resolution 848/2024 marks a significant advancement in Brazil’s regulatory framework for medical devices. By incorporating stringent safety and performance requirements and aligning with international standards, this regulation enhances public health protection. As the medical device landscape continues to evolve, the adoption of RDC 848/2024 represents a proactive approach to ensuring the safety and efficacy of medical technologies in Brazil
Reach Out to Artixio for Support
If you have any questions or need assistance with navigating the requirements set forth in Resolution RDC No. 848, don’t hesitate to reach out to Artixio. Our expert team is here to provide you with the guidance and support you need to ensure compliance and enhance the safety and performance of your medical devices and in vitro diagnostic devices.
Contact us today at info@artixio.com to discuss your specific needs or schedule a consultation. Let Artixio be your trusted partner in achieving excellence in medical device development!
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