Glossary Term
High-Risk Devices
Definition
High-risk devices are medical devices that present a significant potential risk to patient safety if they fail to perform as intended. These devices typically include those that are life-supporting, life-sustaining, or implanted into the body. High-risk devices are subject to the most stringent regulatory controls, including rigorous clinical evaluation, premarket approval (PMA), and post-market surveillance.
Relevance to the MedTech Industry
High-risk devices are designed to address critical healthcare needs, such as supporting vital functions, diagnosing life-threatening conditions, or providing therapeutic interventions. Their development and regulation are vital to ensuring patient safety while delivering innovative solutions for complex medical challenges.
Additional Information & Related Terms
Examples of High-Risk Devices
Implantable Cardioverter Defibrillators (ICDs): Devices that detect and treat life-threatening arrhythmias.
Artificial Heart Valves: Replace malfunctioning heart valves to maintain proper blood flow.
Deep Brain Stimulators: Implantable devices used to treat neurological conditions like Parkinson’s disease.
Spinal Cord Stimulators: Devices for managing chronic pain by delivering electrical impulses to the spinal cord.
Key Regulatory Requirements
Premarket Approval (PMA): Required for high-risk devices in the U.S., demanding clinical data and a detailed risk-benefit analysis.
EU MDR Class III: High-risk devices in the EU must meet stringent requirements under the Medical Device Regulation (MDR), including clinical investigation and notified body review.
Risk Management: Compliance with ISO 14971 to identify, evaluate, and mitigate risks throughout the device lifecycle.
Post-Market Surveillance (PMS): Ongoing monitoring of device performance and adverse event reporting.
Related Terms
Class III Medical Devices (FDA): High-risk devices as categorized by the FDA.
Post-Market Surveillance (PMS): Essential for monitoring the safety and performance of high-risk devices.
Premarket Approval (PMA): The FDA’s most rigorous regulatory pathway for high-risk devices.
ISO 14971: A standard for risk management critical in the development of high-risk devices.