Navigate regulatory pathways and standards for ABPM devices with confidence
What is an Ambulatory Blood Pressure Monitor?
1. Continuous Monitoring
Portable device that automatically measures BP at set intervals over 24 hours during daily activities
2. Programmable Schedule
Takes readings more frequently during day, less frequently at night for comprehensive assessment
3. Data Analysis
Downloads to computer software for calculating averages, patterns, and nocturnal dipping analysis
How ABPM Technology Works
1. Sbsillo Oscillometric Cuff Inflation
Automated cuff inflates around patient’s arm at programmed intervals
2. Arterial Wall Detection
Microprocessor detects oscillations in arterial wall during deflation process
3. Pressure Calculation
Device derives systolic, diastolic, and mean arterial pressures from oscillation patterns
4. Data Recording
Measurements stored with timestamps for comprehensive 24-hour profile analysis
Regulatory Classification Overview
| FDA Classification | EU MDR Classification |
| Class II Device | Typical Class Ila |
| Requires 510(k) premarket notification | Active device for monitoring vital physiological processes (Rule 10) |
| Guidance Available | Note: Final classification depends on intended purpose, duration, invasiveness, and device activity |
| Non-Invasive Blood Pressure (NIBP) Monitor 510(k) guidance | Always reference Annex VIII + Document: DA-2020-D-0957 MDCG 2021-24 |
| Document: DA-2020-D-0957 |
Essential Standards for ABPM Compliance
1. ISO 81060-2
Clinical Investigation Standard
Covers clinical investigation requirements for automated sphygmomanometers including validation protocols
2. IEC 80601-2-30
Safety & Performance Standard
Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers
Important: Always review the complete scope of standards before applying them to your specific device configuration
Ready to Navigate Your ABPM Regulatory Journey?
Expert regulatory support for ambulatory blood pressure monitor approvals in US and EU markets
Standards Sanity Check
Verify applicable standards for your device configuration
Pre-filled GSPR
General Safety Performance Requirements documentation
Risk Management File
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