Wearable ECG Monitor: Regulations, Standards and Guidance

Wearable ECG Monitor: Regulations, Standards and Guidance

Wearable ECG monitors have changed the face of cardiac patient care. The device provides patients with mobility, increased freedom, convenience and ability to record ECG within a minute. It eliminates the critical time needed to attach the lead wires, the issue of false alarm due to their entanglement, and are very helpful for clinician and paramedics in case of emergencies.

The wearable ECG monitor band typically has 3 electrodes and a user interface with a button to switch on the system. It has a display to show the time remaining to complete an ECG examination and the patient’s heart rate. The system also includes a micro-USB port to be connected to a tablet or laptop to retrieve, view and print the ECG obtained during an examination. A wearable ECG monitor can be used to capture arrhythmia in patients.

Regulation, Guidance and Standards:

Country : USA

Device Class : Class II

Regulation Number : 870.2340, Prod code – DPS

Regulation Description : Electrocardiograph

Submission Type and Requirements : 510(k), Est registration and listing, 21 CFR Part 820

Country : Canada

Device Class : Class II

Regulation Number : CMDR SOR/98-282

Regulation Description : Canadian Medical Device Regulations

Submission Type and Requirements : MDL, MDSAP and MDEL registration

Country : Australia

Device Class : Class IIb

Regulation Number : Classification rule 4.3

Regulation Description : Therapeutic Goods (Medical Devices) Regulations

Submission Type and Requirements : Technical File, inclusion of the device on ARTG

Country : Europe

Device Class : Class IIb

Regulation Number : Rule 10

Regulation Description : MDR

Submission Type and Requirements : Conformity assessment (CE Marking) based on a quality management system (QMS) and on assessment of technical documentation

FDA provides guidance on the review and premarket 510(k) application through its Diagnostic ECG guidance (Including non-alarming ST-segment measurement) document. In addition to complying with the test requirements, the manufacturer should comply with the following controls to get 510(k) clearance;

  • 21 CFR 801- Labelling
  • 21 CFR 807- Registration and listing
  • 21 CFR 803- Medical device related adverse event reporting
  • 21 CFR 820- Quality system regulation

Regulatory Bodies should be made aware of any adverse events that are deemed reportable.

To ensure that the product is manufactured to meet its specifications, the ma nufacturer must show compliance with 21 CFR 820, Quality system regulation. FDA does not mandate ISO 13485:2016 International standard for Quality Management System however, several countries require it. In lieu of ISO 13485:2016 certificate, Canada requires MDSAP certificate to market device in Canada.

Benefits and Risks:

Some common benefits and risks associated with a wearable ECG are as listed below.

3.1 Benefits:

  • Help screen and diagnose a variety of cardiac problem such as arrhythmia’s, heart defects, heat inflammation, cardiac arrest, poor blood supply, coronary artery disease or heart attack.
  • Helps monitor existing heart diseases

3.2 Risks:

  • User error
  • Device sensing problem
  • Software issues

Testing Requirements:

Following are required testing that needs to be completed prior to submissions:

  • IEC 60601-1-2 Medical Electrical Equipment-Part 1-2
  • IEC 60601-1-11 Medical Electrical Equipment-Part 1-11
  • ISO 6601-2-47 Medical Electrical Equipment- Part 2-47
  • ISO 10993-5 Biological Evaluation of Medical Devices-Part 5
  • ISO 10993-10 Biological Evaluation of Medical Devices-Part 10
  • ASTM D4169- 09, Standard Practice for Performance Testing of Shipping Containers and Systems
  • IEC 60601-2-25: 2011 Medical electrical equipment – Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs

For all such devices, conducting thorough testing and evaluation is the key to speedy market entry. For any questions/comments please write to jennifer@elexes.com

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