medical device
Meaning of medical device: Regulatory oversight for medical devices generally scales with risk, so a simple bandage faces far less scrutiny than an implanted pacemaker.
Definition of medical device
A medical device is an instrument, apparatus, machine, implant, or similar article intended to be used for a medical purpose, such as diagnosing, monitoring, preventing, or treating a disease or condition, without achieving its primary intended action through a chemical reaction within the body, a feature that generally distinguishes a device from a drug.
Medical devices span an extremely broad range of complexity, from simple items such as bandages, tongue depressors, and thermometers, to more complex diagnostic equipment such as imaging machines, and further to implanted devices such as pacemakers, artificial joints, and stents that remain within the body indefinitely.
Because medical devices vary so widely in complexity and risk, regulatory oversight generally scales accordingly, with simple, low risk devices facing comparatively limited requirements before use, while more complex or implanted devices are subject to more extensive evaluation intended to establish their safety and effectiveness.
Used in a sentence
The cardiologist recommended an implanted medical device to help regulate the patient's heart rhythm.
Good to know
What distinguishes a medical device from a drug is generally that a device does not achieve its primary effect through a chemical action within the body, a distinction that determines its regulatory pathway.