Medical Devices

The tables below provides some examples of the articles available in the InsHeal Content Repository on Medical Devices (table 1) and Medical Device Regulations (table 2). The articles on Class I Medical Devices (EU MDR), Class I Medical Devices Conformity Assessment (EU MDR) and pulse oximeters is available as sample articles. For further details and sample articles, please reach out to us at: insheal@insiwi.co.in.

Table 1. Medical Devices

TopicDescription
Continuous glucose monitorsContinuous glucose monitors measure the glucose levels from the fluid surrounding the cells of the body through sensors attached to the skin. They obliviate the need for repeated finger pricks particularly in patients on insulin treatment.
Graduated Compression StockingsGraduated compression stockings are stockings that provide maximum pressure at the ankles, which reduces upward towards the top of the garment. They provide relief from the pain and swelling caused by conditions such as varicose veins and lymphedema. They should be prescribed by the treating physician.
Home blood glucose meter / glucometer The glucometer is a portable device that is useful for diabetes patients on insulin or those who suffer from fluctuations in the blood glucose level. An understanding of the features available of the device, and the cost of the device as well as its accessories is important before selecting the most appropriate device for an individual.
Home blood pressure monitors The home blood pressure monitor is a portable device that enables hypertensive patients to record their blood pressure in their natural surroundings. It allows patients to have a better understanding and control of their blood pressure.
Home ECG monitorsHome ECG monitors record the electrical activity of the heart in the comfort of one’s home. Devices that use multiple leads are usually preferred over single-lead devices for accuracy. These devices supplement but are not a replacement for a heart examination at a hospital or a clinic.
Home NebulizersNebulizers are devices that convert a liquid medicine into extremely small particles that can be inhaled and have a direct effect on the lungs. It is recommended for people with breathing disorders who find it difficult to use a metered-dose inhaler.
MR Elastography MR Elastography is a radiology test that is used to check the liver stiffness in diseases like hepatitis B, alcoholic liver disease, and non-alcoholic liver disease.
N95 masks The N95 masks protect against occupational pollutants, and have more recently been used to protect against COVID-19 infections. The correct use of the mask is important to ensure the maximum benefit.
Non-invasive Glucose MonitorsNon-invasive glucose monitors measure the blood glucose levels through sensors temporarily attached to the skin. Some are CE marked and approved to monitor the blood glucose levels in people with type 2 diabetes, but cannot be currently used to make treatment decisions.
Pulse oximeters Pulse oximeters measure the oxygen saturation of the blood. They have become a household name during the COVID pandemic.
Thermometers – Digital and InfraredDigital and infrared thermometers have replaced mercury temperature to measure body temperature. The popularity of the non-contact infrared thermometers increased during the COVID-19 pandemic. The correct method of measurement is necessary to obtain the correct body temperature.
Wearable Fitness / Activity TrackersWearable fitness trackers measure the daily activities and help individuals to reach their goals towards physical fitness. The devices vary with respect to their features, accuracy and price.

Table 2. Medical Devices Regulations

TopicDescription
Class I Medical Devices (EU MDR)Medical devices are classified as a class I devices under the European Union Medical Device Regulation when they pose the least risk to the patient.
Class I Medical Devices – Conformity Assessment (EU MDR)Medical devices have to undergo a conformity assessment procedure to obtain certification under the European Union Medical Device Regulation. The procedure for class I devices is the simplest since these devices pose the least risk to the patient.
Class IIa Medical Devices (EU MDR)Medical devices are classified as class IIa devices under the European Union Medical Device Regulation when their risk is between those of class I and class IIb devices. They include some non-invasive, some invasive and some active devices.
Class IIa Medical Devices – Conformity Assessment (EU MDR)Medical devices have to undergo a conformity assessment procedure to obtain certification under the European Union Medical Device Regulation. There are two conformity assessment routes that can be followed to obtain the CE mark for class IIa medical devices.
Class IIb Medical Devices (EU MDR)Class IIb devices are medical devices that pose a considerable risk to the patient. While most of these are invasive devices, some non-invasive devices are also included in this group.
Class IIb Devices – Conformity assessment routes (EU MDR)Medical devices have to undergo a conformity assessment procedure to obtain certification under the European Union Medical Device Regulation. There are three conformity assessment routes that can be followed to obtain the CE mark for class IIb medical devices.
Class III Medical Devices (EU MDR)Class III medical devices included in the European Union Medical Device Regulation carry the highest risk and are often in contact with vital organs such as the heart and the central nervous system. Most of the devices are invasive devices.
Class III Devices – Conformity Assessment Routes (EU MDR)Medical devices have to undergo a conformity assessment procedure to obtain certification under the European Union Medical Device Regulation. Class III devices have to undergo extensive processes before they obtain the CE certification.
Regulatory Approvals and Certifications for Medical DevicesMedical devices that are approved by the US Food and Drug Administration, are CE certified or are certified based on the ISO 13485 standards have high standards of quality and safety. The approval or certification should be verified before purchase to rule out devices with fake claims.
Summary of Safety and Clinical PerformancesThe summary of safety and clinical performances is a requirement of the European Union Medical Devices Regulation (EU MDR) for certain high-risk medical devices. It describes the safety of a medical device.

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