A medical device
is a device that is used for medical purposes. Because of their potential for harm, they must be approved before they are used.
There are two primary types of medical devices: invasive and non-invasive. The former is meant to support biological functions, such as breathing or heartbeat, while the latter is used to treat symptoms. A non-invasive device, such as a thermometer, can be placed in an opening in the body without causing any kind of harm. Active devices, on the other hand, depend on a source of energy other than the human body to perform their intended function.
Despite the similarities among classification systems, there are some significant differences. Classification systems vary from country to country. A medical device's classification can significantly affect its route to market. In countries with stricter regulatory requirements, a device's classification may be more complex. Nevertheless, getting this right will help manufacturers avoid lengthy delays.
Classification of medical devices in the U.S.
The FDA regulates the safety and effectiveness of many types of medical devices before they are available for sale in the United States. These devices fall into three different classifications, according to their risk levels. Low-risk devices include bandages and hand-held surgical instruments, while intermediate-risk devices include pacemakers, intravenous medications, and MRI scanners. High-risk devices are the most serious and require pre-market approval before they can be sold.
To determine if a device is safe to use, the FDA first defines what it is. The device is then classified according to its primary intended use and indications for use. Indications for use are either contained on the device's label, or communicated orally to the consumer during the sale of the product. There are also specialized indications for use. The FDA has established several requirements for medical devices, including compliance requirements for their manufacture and marketing.
Classification of medical devices in Europe
Unlike the US, where medical devices are categorized based on function and use, the classification of medical devices in Europe is based on risk. Medical devices are classified as either Class I or Class II, depending on the type and duration of contact with the body. Classification is also based on the invasive nature of the device, its diagnostic impact, and whether it incorporates a medicinal product. Each type of device must meet the requisites of the European Directive before it can be placed on the market.
The new MDR brings the classification of medical devices in Europe more in line with the international regulatory framework. This has simplified many aspects of regulatory approval, including the use of labelling and titration. The MDR classification for medical devices is based on the strictest rule that applies to a particular device. If a device is categorized incorrectly, it may not be marketed or even sold in the EU.
Classification of medical devices in Canada
There are a few rules governing the classification of medical devices in Canada. Firstly, the intended use of a device should be identified in the labeling. This information should be present in all documents accompanying the device. Furthermore, the classification rules of a medical device should be risk-based and should consider the likely occurrence of adverse events. Health Canada's guidance document provides detailed information about the classification rules and outlines the main requirements for the application of each rule.
In Canada, the Food and Drugs Act defines medical devices as instruments that help diagnose, treat, or mitigate disease. There are two distinct classification systems in Canada. First, Class I devices don't require licensing. Second, Class II devices require the applicant to demonstrate that they are safe and effective. Third, Class III devices require more evidence and documentation to demonstrate their safety and effectiveness. Fourth, Class V devices must undergo a rigorous certification process with the Canadian Nuclear Safety Commission.