Understanding the regulation for non-active medical devices for approval
Non-active medical devices are those that do not require the application of electrical or mechanical energy in order to perform their function. Some examples of non-active medical devices include low-risk items such as bandages, examination gloves, and hospital consumables, to medium-risk products like sterile disposable syringes, needles and infusions sets and contact lenses, to higher-risk devices such as dialysers, blood bags or bone screws, to devices that pose the highest level of risk, including cardiovascular implants, joint replacement products, neurosurgical implants, drug/device combination products and medical devices incorporating materials of animal or human origin.
Similar to regulations for all types of medical devices, the selection of applicable regulations for non-active medical devices depend on the intended use of the device, the amount or length of anticipated human contact, and the degree of risk that the device presents to a patient or healthcare worker. However, because there are many different types of non-active medical devices, determining the regulatory requirements applicable to a specific device is often a complex process. In addition, regulations are continuously changing as products based on new technologies are introduced.
In evaluating third-party organisations, manufacturers of non-active medical devices should consider several factors. The most qualified organisations are likely to have experts with a range of expertise in various scientific and technical fields, including clinical (medicine), chemistry, biology, microbiology, pharmaceutical research and materials science. Extensive experience with a variety of medical device types and applications is also important. In-depth knowledge of regulatory requirements in all major markets is essential.