Class I: These are the lowest risk medical devices such as bandages, manual wheelchairs, stethoscopes. These normally contact intact skin only. Conformity assessment can be performed entirely by the manufacturer through self-declaration with no Notified Body involvement.
Class Ir: Class Ir medical device are composed of low-risk devices such as sterile bandages or surgical instruments that are reusable after appropriate procedures. In addition to general Class I requirements, these devices require Notified Body conformity assessment typically through a quality management system audit and review of technical documentation.
Class Im: Class Im medical device are also low risk devices, but ones that are also incorporating a medicinal substance like antibiotic bone cements. Notified Body must assess conformity looking at the device-drug interaction and compliance with pharmaceutical legislation and regulations.
Class IIa: Class IIa medical device are medium risk devices intended to come into contact with injured skin or bodily orifices for limited periods such as powered wheelchairs, surgical instruments, contact lenses. Conformity assessment involves Notified Body auditing of the manufacturer’s quality system and selective verification of technical documentation.
Class IIb: Class IIb medical devices present moderate to high risks, as they are often implanted in the body for over 30 days such as dental implants, orthopedic implants and Intraocular lenses. Their regulatory compliance process is similar to the one for Class IIa, with more careful safety and performance examinations.
Class III: Class III medical devices are of the highest risk category, comprised of vital life-sustaining or life-supporting products, such as heart valves and pacemakers. Due to the critical nature of Class III devices and given the tremendous risks posed by any potential failures, their regulatory compliance process is the most rigorous and demanding. Both the product design and the physical device itself must undergo extensive testing and validations, along with in-depth examinations conducted by a notified body.
Although we handle all types of devices, our expert are specializing in Class IIb implantable devices and Class III devices and have ample experience with them. Based on factors such as the device's Instructions for Use, technical specs, intended use, and other information, we can provide expert advice on applicable legislation and recommend the suitable classification and regulatory pathway strategy for your medical device, as well as help manufacturers make informed decision all throughout the development process, as early as from the R&D process.
