When marketing medical devices around the globe, manufacturers face the significant challenge of meeting requirements of multiple regulatory agencies. An important component of achieving regulatory approval is classification of the medical device, according to the specific regulatory body. This classification generally signifies the device’s designated level of risk. It also provides a road map for regulatory approval, from design to development to market, whether that approval is needed from the Food and Drug Administration (FDA) in the US, the European Union’s European Database on Medical Devices (EUDAMED), or China’s National Medical Products Administration (NMPA). These agencies tend to use the same terminology, e.g., Class I, Class II, and Class III, but their rules and requirements within those classifications are not uniform – and therein lies the challenge. Here is a rundown of how regulatory bodies in the US, EU, South Korea, and China classify medical devices.
The FDA oversees medical device regulations through its branch called the Center for Devices & Radiological Health (CDRH). The CDRH assigns devices to three classes, based on the degree of control necessary to ensure safety and effectiveness, intended use, and indications for use. Classification of the medical device will determine the type of premarketing submission or applications required for FDA clearance to market.
• Class I (low to moderate risk)
• Class II (moderate to high risk)
• Class III (high risk)
Devices within Class I and II may be exempt or non-exempt from a 501(k) premarket notification requirement that demonstrates safety and effectiveness. Class III devices typically require premarket approval (PMA), the FDA process of scientific and regulatory review to evaluate safety and effectiveness. The FDA has classified and described over 1,700 distinct types of devices and organized them into the Code of Federal Regulations according to 16 medical specialty panels; manufacturers can access a classification database maintained by the FDA when determining how to classify their medical devices.
The European Commission Regulation (EU) No. 2017/745, commonly known as the Medical Device Regulation (MDR), originally was set for implementation in May 2020 but was pushed back a year due to the COVID-19 epidemic. The MDR groups medical devices into four classes, and under the new regulation system, the class of many devices may have changed to meet stricter rules. The new classifications tend to be more in line with international regulations, but can differ in aspects of regulatory approval. Approved medical devices achieve a CE marking, a necessity for entering the European market.
Class 1 (low to medium risk): Non-invasive devices. Manufacturers must complete a Technical File as part of the approval process but in most cases will not require certification by a Notified Body, an outside body accredited by the EU to conduct regulatory audits and ensure MDR requirements are met.
Subgroups of this class include :
- Class 1s for sterile devices and Class 1m for low-risk measurement devices; these subgroups will require Notified Body assessment.
- Class IIa (medium risk): Medium-risk devices placed within the body for short term use, 60 minutes to 30 days. Requires assessment by a Notified Body.
- Class IIb (medium to high risk): Medium- or high-risk devices placed within the body for 30 days or longer. Requires assessment by a Notified Body.
- Class III (high risk): Devices of highest risk are those that will undergo permanent monitoring by specialized institutions. To achieve approval, these devices will require a full quality assurance system audit, plus examination of the device and the device’s design by a Notified Body.
South Korea regulations classify medical devices into four groups, based on increasing risk. The MFDS lists the following classifications with examples of non-IVD devices.
- Class 1 (very low risk) – ophthalmic microscope, stethoscope
- Class II (low risk) – pulse oximeter
- Class III (moderate risk) – silk suture
- Class IV – (high risk) – implantable defibrillator
Classifications with examples of IVD medical devices
- Class 1 (very low risk) – specimen transport media
- Class II (low risk) – IVD reagents for allergy test or urine chemistry
- Class III (moderate risk) – IVD strip for glucose self-test
- Class IV – (high risk) – IVD reagents for diagnosis of HIV/HBV/HCV
Most Class 1 medical devices are exempted from technical review and certification procedures. The exceptions are sterile and measuring devices, which are regulated like Class II devices. Classes II, III, and IV will require either a General Technical File or Safety and Effectiveness Review.
China bases medical devices classifications according to the degree of regulatory oversight that will be needed. The classification system is based on the Medical Device Classification Catalog, which identifies categories, subcategories, example of device names, product descriptions and intended use.
- Class I – low-risk; safety and effectiveness ensured through routine administration
- Class II – mid-risk; require further control to ensure safety and effectiveness
- Class III – high risk; devices implanted in the human body, used to support or sustain life; must be strictly controlled
China adopted new medical device regulations in 2020, which went into effect in June 2021. Among the changes: only high-risk Class III medical devices need clinical trial approval. Some products are no longer categorized as medical devices, including sleep monitors and dental denture molding fluid, and other devices were re-classified, e.g., optical endoscope is now Class II instead of Class III, and oral imaging aids are Class I instead of Class II.
Published guidance continues to develop for health authorities and can be quite nuanced, as indicated by past learning experiences with the US FDA. The health authorities in this blog are served as active channels for machine-to-machine submissions via Reed Tech SingleSource™ for Medical Devices.
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South Korea MFDS