Eu Rules for the classification of medical devices

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• 2023-2-20

Medical devices in the European Union are divided into four categories: I, IIa, IIb and III. These four categories overlap and intersect with the categories of non-invasive devices, invasive devices, and active devices.

Rules applicable to non-invasive devices or equipment

For non-invasive devices, the general principle is that in principle all non-invasive devices belong to Class I, with three exceptions. (Rule 1)

In exception 1, all non-invasive devices used to transport or store blood, body fluids, cells or tissues, fluids or gases for final infusion, administration or introduction into the body are in principle Class I, but (1) are classified as Class IIa if they can be connected to Class IIa, Class IIb or Class III active devices; (2) if their intended use is for the delivery or storage of blood or other bodily fluids, or for the storage of organs, organ parts, cells and tissues of the body, other than blood bags; (3) Blood bags are classified as Class IIb. (Rule 2)

(1) All devices or devices used to modify biological or chemical components of human tissue or cells, blood, other body fluids, or other fluids used for implantation or administration are classified as Class IIb; However, if the device is used in filtration devices, gas, heat centrifugal exchange devices, they are classified as class IIa. (2) All non-invasive devices or devices that contain a substance or mixture intended for use in isolated cells, tissues or organs, or for use in vitro fertilization, are classified as Class III. (Rule 3)

Exception 3: All non-invasive devices or devices whose intended use is to contact damaged skin or mucous membranes (1) are classified as Class I if they are intended for use with a mechanical barrier, such as compression or infiltration; (2) If they are mainly used for dermal rupture of skin injury or mucosal injury, and can only be repaired by secondary, classified as class IIb; (3) If they are mainly used for the microenvironment management of damaged skin or mucous membranes, they are classified as class IIa; (4) Other cases are classified as IIa; (5) The above rules also apply to invasive devices or devices that remove damaged mucous membranes. (Rule 4)

Rules applicable to invasive devices or devices

All invasive devices or devices related to body holes, excluding surgical invasive devices or devices not intended to be connected to active devices or only to Class I active devices, (1) are classified as Class I if their service life is "transient"; (2) If the service life is "short term", classified as class IIa; Such devices used in the oropharynx are classified as class I; (3) If the service life is "long-term", it is classified as class IIb; Such devices used in the oropharynx and are not easily absorbed by the mucosa are classified as class IIa. (Rule 5-1)

All invasive devices or devices associated with body holes are classified as Class IIa, excluding surgical invasive devices or devices intended to be connected to Class IIa, IIb, or III active devices. (Rule 5-2)

All surgical invasive instruments or devices with a "transient" service life shall be classified as Class IIa. (1) Devices or devices specifically designed to control, diagnose, or correct cardiac defects or the central circulatory system through direct contact with parts of the body are classified as Class III; (2) Repeated use of surgical instruments, classified as Class I; (3) Devices or devices specifically intended for direct contact with the heart, central circulatory system or central nervous system, classified as Class III; (4) Where energy is provided in the form of ionizing radiation, it is classified as Class IIb; (5) For use in the drug delivery system, if the delivery of the drug in a manner potentially risky, classified as Class IIb. (Rule 6)

All surgical invasive instruments or devices with a "short" service life should be classified as Class IIa. (1) Devices or devices specifically designed to control, diagnose, or correct cardiac defects or the central circulatory system through direct contact with parts of the body are classified as Class III; (2) Devices or devices specifically intended for direct contact with the heart, central circulatory system or central nervous system, classified as Class III; (3) Have biological effects, can be fully or largely absorbed, classified as class III; (4) Those that undergo chemical changes in the body are classified as class IIb, except those that are installed on the teeth; (5) Those used for drug administration are classified as Class IIb. (Rule 7)

All implantable devices or devices or surgical invasive devices or devices with a "long-term" service life shall be classified as Class IIb. Except in the following cases: (1) devices on the teeth, classified as class IIa; (2) Devices or devices specifically intended for direct contact with the heart, central circulatory system or central nervous system, classified as Class III; (3) Have biological effects, can be fully or largely absorbed, classified as class III; (4) Those that undergo chemical changes in the body are classified as Class III, except those that are installed on the teeth; (5) For drug administration, classified as Class III; (6) Active implantable devices or their accessories, classified as Class III; (7) Breast implants or surgical patches, classified as Class III; (8) Total or partial joint replacement, classified as Class III, except screws, wedges, plates, hand-held devices and other auxiliary devices or equipment; (9) Implants for disc replacement, or implantable devices that directly disarm the spine, are classified as Class III, with the exception of auxiliary devices or devices such as screws, wedges, plates, and hand-held devices. (Rule 8)

Applicable rules for active devices or equipment

In principle, all active devices or equipment are classified as Class I; The following are exceptions for active devices or equipment. (Rule 13)

All therapeutic devices or devices used for drug administration or energy exchange are classified as Class IIa when there is a potential risk in the way they manage energy or exchange energy with the human body, especially when the nature, density and site of action of energy are taken into account. (Rule 9-1)

All active devices or equipment used to control or monitor active therapeutic Class IIb devices or equipment, or used directly to affect the performance of such devices or equipment, are classified as Class IIb. (Rule 9-2)

All active devices or devices that emit ionizing radiation for therapeutic purposes, including those that control or monitor such devices or that directly affect the performance of such devices, are classified as Class IIb. (Rule 9-3)

All active devices or devices used to control, monitor, or directly affect an active implanted device or device are classified as Class III. (Rule 9-4)

All active devices or equipment used for diagnosis and monitoring are classified as IIa if: (1) they are used to provide energy that can be absorbed by the body; Such devices that illuminate the patient's body in the visible spectrum are classified as Class I; (2) For imaging radiopharmaceutical distribution in vivo; (3) For direct diagnosis or monitoring of key physiological processes; This device does not contain specific monitoring of key physiological parameters that may pose an immediate risk to the patient and the properties of changes in these parameters, such as changes in cardiac function, breathing, central nervous system activity, or clinical diagnosis where the patient is at immediate risk, in which case it is classified as Class IIb. (Rule 10-1)

All active devices or devices used to emit ionizing radiation or diagnostic/therapeutic radiation, including those that access radiological devices or devices and control such devices or directly affect the performance of such devices, are classified as Class IIb. (Rule 10-2)

All software should be classified as Class I, with the following two exceptions. (Rule 11-3)

In exception 1, all active devices or devices used to provide decision-making information for diagnosis or treatment are classified as Class IIa; (1) Death or irreversible deterioration of health are classified as Class IIb; (2) Serious deterioration of health or surgical intervention is classified as class IIb. (Rule 11-1)

Exception 2, software used to monitor physiological processes, is classified as Class IIa; The software is classified as Class IIb, except for the monitoring of key physiological parameters whose variation characteristics can lead to an immediate risk to the patient. (Rule 11-2)

All active devices that administer or remove drugs, bodily fluids or other substances from the body are classified as Class IIa; If the work is performed in a manner that contains potential risks, in particular the properties of the substance involved, the part of the body and the mode of application, the active device or equipment shall be classified as Class IIb. (Rule 12)