Regulation (EU) 2017/745 of the European Parliament and of the CouncilShow full title

5. INVASIVE DEVICES U.K.

5.1. Rule 5 U.K.

All invasive devices with respect to body orifices, other than surgically invasive devices, which are not intended for connection to an active device or which are intended for connection to a class I active device are classified as:

• class I if they are intended for transient use;

• class IIa if they are intended for short-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity, in which case they are classified as class I; and

• class IIb if they are intended for long-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity and are not liable to be absorbed by the mucous membrane, in which case they are classified as class IIa.

All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to a class IIa, class IIb or class III active device, are classified as class IIa.

5.2. Rule 6 U.K.

All surgically invasive devices intended for transient use are classified as class IIa unless they:

• are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body, in which case they are classified as class III;

• are reusable surgical instruments, in which case they are classified as class I;

• are intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system, in which case they are classified as class III;

• are intended to supply energy in the form of ionising radiation in which case they are classified as class IIb;

• have a biological effect or are wholly or mainly absorbed in which case they are classified as class IIb; or

• are intended to administer medicinal products by means of a delivery system, if such administration of a medicinal product is done in a manner that is potentially hazardous taking account of the mode of application, in which case they are classified as class IIb.

5.3. Rule 7 U.K.

All surgically invasive devices intended for short-term use are classified as class IIa unless they:

• are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body, in which case they are classified as class III;

• are intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system, in which case they are classified as class III;

• are intended to supply energy in the form of ionizing radiation in which case they are classified as class IIb;

• have a biological effect or are wholly or mainly absorbed in which case they are classified as class III;

• are intended to undergo chemical change in the body in which case they are classified as class IIb, except if the devices are placed in the teeth; or

• are intended to administer medicines, in which case they are classified as class IIb.

5.4. Rule 8 U.K.

All implantable devices and long-term surgically invasive devices are classified as class IIb unless they:

• are intended to be placed in the teeth, in which case they are classified as class IIa;

• are intended to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are classified as class III;

• have a biological effect or are wholly or mainly absorbed, in which case they are classified as class III;

• are intended to undergo chemical change in the body in which case they are classified as class III, except if the devices are placed in the teeth;

• are intended to administer medicinal products, in which case they are classified as class III;

• are active implantable devices or their accessories, in which cases they are classified as class III;

• are breast implants or surgical meshes, in which cases they are classified as class III;

• are total or partial joint replacements, in which case they are classified as class III, with the exception of ancillary components such as screws, wedges, plates and instruments; or

• are spinal disc replacement implants or are implantable devices that come into contact with the spinal column, in which case they are classified as class III with the exception of components such as screws, wedges, plates and instruments.