Device Area

Overview

Current State

Future State

Spinal implantable medical devices

Implantable devices that are intended to be a motion-preserving device for the spine or that come into contact with the spinal column will be reclassified from Class IIb to Class III.

Spinal fusion implantable devices, such as screws, cages, plates, hooks or rods that are used during spinal fusion surgical procedures, will remain classified as Class IIb.

Implantable devices that are intended to be a motion-preserving device for the spine or that come into contact with the spinal column are currently classified as Class IIb.

Spinal fusion implantable devices are currently classified as Class IIb.

Implantable devices that are intended to be a motion-preserving device for the spine or that come into contact with the spinal column will be classified as Class III.

Spinal fusion implantable devices will remain classified as Class IIb.

All spinal implantable medical devices must be selected for an application audit.

Active medical devices for therapy with diagnostic function

Devices intended to significantly determine patient management by the device (e.g. closed loop systems or automated external defibrillators) will be reclassified from Class IIa/Class IIb to Class III.

Currently Class IIa/Class IIb.

Reclassified to High Risk Class III.

Note: It is intended that continuous positive airway pressure (CPAP) machines will remain Class IIb.

Active implantable medical devices and their accessories

Active implantable medical devices (AIMD) and long-term surgically invasive and implantable accessories to AIMD will be classified as Class III.

Active implantable medical devices are currently classified as Class AIMD.

Class III

Medical devices that administer medicines or biologicals by inhalation

All invasive medical devices intended to administer medicines or biologicals by inhalation will be classified as Class IIa, unless their mode of action has an essential impact on the efficacy and safety of the administered therapeutic good or they are intended to treat life-threatening conditions, in which case they will be classified as Class IIb.

Class I or Class IIa

Class IIa or ClassIIb

Medical device that consist of substances introduced into the body via a body orifice or applied to the skin

Devices composed of substances, or combinations of substances, that are intended to be introduced into the human body through an orifice or applied to the skin, and to be absorbed by, or locally dispersed, in the human body after introduction or application will be classified as either Class III, Class IIa or Class IIb, consistent with rule 21 of Chapter III of Annex VIII of EU Regulation 2017/745.

Class I – Class IIa

Class IIa. Class IIb or ClassIII

Medical devices used in direct contact with the heart, central circulatory or central nervous systems

Surgically invasive medical devices intended for use in contact with the heart, CCS or the CNS will be classified as Class III (high risk) medical devices.

Class IIa

Class III