Classification of Medical Devices Based on UK MDR 2002

The classification of medical devices in the UK market will be based on UK MDR 2002 from 1st January 2021. Medical devices are classified into a particular class based on the level of risk they pose to the patient and according to the intended purpose of use.

The medical devices are classified based on the classification rules in Annex IX of Directive 93/42 into one of the following four classes:

• Class I – Medical device which poses low to moderate risk to the patient
• Class IIa – Medical device which poses a moderate risk to the patient
• Class IIb – Medical device which poses a moderate to high risk to the patient
• Class III – Medical device which poses a high risk to the patient 

The medical devices are classified into the above-given classes based on 18 rules mentioned in Annex IX of Directive 93/42.

These 18 rules are majorly divided into four parts which are non-invasive devices, invasive devices, active devices and special rules.

• Devices that do not penetrate inside the body fall under non-invasive
• Devices that penetrate inside the human body either through a body orifice or through the surface of the body are Invasive devices (this also includes surgically invasive devices)
• Devices that require an external energy source come under active devices
• All other devices falling outside of these categories come under Special rules

In the event of a dispute between a manufacturer and a notified body over the classification of a device, the matter shall be referred to the Secretary of State, who shall determine the classification of the device in accordance with the classification criteria set out in Annex IX of Directive 93/42.

Few Common examples of the various classes discussed above:

• Class I  – Bandage, Spectacle Frames, Surgical Masks, Wheelchair
• Class IIa – Suture Needles, Hearing Aids, Surgical clamps
• Class IIb – Infusion pumps, Surgical Laser, Ventilator
• Class III – Pacemaker, defibrillator, Cochlear implants

Rules to Remember for UK MDR 2002

• Medical devices which are used in a particular combination are also individually classified into their specific class
• Software that is used to aid the operation of a particular medical device also falls into the same class as the medical device
• The medical device that is not explicitly designed for a particular part of the body is be classified based on the most critical use of that device
• If multiple rules apply to a particular medical device, the rule which involves the highest risk must be considered for the classification purpose

4 General Procedure of Medical Devices Based on UK MDR 2002

1. Decide the type of device that you are about to classify into a non-invasive, invasive, active, or special category.
2. Look at each UK MDR 2002 classification rule and determine which rule applies to your medical device.
3. If multiple rules apply for your device apply the highest risk rule.
4. If the product is combined determine its principal mode of action with respect to its intended purpose and apply the most suitable rule.

• Once the medical device is successfully classified into a particular class, the registration process or the conformity assessment for that medical device will be based on the derived risk class of the device. Hence Classification of the medical device plays an integral role in the registration process of a medical device