General medical devices
General risk classification system
The table below indicates the four risk classes of medical devices. The examples given are for illustration only and the product owner must apply the risk classification rules to each medical device according to its intended purpose.
| Risk class
|| Risk level
|| Medical device examples
|| Low risk
|| Wheelchairs or tongue depressors
|| Low to moderate risk
|| Hypodermic needles or suction equipment
|| Moderate to high risk
|| Ventilators or bone fixation plates
|| High risk
|| Heart valves or implantable defibrillator
Factors influencing risk classification
A number of factors affect medical device risk classification. These include:
- The duration of medical device contact with the body.
- The degree of invasiveness.
- Whether the medical device delivers medicinal products or energy to the patient.
- Whether they are intended to have a biological effect on the patient.
- Local versus systemic effects (e.g. conventional versus absorbable sutures).
Based on the product owner’s intended purpose, if two or more risk classification rules apply to the medical device, the medical device is assigned the highest risk class.
If one medical device is intended to be used together with another medical device, the risk classification rules shall apply separately to each of the medical devices. This is regardless of whether they are from the same product owner (e.g. a physiological monitor and a separate recorder, or a general purpose syringe and a syringe driver).
Collection of medical devices
The risk classification of a collection of medical devices that individually comply with all regulatory requirements depends on the product owner’s purpose in packaging and marketing. For example:
- If the combination results in a product that is intended to meet a purpose different from that of the individual medical devices that make it up, the combination is considered a new medical device should be classified accordingly.
- If the combination is for the convenience of the user but does not change the intended purposes of the individual medical devices that make it up (e.g. a customised kit that provides all the medical devices necessary to carry out a particular surgical procedure), the risk class assigned to the collection should be the same as that of the medical device with the highest risk class included within. This is for the purpose of a Declaration of Conformity28 KB.
Accessories used with medical devices
Accessories intended to be used specifically with a medical device to help in its function shall be subjected to the regulatory requirements that apply to the medical device itself (e.g. essential principles for safety and performance, post-market surveillance, etc).
Software used with medical devices
Most software is incorporated into the medical device itself (e.g. embedded software to operate an electrocardiogram).
Some software applications are not embedded into the medical device itself (e.g. software applications to analyse electrocardiogram signals on a computer independent of the electrocardiogram). These are deemed to be standalone software and fall within the scope of the definition for a medical device, and should be classified as follows:
- Where it drives or influences the use of a separate medical device, it should be classified according to the intended purpose of the combination.
- Where it is independent of any other medical device, it is classified in its own right using the rules.
- Standalone software is deemed to be an active medical device.
The risk classification of each medical device depends on the design and claims made by the product owner and on its intended purpose.
The notes for consideration and illustrative examples for each rule are meant to aid interpretation of each rule's purpose only.
The actual risk classification of each medical device must be considered individually, taking into account their design and intended purpose.
Rules for general medical devices