Risk classification of medical devices

Understand the general risk classification system for medical devices, as well as the rules and factors that determine risk class.

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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
A Low risk Wheelchairs or tongue depressors
B Low to moderate risk Hypodermic needles or suction equipment
C Moderate to high risk Ventilators or bone fixation plates
D 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.

Classification rules

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

For the risk classification rules, please refer to GN-13 Guidance on the Risk Classification of General Medical Devices located in Guidance documents for medical devices.

In vitro diagnostic (IVD) medical devices

IVD medical device classification system

The table below indicates the four risk classes of IVD 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
A Low individual risk and low public health risk Specimen receptacle
B Moderate individual risk or low public health risk or both Vitamin B12, pregnancy self testing, anti-nuclear antibody, urine test strips
C High individual risk or moderate public health risk or both Blood glucose self testing, HLA typing, PSA screening, Rubella IgM
D High individual risk and high public health risk HIV blood donor screening, HIV diagnostic kit

Factors influencing risk classification

A number of factors affect IVD medical device risk classification. These include:

  • Determining if the product fulfils the definition of an IVD medical device in its intended purpose and the indications for use.
  • Taking into consideration the rules for proper classification. Where an IVD medical device has multiple intended purposes as specified by the product owner, which places the device into more than one class, it should be classified to the higher class.
  • If two or more risk classification rules apply to the IVD medical device, it is assigned the highest risk class.
  • The justification for placing a product in a particular risk class should be documented.

Other factors to consider include:

  • Calibrators intended to be used with an IVD reagent should be treated in the same class as the IVD reagent.
  • Control materials with quantitative or qualitative assigned values intended for one specific analyte or multiple analyte should be placed in the same class as the IVD reagent(s).

Software used with IVD medical devices

  • Most software is incorporated into the IVD medical device itself, for example, embedded software to operate an analyser. For such software, where it controls or influences the intended output of a separate IVD medical device, it will have the same class as the IVD medical device itself.
  • There is some software that is not incorporated (embedded) into the medical device itself, such as software to provide an analysis based on the results from the analyser. Such software is deemed to be standalone software. When it is not incorporated in an IVD medical device, it is classified in its own right using the classification rules.

Classification rules

The risk classification of each IVD 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 IVD medical devices

For the risk classification rules, please refer to GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices located in Guidance documents for medical devices.