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.

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 

Rule 1: Non-invasive devices which come into contact with injured skin

Rule Notes for consideration and illustrative examples of devices that may conform with a rule
All non-invasive devices which come into contact with injured skin: N.A.
Are in Class A if they are intended to be used as a mechanical barrier, for compression or absorption of exudates only, for wounds that heal by primary intention. Examples: Compression bandages, cotton wool
Are in Class B if they are intended to be used to manage the microenvironment of the wool Examples: Non-medicated impregnated gauze dressings
Unless they are intended to be used principally with wounds that cannot heal by primary intent, in which case they are in Class C. Devices used to treat wounds where the subcutaneous tissue is at least partially exposed and the edges of the wound are not sufficiently close to be pulled together. To close the wound, new tissue must be formed within the wound prior to external closure. The product owners claims that they promote healing through physical methods other than 'primary intent'.

Examples: Dressings for chronic ulcerated wounds; dressings for severe burns.

Rule 2(i): Non-invasive devices for channeling tissues, or channeling or storing body liquids or gases

Rule Notes for consideration and illustrative examples of devices that may conform with a rule
All non-invasive devices intended for channeling tissues or channeling or storing body liquids or gases for the purpose of eventual infusion, administration or introduction into a human body are in Class A. Such devices are 'indirectly invasive' in that they channel or store liquids that will eventually be delivered into the body (see comment for Rule 4).

Examples: Administration sets for gravity infusion; syringes without needles
Unless they are intended to be connected to an active medical device in Class B or a higher class, in which case they are in Class B. Examples: Syringes and administration sets for infusion pumps, anaesthesia breathing circuits.

Note: "Connection" to an active device covers those circumstances where the safety and performance of the active device is influenced by the non-invasive device and vice versa.

Rule 2(ii): Non-invasive devices for channeling blood or blood components, or storing organs or body tissues

Rule Notes for consideration and illustrative examples of devices that may conform with a rule
All non-invasive devices intended for channeling blood or blood components, or storing organs, parts of organs or body tissues
for the purpose of eventual infusion, administration or introduction into a human body are in Class B.
Examples: Tubes used for blood transfusion, organ storage containers, tissue and cell containers.
Unless they are blood bags, in which case they are in Class C. Examples: Blood bags, blood component storage bags

Rule 3: Non-invasive devices for modifying the biological or chemical composition of blood, other body liquids or other liquids for infusion

Rule Notes for consideration and illustrative examples of devices that may conform with a rule
All non-invasive devices intended for modifying the biological or chemical composition of blood, other body liquids or other liquids intended for infusion into the body are in Class C. Such devices are indirectly invasive in that they treat or modify substances that will eventually be delivered into the body (see note to comment for Rule 4). They are normally used in conjunction with an active device within the scope of either Rule 9 or Rule 11.

Examples: Haemodialysers; devices to remove white blood cells from whole blood.

Note: For the purpose of this part of the rule, 'modification' does not include simple, mechanical filtration of centrifuging which are covered below.
Unless the intended modification is carried out by filtration, centrifuging or exchanges of gas or of heat, in which case they are Class B.
Examples: Devices to remove carbon dioxide; particulate filters in an extracorporeal circulation system.

Rule 4: Non-invasive devices that do not come in contact with the patient or in contact with intact skin only

Rule Notes for consideration and illustrative examples of devices that may conform with a rule
All other non-invasive devices that do not come into contact with the patient or contact intact skin only are in Class A. These devices either do not touch the patient or contact intact skin only.

Examples: Urine collection bottles; compression hosiery; non-invasive electrodes, hospital beds.

Rule 5: Non-surgically invasive devices i.e. devices which are invasive through body orifices only

Rule Notes for consideration and illustrative examples of devices that may conform with a rule
All invasive devices with respect to body orifices (other than those which are surgically invasive) and which:
  • Are not intended to be connected to an active medical device, or
  • Are intended to be connected to a Class A medical device only.
Such devices are invasive in body orifices and are not surgically invasive. Devices tend to be diagnostic and therapeutic instruments used in ENT, ophthalmology, dentistry, proctology, urology and gynaecology. Classification depends on the duration of use and the sensitivity (or vulnerability) of the orifice to such invasion.
Are in Class A if they are intended for transient use. Examples: Examination gloves; enema devices.
Unless they are intended for transient use on the external surface of the eyeball, and are liable to be absorbed by the mucous membrane, in which case they are in Class B. Examples: Wetting or lubricating eye drops.
Are in Class B if they are intended for short-term use. Examples: Urinary catheters, tracheal tubes.
Unless they are intended for short-term use in the oral cavity as far as the pharynx, in an ear canal up to the ear drum, or in a nasal cavity, and are not liable to be absorbed by the mucous membrane in which case they are in Class A. Examples: Dentures intended to be removed by the patient; dressings for nose bleeds.
Are in Class C if they are intended for long-term use. Example: Urethral stent.
Unless they are intended for long-term use in the oral cavity as far as the pharynx, in an ear canal up to the ear-drum, or in a nasal cavity, and are not liable to be absorbed by the mucous membrane, in which case they are in Class B. Examples: Orthodontic wire, fixed dental prosthesis.
All invasive devices with respect to body orifices (other than those which are surgically invasive) that are intended to be connected to an active medical device in Class B or a higher class, are in Class B. Examples: Tracheal tubes connected to aventilator; suction catheters for stomach drainage.

Note: Independent of the time for which they are invasive.

Rule 6: Surgically invasive devices intended for transient use (less than 60 minutes)

Rule Notes for consideration and illustrative examples of devices that may conform with a rule
All surgically invasive devices intended for transient use are in Class B. A majority of such devices fall into several major groups: those that create a conduit through the skin (e.g. syringe needles; lancets), surgical instruments (e.g. single- use scalpels; surgical staplers; single-use aortic punch); surgical gloves; and various types of catheter/sucker, etc.

Note:
  • A surgical instrument (other than those in Class D) is in Class A if reusable and in Class B if supplied sterile and intended for single use. Also, a surgical instrument connected to an active device is in a higher class than A.
  • If the device incorporates a medicinal substance in a secondary role, refer to Rule 13.
Unless they are reusable surgical instruments, in which case they are in Class A; or Examples: Manually operated surgical drill bits and saws.
Unless intended to supply energy in the form of ionising radiation, in which case they are in Class C; or Example: Catheter incorporating/containing sealed radioisotopes.
Unless intended to have a biological effect or to be wholly or mainly absorbed by the human body, in which case they are in Class C; or Note:
  • The ‘biological effect’ referred to is an intended one rather than unintentional. The term ‘absorption’ refers to the degradation of a material within the body and the metabolic elimination of the resulting degradation products from the body.
  • This part of the rule does not apply to those substances that are excreted without modification from the body.
Unless intended to administer medicinal products by means of a delivery system, if this is done in a manner that is potentially hazardous taking into account the mode of application, in which they are in Class C; or Example: Insulin pen for self-administration.

Note: The term ‘administration of medicines’ implies storage and/or influencing the rate/volume of medicine delivered not just channelling. The term ‘potentially hazardous manner’ refers to the characteristics of the device and not the competence of the user.
Unless they are intended specifically for use in direct contact with the central nervous system, in which case they are in Class D; or N.A.
Unless intended specifically to diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class D. Examples: Angioplasty balloon catheters and related guide wires; dedicated disposable cardiovascular surgical instruments.

Rule 7: Surgically invasive devices intended for short-term use (between 60 minutes and 30 days)

Rule Notes for consideration and illustrative examples of devices that may conform with a rule
All surgically invasive devices intended for short-term use are in Class B. Such devices are mostly used in the context of surgery or post-operative care, or are infusion devices, or are catheters of various types.

Examples: Infusion cannulae; temporary filling materials; non-absorbable skin closure devices; tissue stabilisers used in cardiac surgery.

Note:
  • Includes devices that are used during cardiac surgery but do not monitor or correct a defect.
  • If the device incorporates a medicinal substance in a secondary role refer to Rule 13.
Unless they are intended to administer medicinal products, in which case they are in Class C; or Note: The term ‘administration of medicines’ implies storage and/or influencing the rate/volume of medicine delivered not just channelling.
Unless they are intended to undergo chemical change in the body (except if the devices are placed into the teeth), in which case they are in Class C; or Example: Surgical adhesive.
Unless they are intended to supply energy in the form or ionising radiation, in which case they are in Class C; or Example: Brachytherapy device.
Unless they are intended to have a biological effect or to be wholly or mainly absorbed by the human body, in which case they are in Class D; or Example: Absorbable suture; biological adhesive.

Note: The ‘biological effect’ referred to is an intended one rather than unintentional. The term ‘absorption’ refers to the degradation of a material within the body and the metabolic elimination of the resulting degradation products from the body.
Unless they are intended specifically for use in direct contact with the central nervous system, in which case they are in Class D; Example: Neurological catheter.
Unless they are intended specifically to diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class D. Examples: Cardiovascular catheters; temporary pacemaker leads; carotid artery shunts.

Rule 8: Implantable devices and surgically invasive devices for long-term use (more than 30 days)

Rule Notes for consideration and illustrative examples of devices that may conform with a rule
All implantable devices, and long-term surgically invasive devices, are in Class C. Most of the devices covered by this rule are implants used in the orthopaedic, dental, ophthalmic and cardiovascular fields.

Example: Maxilla-facial implants; prosthetic joint replacements; bone cement; non- absorbable internal sutures; posts to secure teeth to the mandibula bone (without a bioactive coating).

Note: If the device incorporates a medicinal substance in a secondary role refer to Rule 13.
Unless they are intended to be placed into the teeth, in which case they are in Class B; or Examples: Bridges; crowns; dental filling materials.
Unless they 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 in Class D; or Examples: Prosthetic heart valves; spinal and vascular stents.
Unless they are intended to be life supporting or life sustaining, in which case they are in Class D; or N.A.
Unless they are intended to be active implantable medical devices, in which case they are Class D; or Example: Pacemakers, their electrodes and their leads; implantable defibrillators.
Unless they are intended to have a biological effect or to be wholly or mainly absorbed, in which case they are in Class D; or Example: Implants claimed to be bioactive.
Unless they are intended to administer medicinal products, in which case they are in Class D; or Example: Rechargeable non-active drug delivery system.
Unless they are intended to undergo chemical change in the body (except if the devices are placed into the teeth), in which case they are in Class D; or N.A.
Unless they are breast implants, in which case they are in Class D. N.A.

Rule 9(i): Active therapeutic devices intended to administer or exchange energy with the human body, or that are softwares

Rule Notes for consideration and illustrative examples of devices that may conform with a rule
All active therapeutic devices that are intended to administer or exchange energy to or with the human body, or that are software are in Class B. Such devices are mostly electrically powered equipment used in surgery; devices for specialised treatment and some stimulators.

Examples: Muscle stimulators; transcutaneous Electro-Neuro Stimulator (TENS) devices; powered dental hand pieces; hearing aids; neonatal phototherapy equipment; ultrasound equipment for physiotherapy, software and mobile application intended to treat diseases or conditions.
Unless their characteristics are such that they function in a potentially hazardous way, including ionising radiation, taking into account the nature, the density and site of application of the energy, in which case they are in Class C.
Examples: Lung ventilators; baby incubators; electrosurgical generators; external pacemakers and defibrillators; surgical lasers; lithotriptors; therapeutic X- ray and other sources of ionising radiation.

Note: The term ‘potentially hazardous’ refers to the type of technology involved and the intended application.

Rule 9(ii): Active devices to control or monitor the performance of active therapeutic devices

Rule Notes for consideration and illustrative examples of devices that may conform with a rule
All active devices intended to control or monitor the performance of active therapeutic devices in Class C or higher, or intended directly to influence the performance of such devices, are in Class C.
Examples: External feedback systems for active therapeutic devices.

Rule 10(i): Active devices for diagnosis

Rule Notes for consideration and illustrative examples of devices that may conform with a rule
Active devices intended for diagnosis are in Class B.
Such devices include equipment for ultrasonic diagnosis/imaging, capture of physiological signals, interventional radiology and diagnostic radiology.

If they are intended to supply energy which will be absorbed by the human body (except for devices used solely to illuminate the patient's body, with light in the visible or near infra-red spectrum, in which case they are Class A), or Examples: Magnetic resonance equipment; diagnostic ultrasound in non-critical applications; evoked response stimulators.
If they are intended to image in vivo distribution of radiopharmaceuticals, or Example: Gamma/nuclear cameras.
If they are intended to allow direct diagnosis, or monitoring of vital physiological processes, Example: Electronic thermometers, stethoscopes and blood pressure monitors; electrocardiographs.

Note: Vital physiological processes and parameters include, for example respiration, cerebral functions, blood gases, blood pressure, body temperature, etc.
Unless they are specifically intended for:
  • Monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of central nervous system, or
  • Diagnosing in clinical situations where the patient is in immediate danger, in which case they are in Class C.
Example: Monitors/alarms for intensive care; biological sensors; oxygen saturation monitors; apnoea monitors; ultrasound equipment for use in interventional cardiac procedures.

Note: Medical devices intended to be used for continuous surveillance of vital physiological processes in anaesthesia, intensive care or emergency care are in Class C, whilst medical devices intended to be used to obtain readings of vital physiological signals in routine check-ups and in self-monitoring are in Class B.

Rule 10(ii): Active devices intended to emit ionising radiation and intended for diagnostic or interventional radiology devices

Rule Notes for consideration and illustrative examples of devices that may conform with a rule
Active devices intended to emit ionising radiation and intended for diagnostic and/or interventional radiology, including devices which control or monitor such devices, or those which directly influence their performance, are in Class C.
Example: These include devices for the control, monitoring or influencing of the emission of ionising radiation.

Rule 11: Active devices to administer or remove medicinal products, body liquids or other substances from the body

Rule Notes for consideration and illustrative examples of devices that may conform with a rule
All active devices intended to administer and/or remove medicinal products, body liquids or other substances to or from the body are in Class B.
Such devices are mostly drug delivery systems.

Examples: Suction equipment; feeding pumps; jet injectors for vaccination; nebuliser to be used on conscious and spontaneously breathing patients where failure to deliver the appropriate dosage characteristics is not potentially hazardous.
Unless this is done in a manner that is potentially hazardous, taking into account the nature of the substances involved, the part of the body concerned and the mode and route of administration or removal, in which case they are in Class C. Examples: Infusion pumps; anaesthesia equipment; dialysis equipment; hyperbaric chambers; nebuliser where the failure to deliver the appropriate dosage characteristics could be hazardous.

Rule 12: All other active devices not covered in rules 9, 10 or 11 above

Rule Notes for consideration and illustrative examples of devices that may conform with a rule
All other active devices are in Class A.
Examples: Examination lamps; surgical microscopes; powered hospital beds & wheelchairs; powered equipment for the recording, processing, viewing of diagnostic images; dental curing lights.

Rule 13: Devices with registrable therapeutic or medicinal substances in a secondary role

Rule Notes for consideration and illustrative examples of devices that may conform with a rule
All devices incorporating, as an integral part, a substance which, if used separately, is a registrable therapeutic/medicinal product, and which is liable to act on the human body with action ancillary to that of the devices, are in Class D.
These medical devices incorporate medicinal substances in an ancillary role.

Examples: Antibiotic bone cements; drug eluting stents; wound dressings incorporating antimicrobial agents to provide ancillary action on the wound.

Note:
  • “Integral part" means that the device and the therapeutic/medicinal substance are physically or chemically combined at the time of administration (i.e. use, implantation, application, etc) to the patient.
  • This rule does not apply to products that incorporate therapeutic/medicinal substances that are not intended to act on the human body e.g. catheter surface modification or coating with silver or heparin substances that is solely intended to protect the catheter.

Rule 14: Devices manufactured from or incorporating cells, tissues or derivatives of cells or tissues

Rule Notes for consideration and illustrative examples of devices that may conform with a rule
All devices manufactured from or incorporating:
  • Cells, tissues or derivatives of cells or tissues of animal origin, rendered non-viable, or
  • Derivatives of cells or tissues of human origin, rendered non-viable, or
  • Cells, tissues or derivatives of cells or tissues of recombinant origin are Class D.
Examples: Porcine heart valves; catgut sutures.
Unless such devices are manufactured from or incorporate non-viable animal tissues or their derivatives that come in contact with intact skin only, where they are in Class A. Examples: Leather components of orthopaedic appliances.

Rule 15: Devices specifically used for sterilising medical devices, or disinfecting as the end point of processing

Rule Notes for consideration and illustrative examples of devices that may conform with a rule
All devices intended specifically to be used for sterilising medical devices, or disinfecting as the end point of processing, are in Class C.
Examples: Devices for disinfecting orsterilising endoscopes; disinfectants intended to be used with medical devices.

Note: This rule does not apply to products that are intended to clean medical devices by means of physical action e.g. washing machines.
Unless they are intended for disinfecting medical devices prior to end point sterilisation or higher level disinfection, in which case they are in Class B; or Example: Washer disinfectors.

Unless they are intended specifically to be used for disinfecting or hydrating contact lenses, in which case they are in Class C. N.A.

Rule 16: Devices used for contraception or the prevention of the transmission of sexually transmitted diseases

Rule Notes for consideration and illustrative examples of devices that may conform with a rule
All devices used for contraception or the prevention of the transmission of sexually transmitted diseases are in Class C.
Examples: Condoms; contraceptive diaphragms.
Unless they are implantable or long-term invasive devices, in which case they are in Class D. Example: Intrauterine contraceptive device.

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.
  • Standalone control materials with quantitative or qualitative assigned values intended for one specific analyte or multiple analytes should be placed in the same class as the IVD reagents.
  • Standalone control materials with no assigned values intended for use with multiple or single analytes should not be placed in the same class as the IVD reagents.

Software used with IVD medical devices

Most software is incorporated into the IVD medical device (e,g, embedded software to operate an analyser).

Some software applications are not embedded into the medical device (e.g. software to provide an analysis based on the results from the analyser). These are deemed to be standalone software and fall within the scope of the definition for a IVD medical device, and should be classified as follows:

  • Where it controls or influences the intended output of a separate IVD medical device, it will have the same classification as the IVD medical device.
  • Where 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 

Rule 1: IVD medical devices used to detect the presence or exposure to transmissible agents in blood, tissues or organ intended for transfusion or transplantation, or those that cause life-threatening diseases with high risk of propagation

IVD medical devices intended for at least one the following purposes are classified as Class D:

  • Devices intended to be used to detect the presence of, or exposure to, a transmissible agent in blood, blood components, blood derivatives, cells, tissues or organs in order to assess their suitability for transfusion or transplantation.
  • Devices intended to be used to detect the presence of, or exposure to, a transmissible agent that causes a life-threatening, often incurable, disease with a high risk of propagation.

Rationale

The application of this rule as defined above should be in accordance with the rationale that follows: IVD medical devices in this class are intended to be used to ensure the safety of blood and blood components for transfusion and/or cells, tissues and organs for transplantation.

In most cases, the result of the test is the major determinant as to whether the donation/product will be used. Serious diseases are those that result in death or long-term disability, which are often incurable or require major therapeutic interventions and where an accurate diagnosis is vital to mitigate the public health impact of the condition.

Examples: Tests to detect infection by HIV, HCV, HBV, HTLV. This rule applies to first-line assays, confirmatory assays and supplemental assays. 

Rule 2: IVD medical devices used for blood grouping or tissue typing to ensure the immunological compatibility for transfusion or transplantation

IVD medical devices intended to be used for blood grouping, or tissue typing to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation, are classified as Class C, except for ABO system \[A (ABO1), B (ABO2), AB (ABO3)\], rhesus system \[RH1 (D), RH2 (C), RH3 (E), RH4 (c), RH5 (e)\], Kell system \[Kel1 (K)\], Kidd system \[JK1 (Jka), JK2 (Jkb)\] and Duffy system \[FY1 (Fya), FY2 (Fyb)\] determination which are classified as Class D.

Rationale

The application of this rule as defined above should be in accordance with the following rationale: A high individual risk, where an erroneous result would put the patient in an imminent life-threatening situation places the device into Class D.

The rule divides blood-grouping IVD medical devices into two subsets, Class C or D, depending on the nature of the blood group antigen the IVD medical device is designed to detect, and its importance in a transfusion setting.

Examples: HLA, Duffy system (other Duffy systems except those listed in the rule as Class D are in Class C). 

Rule 3: IVD medical devices to detect presence or exposure to sexually transmitted agents, infectious agents with limited propagation, or those used as pre-natal screening for immune status, screening for congenital disorders in foetuses, patient screening for selective therapy/diagnosis, staging of cancer, human genetic testing, used to monitor level of medicine, substances or biological components

IVD medical devices are classified as Class C if they are intended for use:

  • In detecting the presence of, or exposure to, a sexually transmitted agent (e.g. sexually transmitted diseases, such as chlamydia trachomatis, neisseria gonorrhoeae).
  • In detecting the presence in cerebrospinal fluid or blood of an infectious agent with a risk of limited propagation (e.g. neisseria meningitidis, cryptococcus neoformans).
  • In detecting the presence of an infectious agent where there is a significant risk that an erroneous result would cause death or severe disability to the individual or fetus being tested (e.g. diagnostic assay for CMV, chlamydia pneumoniae, Methycillin Resistant Staphylococcus aureus).
  • In pre-natal screening of women in order to determine their immune status towards transmissible agents (e.g. immune status tests for rubella or toxoplasmosis).
  • In determining infective disease status or immune status, and where there is a risk that an erroneous result will lead to a patient management decision resulting in an imminent life-threatening situation for the patient (e.g. enteroviruses, CMV and HSV in transplant patients).
  • In screening for selection of patients for selective therapy and management, or for disease staging, or in the diagnosis of cancer (e.g. personalised medicine).
    • Note: Those IVD medical devices where the therapy decision would usually be made only after further investigation (e.g. other IVD tests, markers) and those used for monitoring would fall into Class B under rule 6. Due consideration should be given to the clinical use of the test when determining the risk class.
  • In human genetic testing (e.g. Huntington’s disease, cystic fibrosis).
  • To monitor levels of medicines, substances or biological components, when there is a risk that an erroneous result will lead to a patient management decision resulting in an immediate life-threatening situation for the patient (e.g. cardiac markers, cyclosporin, prothrombin time testing).
  • In the management of patients suffering from a life-threatening infectious disease (e.g. HCV viral load, HIV Viral Load and HIV and HCV geno- and subtyping).
  • In screening for congenital disorders in the fetus (e.g. spina bifida or down syndrome).

Rationale

The application of this rule as defined above should be in accordance with the rationale for this rule which is as follows: IVD medical devices in this Class present a moderate public health risk, or a high individual risk, where an erroneous result would put the patient in an imminent life-threatening situation, or would have a major negative impact on outcome.

The IVD medical devices provide the critical, or sole, determinant for the correct diagnosis. They may also present a high individual risk because of the stress and anxiety resulting from the information and the nature of the possible follow-up measures. 

Rule 4: IVD medical devices for self-testing

IVD medical devices intended for self-testing are classified as Class C, except those devices from which the result is not determining a medically critical status, or is preliminary and requires follow-up with the appropriate laboratory test in which case they are Class B.

IVD medical devices intended for blood gases and blood glucose determinations for near-patient testing would be Class C. Other IVD medical devices that are intended for near patient should be classified in their own right using the classification rules.

Rationale

The application of this rule as defined above should be in accordance with the rationale for this rule which is as follows: In general, these IVD medical devices are used by individuals with no technical expertise and thus the labelling and instructions for use are critical to the proper outcome of the test.

  • Example for self-testing Class C: Blood glucose monitoring,
  • Example for self-testing Class B: Pregnancy self test, fertility testing, urine test strip.     

Rule 5: Reagents, other articles or standalone instruments used for in vitro diagnostic procedures, or specimen receptacles

The following IVD medical devices are classified as Class A:

  • Reagents or other articles that possess specific characteristics, intended by the product owner to make them suitable for in vitro diagnostic procedures related to a specific examination.
  • Standalone instruments (inclusive of software) intended by the product owner specifically to be used for in vitro diagnostic procedures, not intended for use in specific medical diagnostic purposes.
  • Specimen receptacles.

Note: Any product for general laboratory use not manufactured, sold or represented for use in specified IVD applications are not deemed to be IVD medical devices. These include:

  • Reagents.
  • Instruments.
  • Apparatus.
  • Equipment.
  • Systems that are intended for general laboratory applications and not intended by the product owner as medical devices. An example of general laboratory equipment would be an incubator.

Rationale

The application of this rule as defined above should be in accordance with the rationale for this rule which is as follows: These IVD medical devices present a low individual risk and no or minimal public health risk.

Examples: Sample-preparation instruments, wash solutions, plain urine cup.

Rule 6: IVD medical devices not covered in Rules 1 through 5 above

IVD medical devices not covered in Rules 1 through 5 are classified as Class B.

Rationale

The application of this rule as defined above should be in accordance with the rationale for this rule which is as follows: These IVD medical devices present a moderate individual risk as they are not likely to lead to an erroneous result that would cause death or severe disability, have a major negative impact on patient outcome or put the individual in immediate danger.

The IVD medical devices give results that are usually one of several determinants. If the test result is the sole determinant however other information is available, such as presenting signs and symptoms or other clinical information that may guide a physician, such that classification into Class B may be justified.

Other appropriate controls may also be in place to validate the results. This class also includes those IVD medical devices that present a low public health risk because they detect infectious agents that are not easily propagated in a population.

Note: For avoidance of doubt - IVD medical devices that are controls with a quantitative or qualitative assigned value will be covered under this rule.

Examples: Blood gases, H. pylori and physiological markers such as hormones, vitamins, enzymes, metabolic markers, specific IgE assays and celiac disease markers.

Rule 7: IVD medical devices that are controls without a quantitative or qualitative assigned value

IVD medical devices that are controls without a quantitative or qualitative assigned value will be classified as Class B.

Rationale

For such controls, the user, not the product owner, assigns the qualitative or quantitative value. 

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