医疗器械分类规则 – Active devices

ACTIVE DEVICES

6.1. Rule 9

All active therapeutic devices intended to administer or exchange energy are classified as class IIa unless their characteristics are such that they may administer energy to or exchange energy with the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy, in which case they are classified as class IIb.

All active devices intended to control or monitor the performance of active therapeutic class IIb devices, or intended directly to influence the performance of such devices are classified as class IIb.

All active devices intended to emit ionizing radiation for therapeutic purposes, including devices which control or monitor such devices, or which directly influence their performance, are classified as class IIb.

All active devices that are intended for controlling, monitoring or directly influencing the performance of active implantable devices are classified as class III.

[Explains from the guidance MDCG 2021-24, General explanation of rules/practical/issues/examples]

Rule 9 – Active therapeutic devices intended to administer or exchange energy1, as well as active devices intended to control/monitor/directly influence certain devices.

This rule covers many different groups of devices, such as:

electrical equipment used in surgery such as lasers and surgical generators;

stimulation devices;

devices intended to emit ionizing radiation2 for therapeutic purposes, including devices which control or monitor such devices, or which directly influence their performance;

devices intended for controlling, monitoring or directly influencing the performance of active implantable devices.

Active implantable devices are covered by Rule 8.

Rule 22 may also apply to active therapeutic devices

[Rule 9 devices Examples]

Class IIa: All active therapeutic devices intended to administer or exchange energy are classified as class IIa:

– Electrical and/or magnetic and electromagnetic energy:

– muscle stimulators

– external bone growth stimulators

– TENS devices

– eye electromagnets

– electrical acupuncture

– Thermal energy:

– heat exchangers, except the types described below

– Mechanical energy:

– powered dermatomes

– powered drills

– dental hand pieces

– Light: phototherapy for skin treatment and for neonatal care

– Sound:

– external hearing aids

– Ultrasound:

– equipment for physiotherapy

– Sleep apnoea ventilators without monitoring function

Class IIb: unless their characteristics are such that they may administer energy to or exchange energy with the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy, in which case they are classified as class IIb.

– Kinetic energy:

– lung ventilators

– Thermal energy:

– incubators for babies

– blood warmers

– electrically powered heat exchangers (with patients incapable of reacting, communicating /or who are without a sense of feeling)

– Electrical energy:

– high-frequency electrosurgical generators, and electrocautery equipment, including their electrodes

– external pacemakers and external defibrillators with no integrated or incorporated diagnostic function

– electroconvulsive therapy equipment

– Coherent light:

– surgical lasers

– Ultrasound:

– lithotriptors, surgical ultrasound devices

– high-intensity focused ultrasound (HIFU)

Class IIb: All active devices intended to control or monitor the performance of active therapeutic class IIb devices, or intended directly to influence the performance of such devices are classified as class IIb.  External feedback systems for active therapeutic devices

Class IIb: All active devices intended to emit ionizing radiation for therapeutic purposes, including devices which control or monitor such devices, or which directly influence their performance, are classified as class IIb – Brachytherapy therapy devices if the device also generates the radiation

– Therapeutic cyclotrons and linear accelerators

– Therapeutic X-ray sources

Class III: All active devices that are intended for controlling, monitoring or directly influencing the performance of active implantable devices are classified as class III – Programming units and pacing system analysers:

– Cardioscopes with pacing pulse indicators specifically intended to monitor active implantable devices

– Programmer for:

– implantable Pulse Generator (IPG);

– implantable Cardioverter Defibrillator (ICD)

– implantable Loop Recorder

– Remote monitoring devices for active implantable devices

Note 1: The decision as to whether a medical device administers or exchanges energy to and from the human body in a potentially hazardous way should take into account the following factors. The concept of ‘potentially hazardous’ is dependent on the type of technology involved and the intended application of the device to the patient and not on the measures adopted by the manufacturer in view of good design management (e.g. use of technical standards, risk analysis). For instance, all devices intended to emit ionizing radiation, all lung ventilators and lithotriptors should be in Class IIb. However, the manufacturer’s obligation to comply with design requirements and solutions adopted, exist independently from the classification system. Devices for illumination, i.e. administration of rays in visible light spectrum, for use in the process of diagnosis are classified as class IIa or higher, e.g. visual electrophysiology or fundoscopes for examination of the eye; whereas devices for illumination for purposes other than in the process of diagnosis, e.g. therapeutic purposes (light therapy), are class I.

Note 2: ‘Ionising radiation’ means energy transferred in the form of particles or electromagnetic waves of a wavelength of 100 nanometres or less (a frequency of 3 × 1015 hertz or more) capable of producing ions directly or indirectly (Directive 2013/59/EURATOM, Article 4, 46).

6.2. Rule 10

Active devices intended for diagnosis and monitoring are classified as class IIa:

— if they are intended to supply energy which will be absorbed by the human body, except for devices intended to illuminate the patient’s body, in the visible spectrum, in which case they are classified as class I;

— if they are intended to image in vivo distribution of radiopharmaceuticals; or

— if they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless they are specifically intended for monitoring of vital physiological parameters and the nature of variations of those parameters is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of the central nervous system, or they are intended for diagnosis in clinical situations where the patient is in immediate danger, in which cases they are classified as class IIb.

Active devices intended to emit ionizing radiation and intended for diagnostic or therapeutic radiology, including interventional radiology devices and devices which control or monitor such devices, or which directly influence their performance, are classified as class IIb.

[Explains from the guidance MDCG 2021-24, General explanation of rules/practical/issues/examples]

Rule 10 – Active devices for diagnosis and monitoring or intended for diagnostic or therapeutic radiology

This rule covers a whole range equipment in various fields for capture of physiological signals, as well as specifically therapeutic and diagnostic radiology. Note that devices for recording diagnostic X-ray images are covered by Rule 17. Devices specifically intended to monitor active implantable devices fall under Rule 8 or Rule 9.

[Rule 10 devices Examples]

Class IIa: Active devices intended for diagnosis and monitoring are classified as class IIa:

– if they are intended to supply energy which will be absorbed by the human body,

– Magnetic resonance equipment

– Pulp testers

– Evoked response stimulators

– Diagnostic ultrasound

Class I:  except for devices intended to illuminate1 the patient’s body, in the visible spectrum, in which case they are classified as class I;

– Examination lamps

– Surgical microscopes intended to illuminate the patient’s body in the visible spectrum

– Dermatoscopes with integrated light sources

Class IIa:

– if they are intended to image in vivo distribution of radiopharmaceuticals; or

– Gamma cameras

– Positron emission tomography and single photon emission computer tomography

Class IIa:

– if they are intended to allow direct diagnosis or monitoring of vital physiological processes,

– Electrocardiographs

– Electroencephalographs

– Electronic thermometers

– Electronic stethoscopes

– Electronic blood pressure measuring equipment

Class IIb: unless they are specifically intended for monitoring of vital physiological parameters and the nature of variations of those parameters is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of the central nervous system, or they are intended for diagnosis in clinical situations where the patient is in immediate danger, in which cases they are classified as class IIb.

– Blood gas analysers used in open heart surgery

– Apnoea monitors, including apnoea monitors in home care

– Patient monitors (intended use: Monitor intended for multi-parameter patient monitoring. The device will produce visual and audible alarms if any of the physiological parameters monitored vary beyond pre-set limits and timed alarm recordings will be produced.), for example in intensive care monitoring, e.g. blood pressure, temperature, and oxygen saturation.

Class IIb: Active devices intended to emit ionizing radiation4 and intended for diagnostic or therapeutic radiology5, including interventional radiology devices5 and devices which control or monitor6 such devices, or which directly influence their performance, are classified as class IIb.

– Diagnostic X-Ray machine

– Computed Tomography Devices

Note 1: ‘Illuminate’ means: to administer rays in visible light spectrum to for use in the process of diagnosis for example in visual electrophysiology and eye diseases, and not just to cast a light to improve the visibility. When performing diagnosis to, for example, perform visual electrophysiology in search of eye diseases, the intended purpose of the device is not limited to ‘illumination’, but may include diagnosis.

Note 2: A device is considered to allow direct diagnosis when it itself provides the diagnosis of the disease or condition in question or when it provides decisive information for the diagnosis (MDR 2017/745, Annex VIII, 3.7). For the definition of diagnosis see the MDCG Guidance document covering the borderline between medical devices and medicinal products.

Note 3: Vital physiological processes and parameters include, for example, respiration, heart rate, cerebral functions, blood gases, blood pressure and body temperature. Medical devices intended to be used for continuous surveillance of vital physiological parameters in anesthesia, intensive care or emergency care are in class IIb, whilst medical devices intended to be used to obtain readings of vital physiological signals as part of routine checkups or self-monitoring are in class IIa. A thermal imaging device intended to monitor blood flow is not considered to be a body temperature measuring device.

Note 4: ‘Ionising radiation’ means energy transferred in the form of particles or electromagnetic waves of a wavelength of 100 nanometers or less (a frequency of 3 × 1015 hertz or more) capable of producing ions directly or indirectly (Directive 2013/59/EURATOM, Article 4, 46).

Note 5: Therapeutic interventional radiology refers to diagnosis being carried out during a surgical procedure.

Note 6: This refers to active devices for the control, monitoring or influencing the emission of ionizing radiation and not to the subsequent processing, recording or viewing of the resulting image. Devices for recording diagnostic X-ray images are covered by Rule 17.

6.3. Rule 11

Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:

— death or an irreversible deterioration of a person’s state of health, in which case it is in class III; or

— a serious deterioration of a person’s state of health or a surgical intervention, in which case it is classified as class IIb.

Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.

All other software is classified as class I.

[Explains from the guidance MDCG 2021-24, General explanation of rules/practical/issues/examples]

Rule 11 – Software intended to provide information to inform decisions with diagnosis or therapeutic purposes or software intended to monitor physiological processes.

Rule 11 describes and categorizes the risk of software based on the combination of the significance of the information provided by the software to the healthcare decision and the healthcare situation or patient’s condition.

This rule also distinguishes between MDSW (medical device software) intended to monitor vital and non-vital physiological processes (the sub- rule only applies to software intended for monitoring purposes only).

Software or equipment attached to devices which do not specifically enable device(s) to be used in accordance with their intended purpose, or to specifically or directly assist the medical functionality of the device in terms of its/their intended purpose do not meet the definition of an accessory.

Software used in conjunction with medical devices(s) which solely record, store or display information would generally not be considered devices (see guidance MDCG 2019-11, section 3.3 for further detail). For example, software analogous to diaries for recording insulin doses would not be considered devices, unless an analysis is performed on the data or the device in some way alters the patients treatment, prescription, doses etc.

[Rule 11 devices Examples]

Class IIa: Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:

– MDSW intended to rank therapeutic suggestions for a health care professional based on patient history, imaging test results, and patient characteristics, for example, MDSW that lists and ranks all available chemotherapy options for BRCA-positive individuals.

– Cognitive therapy MDSW where a specialist determines the necessary cognitive therapy based on the outcome provided by the MDSW.

Class III:

— death or an irreversible deterioration of a person’s state of health1, in which case it is in class III; or   MDSW intended to perform diagnosis by means of image analysis for making treatment decisions in patients with acute stroke.

Class IIb:

— a serious deterioration of a person’s state of health1 or a surgical intervention, in which case it is classified as class IIb. A mobile app intended to analyse a user’s heartbeat, detect abnormalities and inform a physician accordingly. MDSW intended for diagnosing depression based on a score resulting from inputted data on patient symptoms (e.g. anxiety, sleep patterns, stress etc.).

Class IIa: Software intended to monitor physiological processes is classified as class IIa,

– MDSW intended to monitor physiological processes that are not considered to be vital.

– Devices intended to be used to obtain readings of vital physiological signals in routine check-ups including monitoring at home.

Class IIb: except if it is intended for monitoring of vital physiological parameters3, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.   Medical devices including MDSW intended to be used for continuous surveillance of vital physiological processes in anaesthesia, intensive care or emergency care.

Class I:  All other software is classified as class I.  MDSW app intended to support conception by calculating the user’s fertility status based on a validated statistical algorithm. The user inputs health data including basal body temperature (BBT) and menstruation days to track and predict ovulation. The fertility status of the current day is reflected by one of three indicator lights: red (fertile), green (infertile) or yellow (learning phase/cycle fluctuation).

Note 1: The MDR contains several references to ‘serious deterioration of a person’s state of health’ and to ‘surgical intervention’, notably in the vigilance or clinical investigation context. Further horizontal guidance may be provided in the future and will be available at: https://ec.europa.eu/health/md_sector/new_regulations/guidance_en .

Note 2: For the classification of software, it is needed to consider the intended purpose, intended population (including e.g. diseases to be treated and/or diagnosed), context of use (e.g. intensive care, emergency care, home use) of the software and of the information provided by the software as well as of the possible decisions to be taken.

Note 3: Medical device software should be classified in the same way, regardless of the software’s location or the type of interconnection between the software and a (hardware) device. However, in line with implementing rule 3.3 Annex VIII to the MDR, software which drives a device or influences the use of a device shall fall within the same class as the device.

For further information on qualification and classification of software consult: MDCG 2019-11 Qualification and classification of software – Regulation (EU) 2017/745 and Regulation (EU) 2017/746

6.4. Rule 12

All active devices intended to administer and/or remove medicinal products, body liquids or other substances to or from the body are classified as class IIa, unless this is done in a manner that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application in which case they are classified as class IIb.

[Explains from the guidance MDCG 2021-24, General explanation of rules/practical/issues/examples]

Rule 12 – Active devices intended to administer and/or remove medicinal products, body liquids or other substances to or from the body

This rule is intended to primarily cover drug delivery systems and anaesthesia equipment. If the device’s intended route of drug delivery is pulmonary, Rule 20 applies.

[Rule 12 devices Examples]

Class IIa: All active devices intended to administer and/or remove medicinal products, body liquids or other substances to or from the body are classified as class IIa,

– Suction pump

– Feeding pumps

– Jet injectors for vaccination

– Elastomeric pumps or balloon pumps for infusion

Class IIb: unless this is done in a manner that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application in which case they are classified as class IIb.

– Infusion pumps

– Ventilators

– Anaesthesia machines

– Anaesthetic vaporisers

– Dialysis equipment

– Blood pumps for heart-lung machines

– Hyperbaric chambers

– Pressure regulators for medical gases

– Medical gas mixers

– Moisture exchangers in breathing circuits if used on unconscious or non-spontaneously breathing patients

– Oxygen concentrator used to deliver oxygen enriched air directly to the patient

6.5. Rule 13

All other active devices are classified as class I.

[Explains from the guidance MDCG 2021-24, General explanation of rules/practical/issues/examples]

Rule 13 – All other active devices

This is a fallback rule to cover all active devices not covered by other rules.

[Rule 13 devices Examples]

Class I:  All other active devices are classified as class I.

– Electric wheelchairs

– Dental curing lights

– Electric hospital beds

– Patient hoists

– Dental patient chairs