Tıbbi Cihaz Sınıflandırma Kuralları

CLASSIFICATION RULES

PART I

DEFINITIONS SPECIFIC TO CLASSIFICATION RULES

1. DURATION OF USE

1.1. ‘Temporary’ means normally intended for continuous use for less than 60 minutes.

1.2. ‘Short-term’ means normally intended for continuous use for between 60 minutes and 30 days.

1.3. ‘Long-term’ means normally intended for continuous use for more than 30 days.

2. INVASIVE AND ACTIVE DEVICES

2.1. ‘Body opening’ means any natural opening in the body, including the external surface of the eye socket, or any permanent artificial opening such as a stoma.

2.2. ‘Surgical invasive device’:

(a) an invasive device that penetrates the body through a body surface, including through mucous membranes of body orifices, in the course of or as part of a surgical procedure; and

(b) a device that penetrates by a means other than through a body orifice.

2.3. ‘Reusable surgical instrument’ means an instrument intended for surgical use in cutting, piercing, sawing, scraping, abrading, clamping, retracting, clipping or similar procedures, without being connected to an active device, and designed by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilization have been carried out.

2.4. ‘Active therapeutic device’ means any active device used alone or in combination with other devices to support, replace, substitute or restore biological functions or structures for the treatment or alleviation of disease, injury or disability.

2.5. ‘Active diagnostic and monitoring device’ means any active device used alone or in combination with other devices to provide information to detect, diagnose, monitor or treat physiological conditions, health conditions, diseases or congenital disorders.

2.6. ‘Central circulatory system’ means the arteriae pulmonales, ascending aorta, arcus aortae, descending aorta up to bifurcation aortae, coronary arteries, common carotid arteries, externa carotid arteries, interna carotid arteries, cerebral arteries, brachiocephalic truncus, cordis venae, pulmonales, superior vena cava and inferior vena cava.

2.7. ‘Central nervous system’ means the brain, cerebrospinal fluid and spinal cord.

2.8. ‘Injured skin or injured mucous membrane’ means an area of ​​skin or mucous membrane that has undergone a pathological change or has been altered as a result of disease or injury.

SECTION II

APPLICATION RULES

3.1. The application of the classification rules is based on the intended use of the devices.

3.2. If the device in question is intended to be used in conjunction with another device, the classification rules apply to each device separately. Accessories of a medical device and a product listed in Annex XVI are classified in their own right, separate from the device with which they are used.

3.3. Software that operates or influences the use of a device is included in the same class as the device. If the software is independent of another device, it is classified on its own.

3.4. If the device is not intended to be used solely or primarily on a specific body part, the device is assessed and classified based on the most critical specified use.

3.5. If, based on the intended use of the device, several rules or sub-rules apply to the same device, the most stringent rule and sub-rule that gives the highest classification shall apply.

3.6. For the purposes of calculating the period referred to in Section 1, continuous use is:

(a) the entire period of use of the same device, regardless of whether the use is temporarily interrupted during a procedure or the device is temporarily taken out of service for purposes such as cleaning or disinfection. 61 Whether the interruption or out-of-service is temporary is determined in relation to the period of use before and after the period of interruption or out-of-service; and

(b) the total use of a device intended by the manufacturer to be promptly replaced by another device of the same type.

3.7. A device is considered to enable direct diagnosis when it provides the diagnosis of the disease or condition in question or provides decisive information for the diagnosis.

CHAPTER III

CLASSIFICATION RULES

4. NON-INVASIVE DEVICES

4.1. Rule 1

All non-invasive devices are classified as class I unless one of the following rules applies.

4.2. Rule 2

All non-invasive devices intended to transport or store blood, body fluids, cells or tissues, liquids or gases for eventual infusion, administration or delivery into the body:

- are classified as class IIa if they can be connected to a class IIa, class IIb or class III active device,

- are classified as class IIa if they can be connected to a class IIa, class IIb or class III active device,

- are classified as class IIa if they can be connected to a class IIb ... used to transport blood or other body fluids, except blood bags.

If intended for use in the transfer or storage of human tissues or cells, blood, other body fluids or other fluids, they are classified as class IIa. Blood bags are classified as class IIb.

In all other cases, such devices are classified as class I.

4.3. Rule 3

All non-invasive devices designed to alter the biological or chemical composition of human tissues or cells, blood, other body fluids or other fluids intended for implantation or administration into the body are classified as class IIb. However, if the process in which the device is used involves the filtration, centrifugation or exchange of gas or heat, such devices are classified as class IIa.

All non-invasive devices consisting of a substance or mixture of substances intended for in vitro use in direct contact with human cells, tissues or organs taken from the human body or for in vitro use with human embryos prior to implantation or administration into the body are classified as class III.

4.4. Rule 4

All non-invasive devices that come into direct contact with injured skin or injured mucous membranes shall be classified as:

- if they are intended to be used as a mechanical barrier for the suppression or absorption of secretions (exudates), class I;

- if they are intended primarily for skin injuries that have damaged the dermis or mucous membrane and can only promote healing as a secondary purpose, class IIb;

- if they are intended primarily to affect the microenvironment of injured skin or mucous membranes, class IIa;

- in all other cases, class IIa.

This rule also applies to invasive devices that come into contact with injured mucous membranes.

5. INVASIVE DEVICES

5.1. Rule 5

All invasive devices for body openings, other than surgically invasive devices, which are not intended to be connected to an active device or are intended to be connected to a class I active device, shall:

- be classified as class I if intended for temporary use;

- be classified as class IIa if intended for short-term use; however, those used in the oral cavity up to the pharynx, the ear canal up to the eardrum or the nasal cavity shall be classified as class I; and

- be classified as class IIb if intended for long-term use; however, those used in the oral cavity up to the pharynx, the ear canal up to the eardrum or the nasal cavity and those not likely to be absorbed by the mucous membrane shall be classified as class IIa.

All invasive devices for body openings, other than surgically invasive devices, which are intended to be connected to a class IIa, class IIb or class III active device shall be classified as class IIa.

5.2. Rule 6

All surgically invasive devices intended for temporary use shall be classified as class IIa. However, they shall be classified as class III if:

- they are specifically intended to control, diagnose, monitor or correct a disorder of the heart or central circulatory system, by direct contact with these parts of the body;

- they are reusable surgical instruments, they shall be classified as class I;

- they are specifically intended to be used in direct contact with the heart or central circulatory system or the central nervous system, they shall be classified as class III;

- they are intended to provide energy in the form of ionizing radiation, they shall be classified as class IIb;

- they have a biological effect or are completely or mostly absorbed, they shall be classified as class IIb;

- they are intended to administer medicinal products through a delivery system and such administration of a medicinal product is carried out in a manner that is potentially hazardous, taking into account the manner in which it is administered, they shall be classified as class IIb.

5.3 Rule 7

All surgically invasive devices intended for short-term use shall be classified as class IIa. However, they are:

- for the purpose of controlling, diagnosing, monitoring or correcting a disorder, particularly of the heart or central circulatory system, by direct contact with these parts of the body, classified as class III;

- for the purpose of using the device specifically for direct contact with the heart or central circulatory system or the central nervous system, classified as class III;

- for the purpose of providing energy in the form of ionising radiation, classified as class IIb;

- for having a biological effect or being absorbed in whole or in part, classified as class III;

- for causing chemical changes in the body, with the exception of devices for dental implants, classified as class IIb; or

- for the purpose of administering drugs, classified as class IIb.

5.4. Rule 8

All implantable devices and long-term surgically invasive devices are classified as class IIb. However, they are:

- for implantation into teeth, classified as class IIa;

- for delivering blood to the heart, central circulatory system,

if intended for use in direct contact with the central nervous system or the brain, it is classified as class III;

- if intended for use in direct contact with the brain, it is classified as class III;

- if intended for chemical change in the body, with the exception of devices placed on teeth, it is classified as class III;

- if intended for the administration of medical products, it is classified as class III.

- if intended for use in active implantable devices or accessories thereof, it is classified as class III;

- if intended for use in breast implants or surgical patches, it is classified as class III;

- if intended for use in total or partial joint replacement devices, with the exception of accessory components such as screws, wedges, plates and instruments, it is classified as class III; or

- if intended for use in spinal disc replacement implants or implantable devices in contact with the spine, with the exception of components such as screws, wedges, plates and instruments, it is classified as class III.

6. ACTIVE DEVICES

6.1. Rule 9

All active therapeutic devices intended to deliver or exchange energy shall be classified as class IIa; however, if the characteristics of such devices, the nature and intensity of the energy and the place of application are such that they are capable of delivering or exchanging energy with the human body in a potentially hazardous manner, they shall be classified as class IIb.

All active devices intended to control or monitor the performance of class IIb active therapeutic devices or intended to directly affect the performance of such devices shall be classified as class IIb.

All active devices intended to emit ionizing radiation for therapeutic purposes, including devices that control or monitor such devices or directly affect their performance, shall be classified as class IIb.

All active devices intended to control, monitor or directly affect the performance of active implantable devices shall be classified as class III.

6.2. Rule 10

Active devices for diagnostic and monitoring purposes are classified as class IIa:

- if they are intended to provide energy that will be absorbed by the human body, they are classified as class IIa; however, devices intended to illuminate the patient's body in a visible spectrum are classified as class I;

- if they are intended to visualize the in vivo distribution of radiopharmaceuticals, they are classified as class IIa;

- if they are intended to enable direct diagnosis or monitoring of vital physiological processes, they are classified as class IIa. However, if they are specifically intended to monitor vital physiological parameters and if variations in these parameters are of a nature that could result in immediate danger to the patient, such as variations in cardiac performance, respiration and central nervous system activity, or if they are intended for diagnosis in clinical situations where the patient is in immediate danger, they are classified as class IIb.

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

6.3. Rule 11

Software that provides information used to make diagnostic or therapeutic decisions is classified as class IIa. However, if such decisions:

- have an effect that is likely to cause death or irreversible deterioration of a person's state of health, such software is classified as class III;

- have an effect that is likely to cause serious deterioration of a person's state of health or surgical intervention, such software is classified as class IIb.

Software intended to monitor physiological processes is classified as class IIa. However, if the purpose is to monitor vital physiological parameters and variations in these parameters are likely to result in immediate danger to the patient, such software is classified as class IIb.

All other software is classified as class I.

6.4. Rule 12

All active devices intended to administer and/or remove medical products, body fluids or other substances from the body are classified as class IIa. However, if this process is carried out in a potentially hazardous manner, taking into account the nature of the substances involved, the body part concerned and the method of application, they are classified as class IIb.

6.5. Rule 13

All other active devices are classified as class I.

7. SPECIAL RULES

7.1. Rule 14

Devices that are considered to be medicinal products as defined in Article 1(2) of Directive 2001/83/EC when used separately, including a medicinal product derived from human blood or human plasma as defined in Article 1(10) of that Directive, and All devices that contain as an integral part a substance that aids in the function of the device shall be classified as class III.

7.2. Rule 15

All devices used for contraception or for the prevention of the transmission of sexually transmitted diseases shall be classified as class IIb. However, if they are implantable or long-term invasive devices, they shall be classified as class III.

7.3. Rule 16

All devices intended specifically for the disinfection, cleaning, rinsing or, where appropriate, moistening of contact lenses shall be classified as class IIb.

All devices intended specifically for the disinfection or sterilization of medical devices shall be classified as class IIa. However, if these devices are disinfecting solutions or washer disinfectants specifically intended for the disinfection of invasive devices as an end point of the procedure, they shall be classified as class IIb.

This rule does not apply to devices intended to clean devices, with the exception of contact lenses, by physical force alone.

7.4. Rule 17

Devices intended specifically to record diagnostic images produced by X-ray radiation shall be classified as class IIa.

7.5. Rule 18

All devices manufactured using tissues or cells of human or animal origin or their derivatives, except for devices manufactured using tissues or cells of animal origin or their derivatives, which are non-viable or rendered non-viable, and which are intended to come into contact with intact skin only, shall be classified as class III.

7.6. Rule 19

All devices comprising or consisting of nanomaterials:

- if they have a high or medium intrinsic exposure potential, they shall be classified as class III;

- if they have a low intrinsic exposure potential, they shall be classified as class IIb; and - if they have a negligible intrinsic exposure potential, they shall be classified as class IIa.

7.7. Rule 20

All invasive devices related to body orifices, with the exception of surgically invasive devices, intended to administer medicinal products by inhalation, shall be classified as class IIa. However, if the mechanism of action of these devices has a significant impact on the efficacy and safety of the administered medicinal product or if they are intended to treat life-threatening conditions, they shall be classified as class IIb.

7.8. Rule 21

Devices intended to be applied to the skin or to enter the human body via a body orifice and consisting of substances or combinations of substances that are absorbed by the human body or locally distributed in the human body:

- if, in order to achieve their intended purpose, these devices or the metabolism products of these devices are systemically absorbed by the human body, they shall be classified as class III;

- if, in order to achieve their intended purpose in the stomach or lower gastrointestinal tract, these devices or the metabolism products of these devices are systemically absorbed by the human body, they shall be classified as class III;

- if applied to the skin or in the nasal cavity or the oral cavity up to the pharynx and its intended use is in these cavities, it is classified as class IIa and

- in all other cases, it is classified as class IIb.