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歐盟醫療器材法規分類分級/MDR Classification Rules

張貼者:2019年7月22日 上午1:53Yuhua Chen   [ 已更新 2019年9月2日 下午6:42 ]
歐盟MDR針對醫療器材分類分級由原先MDD所規範的18個變成22,其中將使用奈米材料醫材、純軟體醫材等納入MDR規範,而原先因MDD未納入的乳房植入物(2003/12/EC)、關節植入物(2005/50/EC)及採用動物組織醫材(2003/32/EC)則全整合至MDR,該相關的指令2003/12/EC2005/50/EC2003/32/EC即廢止,下表彙整MDR Annex VIII Classification Rules 1-22

舉例說明:
Contact Lens 隱形眼鏡
Special rules - No
Active devices - No
Invasive devices - Yes,非手術使用,Rule 5,Class IIa or IIb 依據產品宣稱的接觸時間長短而定 

 Subjects
Non-invasive device – Rules 1, 2, 3, 4

Invasive devices – Rule 5, 6, 7, 8

Active devices – Rule 9, 10, 11, 12, 13

Special rules – Rule 14, 15, 16, 17, 18, 19, 20, 21, 22

 Non Invasive Devices Classification
 Rule 1 
 Devices that either do not touch patient or contact only intact skin I
 Rule 2 
Channelling or storing blood, body liquids, cells or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body 
 - If they may be connected to a class IIa, class IIb or class III active device IIa
 - If they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts of organs or body cells and tissues IIa
 The devices are intended for use for blood bags. IIb
 In all other cases I
 Rule 3 
Modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body IIb
 - Unless the treatment for which the device is used consists of filtration, centrifugation or exchanges of gas, heat IIa
The devices consisting of a substance or a mixture of substances intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body or used in vitro with human embryos before their implantation or administration into the body III
 Rule 4 
 In contact with injured skin or mucous membrane 
- If they are intended to be used as a mechanical barrier, for compression or for absorption of exudates I
- If they are intended to be used principally for injuries to skin which have breached the dermis or mucous membrane and can only heal by secondary intent IIb
- If they are principally intended to manage the micro-environment of injured skin or mucous membrane IIa
- In all other cases IIa
 This rule applies also to the invasive devices that come into contact with injured mucous membrane. 

 Invasive Devices Classification
 Rule 5
Invasive in body orifice or stoma (Not Surgically)
 
All invasive devices with respect to body orifices, other than surgically invasive devices, which are not intended for connection to an active device or which are intended for connection to a class I active device I
- If they are intended for transient use I
- If they are intended for short-term use IIa
- Except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity
 I
- If they are intended for long-term use IIb
- Except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity and are not liable to be absorbed by the mucous membrane
 IIa
 All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to a class IIa, class IIb or class III active device IIa
 Rule 6
Surgically invasive devices for transient use (< 60 minutes)
 
 All surgically invasive devices intended for transient use IIa
- Unless they are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body III
- Unless they are reusable surgical instruments I
- Unless they are intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system III
- Unless they are intended to supply energy in the form of ionising radiation IIb
- Unless they have a biological effect or are wholly or mainly absorbed IIb
- Unless they are intended to administer medicinal products by means of a delivery system, if such administration of a medicinal product is done in a manner that is potentially hazardous taking account of the mode of application IIb
Rule 7
Surgically invasive devices for short-term use (>60 minutes, <30 days)
 
All surgically invasive devices intended for short-term use IIa
-  Unless they are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body III
- Unless they are intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system III
- Unless they are intended to supply energy in the form of ionizing radiation IIb
- Unless they have a biological effect or are wholly or mainly absorbed III
- Unless they are intended to undergo chemical change in the body, except if the devices are placed in the teeth; or are intended to administer medicines IIb
 Rule 8
Implantable devices and long-term surgically invasive devices (> 30 days)
 
All implantable devices and long-term surgically invasive devices IIb
- Unless they are intended to be placed in the teeth IIa
- Unless they are intended to be used in direct contact with the heart, the central circulatory system or the central nervous system  III
- Unless they have a biological effect or are wholly or mainly absorbed III
- Unless they are intended to undergo chemical change in the body, except if the devices are placed in the teeth III
- Unless they are intended to administer medicinal products III
Unless they are active implantable devices or their accessories III
Unless they are breast implants or surgical meshes III
Unless they are total or partial joint replacements, with the exception of ancillary components such as screws, wedges, plates and instruments  III
Unless they are spinal disc replacement implants or are implantable devices that come into contact with the spinal column, with the exception of components such as screws, wedges, plates and instruments III

 Active Devices Classification
 Rule 9 
All active therapeutic devices intended to administer or exchange energy 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 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 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  IIb
All active devices that are intended for controlling, monitoring or directly influencing the performance of active implantable devices  III
 Rule 10 
Active devices intended for diagnosis and monitoring
-  
If they are intended to supply energy which will be absorbed by the human body
- If they are intended to image in vivo distribution of radiopharmaceuticals
- If they are intended to allow direct diagnosis or monitoring of vital physiological processes
 IIa
Active devices intended to illuminate the patient's body, in the visible spectrum I
Active devices 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  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  IIb
 Rule 11 (NEW) 
Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes  IIa
- Except if such decisions have an impact that may cause death or an irreversible deterioration of a person's state of health  III
- Except if such decisions have an impact that may cause a serious deterioration of a person's state of health or a surgical intervention IIb
Software intended to monitor physiological processes  IIa
-  Expect 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 patientIIb 
All other software
 Rule 12 
All active devices intended to administer and/or remove medicinal products, body liquids or other substances to or from the body  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 IIb
 Rule 13 
 All other active devices I

 Special Rules Classification
 Rule 14 
All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma, as defined in point 10 of Article 1 of that Directive, and that has an action ancillary to that of the devices III
 Rule 15 
All devices used for contraception or prevention of the transmission of sexually transmitted diseases IIb
- Unless they are implantable or long term invasive devices III
 Rule 16 
All devices intended specifically to be used for disinfecting, cleaning, rinsing or, where appropriate, hydrating contact lenses  IIb
All devices intended specifically to be used for disinfecting or sterilising medical devices  IIa
-  Unless they are disinfecting solutions or washer-disinfectors intended specifically to be used for disinfecting invasive devices, as the end point of processing IIb
This rule does not apply to devices that are intended to clean devices other than contact lenses by means of physical action only.  
 Rule 17 
Devices specifically intended for recording of diagnostic images generated by X-ray radiation  IIa
 Rule 18 
 All devices manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are non- viable or rendered non-viable, unless such devices are manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or rendered non-viable and are devices intended to come into contact with intact skin only III
 Rule 19 (New) 
 All devices incorporating or consisting of nanomaterial 
-  If they present a high or medium potential for internal exposure III
-  If they present a low potential for internal exposure IIb
-  If they present a negligible potential for internal exposure IIa
 Rule 20 (New) 
All invasive devices with respect to body orifices, other than surgically invasive devices, which are intended to administer medicinal products by inhalation IIa
-  Unless their mode of action has an essential impact on the efficacy and safety of the administered medicinal product or they are intended to treat life- threatening conditions IIb
 Rule 21 (New) 
Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body III
-  If they, or their products of metabolism, are systemically absorbed by the human body in order to achieve the intended purpose III
-  If they achieve their intended purpose in the stomach or lower gastrointestinal tract and they, or their products of metabolism, are systemically absorbed by the human body IIa
-  If they are applied to the skin or if they are applied in the nasal or oral cavity as far as the pharynx, and achieve their intended purpose on those cavities IIb
-  All other cases 
 Rule 22 (New) 
Active therapeutic devices with an integrated or incorporated diagnostic function which significantly determines the patient management by the device, such as closed loop systems or automated external defibrillators III



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