技術電子報

歐盟MDR符合性評鑑程序

張貼者:2019年7月29日 上午12:28Yuhua Chen   [ 已更新 2019年9月2日 下午6:39 ]

歐盟MDR符合性評鑑程序與MDD符合性評鑑程序無太大差異,不同等級Class I (sterile, measurable, re-use), Class IIa, Class IIb, Class III可選擇符合性評鑑程序向驗證單位(Notified Body)提出申請,Class I不具滅菌、不具量測、不是重覆使用的產品,廠商只需自行MDR要求並提出自我宣告(Declaration of Conformity),不需向Notified Body申請

廠商確認產品等級後,依產品特性及可負擔之能力來撰擇符合性評鑑程序;另外,MDR符合性評鑑程序針對產品技術文件評鑑制定出抽樣方式如Class IIb至少每個器材類別項目(Generic Device Group)要有一個代表器材(Representative Device),而Class IIb植入物則必須每個器材都要看產品技術文件




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



醫療器材的人因/可用性工程

張貼者:2018年3月13日 上午2:46Yuhua Chen   [ 已更新 2018年3月13日 上午2:48 ]

因應ISO 13485改版,醫療器材在設計開發階段,製造商必須考量產品的可用性(Usability)作為設計開發的輸入,這裡參照的標準為IEC 62366-1。目前IEC 62366-1標準為2015版本,為IEC 62366:2007的改版,相對於IEC 62366:20072015版本加入了美國FDA人因工程(Human Factors Engineering)的想法。

那什麼是可用性(Usability)指的是建立有效性、效率、容易學習並讓使用者滿意的使用介面的特性; 而什麼是人因(Human Factors),是關於人的能力(身體、感官、情感與智力)與限制去設計開發工具、設備、系統、環境和組織的知識應用。一般而言,可用性與人因為相互使用的名詞,是為了讓使用者與醫療器材達到最佳化的關係,器材的使用介面讓使用者的失誤降至最低。

IEC 62366標準內說明醫療器材的可用性是與安全性有關,因此必須考慮到器材的風險管理,而執行可用性工程評估(Usability Engineering Evaluation)是以器材於正常使用狀態下使用錯誤,而不考慮非正常使用下的風險。該標準說明製造商應建立和文件化一個可用性工程過程提供使用者或相關人員等的安全,其中應建立使用規格(Use Specification),依ISO 14971鑑別出與安全有關以及潛在的使用錯誤的使用者介面特性,進而建立使用者介面規格(User Interface Specification)規劃使用者介面評估計劃,執行形成性評估(Formative Evaluation)和總結評估(Summative Evaluation)

另外,美國FDA2016年提出指引「應用人因和可用性工程於醫療器材」(Applying Human Factors and Usability Engineering to Medical Devices),說明人因確效測試(Human Factors Validation Test)是去證明該醫療器材的預期使用族群可以預期的使用環境下安全地與有效地執行預期使用的關鍵性任務,並於指引內提供人因工程報告的格式,供業界人士參考。

由於不適當使用醫療器材所引起的風險越來越多,可能因為這些醫療器材的使用介面不符合人性的直覺習慣,所以難於學習和使用,因此設計可用性好的醫療器材可降低該風險的產生,也等同減少了上市後因使用錯誤而進行設計修改和更新所付出的昂貴代價,並在設計開發過程中使用人因/可用性工程方法時,如果特別考慮到使用的視角,則可同時增加器材的整體易用性和吸引力,提供了產品競爭優勢。


如有醫療器材可用性評估需求,請與我們連繫。

淺談醫療器材軟體IEC 62304標準

張貼者:2018年3月8日 上午12:32Yuhua Chen   [ 已更新 2019年7月26日 上午2:26 ]

國際標準IEC 62304主要是針對醫療器材軟體所做的生命週期流程管理,適用範圍包括了純醫療軟體及嵌入或整合於醫療器材上的軟體。醫療器材製造商應提供和運行品質管理體制,來證實其有能力持續提供滿足顧客和適用法規要求的醫療器材軟體,即意謂醫療器材軟體符合IEC 62304標準外,必須架設在品質管理系統ISO 13485和風險管理系統ISO 14971之內

對於醫療器材軟體,其生命週期過程要包括:

  • 軟體發展過程
  • 軟體維護過程
  • 軟體風險管理過程
  • 軟體配置管理過程
  • 軟體問題解決過程

製造商應按照和軟體系統有關的危害對於患者、操作者或其他人員產生的影響,賦予每個軟體系統一個軟體安全性級別(A, B, C);如果軟體系統失效可能引起危害,則此項失效的機率應假定為100%。按照軟體失效效應的嚴重度,軟體安全等級分為:

  • A級:不可能有傷害
  • B級:不可能有重傷
  • C級:可能死亡或重傷

如果危害引起的風險,可透過硬體的風險控制措施使其降至可接受水準,則分級方案應將此項風險控制措施考慮在內。

IEC 62304 標準要求下列文件

  • 風險管理文件 Risk Management File/軟體安全分級 Software Safety Classification
  • 軟體開發計畫 Software Development Plan
  • 軟體系統需求 Software System Requirements
  • 軟體架構設計 Software Architectural Design
  • 軟體測試計畫 Software Test Plan
  • 可追溯性 Traceability Overview
  • 軟體測試報告 Software Test Report
  • 殘餘的異常 Residual Anomalies
  • 建構式管理 Configuration Management

在確認醫療器材軟體的安全性等級後,可依不同等級A, B, C有不同要求,去執行標準要求的過程、活動和工作進行軟體的設計開發、維護、風險管理、配置管理和問題解決。

醫療器材軟體只要符合IEC 62304標準,大致上已滿足了歐盟CE的軟體驗證要求,除非有其它特殊驗證需求,例如: 無線技術(Wireless Technology)


如有醫療器材軟體IEC 62304驗證需求,請與我們連繫。

 

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