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歐盟醫療器材命名系統(EMDN)

張貼者:2020年3月25日 上午8:50Yuhua Chen   [ 已更新 2020年3月25日 下午9:47 ]

歐盟MDRIVDR要求製造商在醫療器材資料庫(EUDAMED)中註冊其醫療器材時,必須使用歐盟醫療器材命名系統(The European Medical Device Nomenclature, EMDN),而依歐盟委員會已於20201月發布公告決定使用Classificazione Nazionale Dispositivi medici (CND)作為未來EMDN的基礎。

CND2005年為義大利衛生部規定成為義大利官方的醫療器材分類及命名法,到現在來自各國家或地區約1.5萬家製造商使用CND在義大利資料庫中註冊了醫療器材及體外診斷醫療器材,製造商包括了31.6%來自義大利、15.2%來自美國、10.2%來自德國、9.8%來自中國大陸等地區。

EMDN採用CND作為醫療器材管理工具,因為它具有完善的層次結構,能使資訊以標準化方式進行溝通,用來支持改善病患安全及醫療系統的品質,CND目前不包括以下產品

n   藥品

n   化妝品

n   人類血液及其衍生物

n   人類器官、組織和細胞,包括人類組織和細胞的產品及其衍生產品

n   動物來源的器官、組織和細胞,但使用已失去活性的動物組織或衍生自動物組織失去活性產品所製造的醫療器材除外

n   個人保護裝置

CND是在多個層次中建立字母數字結構,它將醫療器材分為三個主軸,但最多13個字母數字代碼

n   類別(Category) - 由單個字母組成 (A-Z),即 Level 1

n   群組(Group) - 由兩個數字組成 (01-99),即 Level 2

n   類型(Type) - 由一系統列數字組成(其數量取決定詳細程度),兩兩(01-99)成一組,最多可到5組,即 Level 3, 4, 5, 6, 7

 A # # # # # # # # # #
Level 1                  Level 2                                  Level from 3 to 7
Categories           Groups                                  Types

目前
CND仍在進行調整,以便作為EMDN第一個版本發布,該版本未來會整合到EUDAMED中免費供使用者使用。

除了歐盟所發布指引外,更多CND資訊可參考Italian Ministry website (http://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=328&area=dispositivi-medici&menu=classificazione ),以協助公司建立EMDN的要求。


參考資訊

  1.  The EMDN – The nomenclature of use in EUDAMED
  2.  The CND nomenclature – Background and general principles

歐盟委員會延長部分Class I 器材的MDR過渡期

張貼者:2020年3月17日 下午8:20Yuhua Chen   [ 已更新 2020年3月17日 下午8:50 ]

依歐盟2019.12.27發布的歐盟醫療器材條例勘誤(Corrigenda to the European Union Medical Device Regulation),更正MDR120條第3款將部分Class I器材(:可重複使用的手術器材)93/42/EEC MDD轉換MDR過渡期延長4(2024.5.26)

為了符合這個條款,Class I器材必須滿足以下條件:

  1. 2020526日之前符合93/42/EEC 醫療器材指令(MDD)的符合性聲明
  2. 繼續滿足93/42/EEC指令的要求
  3. 產品設計無重大變化
  4. 產品預期用途無重大變化
  5. 2020.5.26後遵守MDR的上市後監督(PMS)、市場監督、警戒系統(Vigilance)、經濟營運商(Economic Operators)和器材註冊的要求替代93/42/EEC指令的相對應要求。

但請注意,從2020526日開始,器材註冊將受到歐洲醫療器材資料庫(EUDAMED)的影響,該資料庫延遲至2022526日。

歐盟MDR及IVDR對於OBL及OEM的衝擊

張貼者:2020年2月17日 下午11:14Yuhua Chen   [ 已更新 2020年2月17日 下午11:14 ]

何謂OBL,即Own Brand Labeler的縮寫,是指自然人或法人從OEM(Original Equipment Manufacturer)購買醫療器材成品,並放上自己商標販售該成品,並對該產品負有法律責任。

在之前歐盟MDD(93/42/EEC)IVDD(98/79/EC)規範下,OBL向公告機構NB(Notified Body)申請時使用OEMCE證書來證明產品符合歐洲醫療器材指引要求,除此之外,並提供簡化的技術文件檔案,所以OEM一定要有CE證書。OBL將使用OEMCE證書來獲得自己的產品CE證書。 然後,他們可以以自己的品牌銷售該產品,而無需向客戶提及該產品實際上是由OEM製造的。另外,唯一的條件是OBL不能修改OEM的產品,但OBL商標的標籤訊息是可以更動。

然而OBL在歐盟MDRIVDR的要求下,若要繼續持有CE證書,必須遵守MDRIVDR10"製造商的一般義務"(General obligations of manufacturers ),該條文包括了完整的技術文件檔案、品質管理系統(Quality Management System)、法規人員(Person Responsible for Regulatory Compliance)的責任及義務等。因此對於OBL來說,若要持有CE證書的情況下,需要從OEM拿到更多產品技術資料及生產資訊等機密資料並建立完整的品管理系統。

OEM廠商須重新思考與OBL合作模式,或許由OEM廠商作為製造商(Manufacturer)持有CE證書,在產品標籤上標明其名稱,而OBL作為經銷商(Distributor),也可以出現在標籤上。另一個方式,OEM成為OBL供應商,並將技術文件檔案的完全控制權授予OBLOBL成為產品的製造商,持有CE證書。

 

歐盟MDR及IVDR的上市後監督(Post-market surveillance, PMS)

張貼者:2020年2月3日 下午9:53Yuhua Chen   [ 已更新 2020年2月17日 下午11:01 ]

歐盟MDRIVDR對於上市後監督(Post-market surveillance, PMS)要求放在MDR Article 83-86IVDR Article 78-81,製造商必須依器材風險等級及種類去計畫、建立、維持和更新上市後監督(PMS)系統,該系統應主動和系統地收集、記錄和分析器材在其整個生命週期內的品質、效能和安全相關數據,以得到必要的結論並確定、實施和監測任何預防和矯正措施。

MDRIVDR對於不同等級風險器材的上市後監督(PMS)所制定規則有所不同,以下列出製造廠必須準備的文件

Documentation

MDR

IVDR

Post-market surveillance plan

(PMS plan)

Class I

Class IIa

Class IIb

Class III

Class A

Class B

Class C

Class D

Post-market surveillance report

(PMS report)

Class I

(Update report when necessary)

Class A

Class B

(Update report when necessary)

Periodic safety update report

(PSUR)

Class IIa 

(Update report at least every two years)

Class IIb

(Update report at least annually)

Class III

(Update report at least annually)

Class C

(Update report at least annually)

Class D

(Update report at least annually)

另外,請注意MDR中說明無論器材是否已符合MDR(只符合MDD情況下)都必須於2020526日起實施上市後監督(PMS)要求,即為MDR Article 83-86,因此建議若還沒開始申請MDR但仍必須提早確認公司品質系統或技術文件是否符合MDR上市後監督(PMS)要求。


ISO 13485架構下如何建立符合歐盟MDR和IVDR的品質管理系統QMS

張貼者:2020年1月14日 下午6:47Yuhua Chen   [ 已更新 2020年2月17日 下午11:00 ]

歐盟醫療器材法規(MDR)和體外診斷醫療器材法規(IVDR)對於製造商的品質管理系統(Quality Management System, QMS)要求包括在第10條第9(Article 10, 9)和第10條第8(Article 10, 8)。儘管大部分醫療器材製造商已取得了ISO 13485品質系統驗證,但不代表您的品質管理系統QMS已符合MDRIVDR10條的要求;除了第10條外,MDRIVDR也強調了一些特定的歐盟要求項目,為了使ISO 13485符合MDRIVDR,摘要重點如下:

  • 上市後監督系統(Post-market Surveillance System, PMS) - 上市後監督計畫(Post-market Surveillance Plan, PMS Plan)上市後監督報告(Post-market Surveillance Report, PMS Report)定期安全性更新報告(Periodic Safety Update Report, PSUR)等。
  • 警戒系統(Vigilance) - 嚴重事件(Serious Incidents)安全矯正通報 (Field Safety Corrective Actions, FSCA)趨勢報告(Trend Reporting)等。
  • 法規符合性(Regulatory Compliance) - 法規人員(Person responsible for regulatory compliance)歐盟醫療器材上市認證途徑(Conformity assessment procedures)等。
  • 臨床證據(Clinical Evidence) - MDR 臨床評估(Clinical Evaluation)IVDR 效能評估(Performance Evaluation)MDR 上市後臨床追踪(Post-market Clinical Follow-up, PMCF)IVDR上市後效能追踪 (Post-market Performance Follow-up, PMPF)等。
  • 歐盟經濟營運商(Economic Operators) - 製造商責任義務、授權代表(Authorised Representative)責任義務、進口商責任義務、經銷商責任義務等。
  • 醫療器材單一識別系統(Unique Device Identification System, UDI)及標示(Labeling) - UDI 產品識別(device identifier, DI)UDI 生產識別(production identifier, PI)Basic UDI-DI等。
  • 歐盟醫療器材資料庫(European database on medical devices, EUDAMED) - 醫療器材註冊製造商註冊授權代表註冊進口商註冊MDR 安全性與臨床效能評估摘要(Summary of safety and clinical performance, SSCP)IVDR 安全性與效能評估摘要(Summary of safety and performance, SSP)等。
  • 供應鍵(Supply chain)管理- 供應商和外包流程管理、供應鍵中器材識別和可追溯性過程、抱訴處理、安全矯正通報(FSCA)合作等。
  • 一般安全與性能要求(General Safety and Performance Requirements, GSPR) - 與產品有關的適用法規要求,由之前MDDIVDD的基本要求(Essential Requirements, ER)改為一般安全與性能要求 (General Safety and Performance Requirements, GSPR)

若公司已有ISO 13485AIMDMDDIVDD的管理架構,您可以先了解MDRIVDR中的關鍵變更並進行差異分析(Gap Analysis),有助於了解公司現在所處的狀況及需要遵守的方向。


歐盟醫療器材資料庫(EUDAMED)概述

張貼者:2020年1月13日 下午5:56Yuhua Chen   [ 已更新 2020年2月17日 下午11:01 ]

自從歐盟MDRIVDR公告後,其中歐盟決定建立一個資訊網絡來管理醫療器材資料,這個資訊網絡就是歐盟醫療器材資料庫European database on medical device (EUDAMED),原先的醫療器材資料庫(EUDAMED)20115月開始,是作為歐盟國家主管機關和歐盟委員會之間的訊息交流中心,並不對民眾開放,其成立目的是加強醫療器材在歐洲市場監督和透明度,而因應MDRIVDR要求改版後的醫療器材資料庫(EUDAMED)的重要目的則為:

1.        幫助民眾對於投放在市場上醫療器材、公告機構(Notified Body)發出的相應書及相關經濟營運商(Economic Operator)有充分的了解;

2.        在歐盟境內市場實現器材單一識別以促進器材可追溯性;

3.        幫助民眾充分了解臨床試驗情況,並要求臨床試驗申請者遵守MDR要求及相關義務;

4.        要求製造商遵守MDR要求及相關義務;

5.        使歐盟成員國和委員會的主管機關能夠在充分知情的基礎上執行與MDR有關任務,並加強彼此之間的合作。

醫療器材資料庫(EUDAMED)的使用模組包括:

1.        醫療器材的註冊電子系統;

2.        UDI數據庫;

3.        經濟營運商(Economic Operator)電子登記系統;

4.        臨床試驗電子系統;

5.        警戒和上市後監督電子系統;

6.        市場監督電子系統。

存放在前述的電子系統的資訊在規定的範圍內會讓公告機構(Notified Body)、經濟營運商(Economic Operator)、申請者及民眾可以取得。

目前歐盟委員說明只有在整個醫療器材資料庫(EUDAMED)及其不同模組都實現了全部功能並接受獨立審核之後,才能使醫療器材資料庫(EUDAMED)投入運行。 因此醫療器材資料庫(EUDAMED)的發布將在歐盟IVDR適用日期一起完成,即為20225;但歐盟MDR仍於2020526日起適用

雖然目前醫療器材資料庫(EUDAMED)延後兩年,但廠商仍需為此部分預作準備,當醫療器材資料庫(EUDAMED)可以上線時,可立即上傳資料不擔誤申請歐盟證書時程。

歐盟MDR及IVDR對法規人員的要求及職責

張貼者:2019年12月26日 上午12:56Yuhua Chen   [ 已更新 2020年2月17日 下午11:01 ]

歐盟MDRIVDR要求製造商在公司組織內必須至少一位人員負責法規符合性(Person responsible for regulatory compliance, PRRC)當然如果公司組織人數少於50人,營業額低於一千萬歐元,屬於微型和小型企業,PRRC不用是公司組織內人員,可為外部人員,但其任期必須為長期且具有持續性。

至於PRRC的資格為下列兩者之一:

  • 獲得相關歐盟會員國承認的法律,醫學,藥學,工程學或其他相關科學學科的大學學位或課程認可後授予文憑、證書或其他具有正式資格的證明,並且至少具有一年醫療器材的法規事務或品質管理系統的專業經驗;或
  • 有四年的專業經驗在與醫療器材相關的法規事務或品質管理系統方面。

但如果是客制化器材(custom-made devices)製造商的PRRC在不影響有關專業資格的國家規定的情況下,第一條的專業經驗則必須為兩年

另外,與醫療器材相關的法規事務或品質管理系統方面的專業經驗應與歐盟要求相關

PRRC所需負責的內容如下:

  • 在器材被放行前,根據製造器材的品質管理系統對器材的符合性進行適當的檢查
  • 制定並保持最新之技術文件(Technical Documentation)歐盟符合性聲明(EU Declaration of Conformity)
  • 遵守MDR Article 10 (10) IVDR Article 10(9)上市後監督義務
  • MDR Article 8788IVDR Article 8286系統化紀錄和報告嚴重事件(Serious Incidents)現場安全矯正措施(Field Safety Corrective Actions)
  • 確保用於試驗用器材應依MDR Annex XV2章第4.1節或IVDR Annex XIV4.1節發布聲明。

PRRC可以由多人擔任,但必須將各別的責任予以清楚載明。


歐盟MDR醫療器材認證流程

張貼者:2019年7月29日 上午12:28Yuhua Chen   [ 已更新 2020年2月17日 下午11:01 ]

歐盟MDR醫療器材認證流程(即符合性評鑑程序)MDD醫療器材認證流程無太大差異,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公告機構(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




歐盟醫療器材分類分級/MDR Classification Rules

張貼者:2019年7月22日 上午1:53Yuhua Chen   [ 已更新 2020年2月17日 下午11:01 ]

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



歐盟授權代表(EU Authorized Representative)

張貼者:2018年1月14日 下午11:14Yuhua Chen   [ 已更新 2020年2月18日 下午7:17 ]

       為了滿足歐盟市場內銷售產品之安全性及對於消費者保護等法律法規要求,在歐盟境外的製造商必須委任一個設立於歐盟境內或EFTA的歐盟授權代表,擔任在歐盟境內製造商與政府單位、監督機關及消費者間連絡之窗口,另外在事故發生時透過歐盟的授權代表執行報告、通告及相關召回等事宜的協助。

  除非製造商在當地成立子公司或分公司可直接擔任歐盟授權代表外,一般來說許多製造商會選擇在眾多的歐盟境內的經銷商選擇一個為歐盟的授權代表,但如果製造商擁有許多的經銷商時,作為授權代表的經銷商是否有足夠的能力與精力協助其他的經銷商與歐盟各國的聯繫溝通呢?且當經銷商成為製造商的歐盟授權代表時,意味著製造商必須將貼有CE標誌的產品技術文件提供給經銷商(即授權代表),製造商們必須承擔著未來當不與該經銷商合作時,當該經銷商成為製造商的競爭對手時,技術資料外洩的可能性。

  綜合上述的考量,製造商其實可以選擇一個專業的歐盟授權代表,既不參與銷售的行為且站在中立的立場替製造商保管技術文件,並能夠專心協助製造商處理歐盟境內有關的法律法規問題以及擔任連絡窗口。


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