Home 醫材法規歐盟醫材 基礎歐盟醫材MDR,看這篇就夠了!(4) – MDR的架構

基礎歐盟醫材MDR,看這篇就夠了!(4) – MDR的架構

by 愛姆斯

MDR法規架構:

100多條的MDR,有沒有覺得光想都頭大了呢?我們前面提到了MDR和MDD的差別,可以知道MDR的大改版,對各經營者(Economic operators)的要求絕對是只有多沒有少呢?那MDR到底有包含哪些要求呢?乍看之下,把一大堆法規同時塞在一起真的會一些混亂(豈是一些混亂),我們就先把法規做一個最基本的展開做一個簡單的介紹。了解整個MDR的結構後,就會對歐盟的醫材法有個比較清楚的掌握,至少對MDR大約包含了什麼,界線大約在哪有個基本的了解。
 
MDR的組成可以分成10章123條,另外還有17個附錄。
這十章分別代表了:

第I章(第1-4條):適用範圍和定義
第I章簡述:
第一章當然是告訴此法規適用的範圍在哪裡,MDR中所提及的各種定義像是醫材的定義,還有針對部份定義做調整的情形,最後第4條說明了法規的監管情形
 
第II章(第5-24條):     醫材投入市場、 各經營體職責、再處理(reprocessing)、CE標誌、 產品自由流通
第II章簡述:
第二章算是一個比較混亂的章節,有點像是把看起來不那麼相關的一些主題拼起來。這章在說明產品要投放到市場上需要符合預期用途、GSPR中臨床評價等要求。另外一些像遠距銷售、宣稱、通用標準、各經營體(像是歐盟代表、製造商等)職責、產品再處理、DoC、CE標誌的議題也是放在這裡
 
第III章(第25-34條):    產品追溯、經營者註冊醫材、安全性與臨床性能摘要SSCP、歐盟醫材資料庫(EUDAMED)
第III章簡述:
從供應鏈管理、醫材的命名、UDI、SSCP、產品註冊到醫材資料庫EUDAMED,本章說明了歐盟追蹤產品的決心。
 
第IV章(第35-50條):    第三方驗證機構
第IV章簡述:
相較於MDD,Notified 只有放在第16條(大約一1-2頁),MDR一口氣塞給了NB 16條,把NB送上天堂。更清楚的定義了許多對NB的要求。這也是為什麼說MDR使得NB責任及負擔更大。
 
第V章(第51-60條):     醫材分類、符合性評鑑
第V章簡述:
更新的醫材分類和符合性評鑑搭配附錄VIII到附錄XI一起。需要重新檢視自家產品的分類和符合性評鑑是否在MDR下有改變。
 
第VI章(第61-82條):    臨床評估和試驗
第VI章簡述:
臨床絕對是MDR的重點部份。MDR將更多的臨床要求納入,比起MDD廠商極有可能要做更多的評估及報告甚至是試驗。
 
第VII章(第83-100條):  上市監管、警戒和市場監管
第VII章簡述:
上市後的監督也絕對少不了。更多重要的上市後要求也在MDR的第VII開始明確要求。細節在未來討論。
 
第VIII章(第101-108條): 歐盟成員國合作、 醫療器材協調小組(Medical Device Coordination Group, MDCG)、專家小組、醫材註冊資料庫等
第VIII章簡述:
本章著重在歐盟成員國及各種專家小組的規定
 
第IX章(第109-113條):    保密性、資料保護、資助及懲罰
第IX章簡述:
保密性、資料保護、資助及懲罰相關
 
第X章(第114-123條):      最終條例
第X章簡述:
一些其他相關規定
必須要先掌握它的結構才能知道它在談什麼、在規範什麼、在要求什麼。
下面我們簡要的將各章節提一下,大家就會有一個印象MDR涵蓋了哪些部份,也因此可以判斷像是定義加適用範圍、經營體職責、UDI和EUDAMED、臨床、上市後、更新的產品分類及符合性評鑑、GSPR、技術文件這些是相對重要,所以理解它們的內容尤其關鍵。在未來章節,我們會更進一步提供這些MDR重要的章節資訊。
下面是將MDR展開以章節區分MDR的組成要素,理解了章節組成,對閱讀法規有實質幫助。
(article)
主題
涵蓋部份
 I
 1-4
適用範圍和定義
第I章簡述:
第一章當然是告訴此法規適用的範圍在哪裡,MDR中所提及的各種定義像是醫材的定義,還有針對部份定義做調整的情形,最後第4條說明了法規的監管情形
1 Subject matter and scope
2 Definition
3 Amendment of certain definitions
4 Regulatory status of products
II 
 5-24
醫材投入市場、
各經營體職責、
再處理(reprocessing),
CE標誌、
產品自由流通
第II章簡述:
第二章算是一個比較混亂的章節,有點像是把看起來不那麼相關的一些主題拼起來。這章在說明產品要投放到市場上需要符合預期用途、GSPR中臨床評價等要求。另外一些像遠距銷售、宣稱、通用標準、各經營體(像是歐盟代表、製造商等)職責、產品再處理、DoC、CE標誌的議題也是放在這裡
 
5 Placing on the market and putting into service
6 Distance sales
7 Claims
8 Use of harmonised standards
9 Common specifications
10 General obligations of manufacturers
11 Authorised representative
12 Change of authorised representative
13 General obligations of importers
14 General obligations of distributors
15 Person responsible for regulatory compliance
16 Cases in which obligations of manufacturers apply to importers, distributors or other persons
17 Single-use devices and their reprocessing
18 Implant card and information to be supplied to the patient with an implanted device
19 EU declaration of conformity
20 CE marking of conformity
21 Devices for special purposes
22 Systems and procedure packs
23 Parts and components
24 Free movement
 III
 25-34
產品追溯、經營者註冊醫材、
安全性與臨床性能摘要SSCP、
歐盟醫材資料庫EUDAMED
第III章簡述:
從供應鏈管理、醫材的命名、UDI、SSCP、產品註冊到醫材資料庫EUDAMED,本章說明了歐盟追蹤產品的決心。
25 Identification within the supply chain
26 Medical devices nomenclature
27 Unique Device Identification [UDI] system
28 UDI database
29 Registration of devices
30 Electronic system for registration of economic operators
31 Registration of manufacturers, authorised representatives and importers
32 Summary of safety and clinical performance
33 European database on medical devices
34 Functionality of Eudamed
 IV
 35-50
第三方驗證機構
第IV章簡述:
相較於MDD,Notified 只有放在第16條(大約一1-2頁),MDR一口氣塞給了NB 16條,把NB送上天堂。更清楚的定義了許多對NB的要求。這也是為什麼說MDR使得NB責任及負擔更大。
35 Authorities responsible for notified bodies
36 Requirements relating to notified bodies
37 Subsidiaries and subcontracting
38 Application by conformity assessment bodies for designation
39 Assessment of the application
40 Nomination of experts for joint assessment of applications for notification
41 Language requirements
42 Designation and notification procedure
43 Identification number and list of notified bodies
44 Monitoring and re-assessment of notified bodies
45 Review of notified body assessment of technical documentation and clinical evaluation documentation
46 Changes to designations and notifications
47 Challenge to the competence of notified bodies
48 Peer review and exchange of experience between authorities responsible for notified bodies
49 Coordination of notified bodies
50 List of standard fees
 V
 51-60
醫材分類、
符合性評鑑
第V章簡述:
更新的醫材分類和符合性評鑑搭配附錄VIII到附錄XI一起。需要重新檢視自家產品的分類和符合性評鑑是否在MDR下有改變。
 
51醫材分類
符合性評鑑
52 Conformity assessment procedures
53 Involvement of notified bodies in conformity assessment procedures
54 Clinical evaluation consultation procedure for certain class III and class IIb devices
55 Mechanism for scrutiny of conformity assessments of certain class III and class IIb devices
56 Certificates of conformity
57 Electronic system on notified bodies and on certificates of conformity
58 Voluntary change of notified body
59 Derogation from the conformity assessment procedures
60 Certificate of free sale
 VI
 61-82
臨床評估和試驗
第VI章簡述
臨床絕對是MDR的重點部份。MDR將更多的臨床要求納入,比起MDD廠商極有可能要做更多的評估及報告甚至是試驗。
 
61 Clinical evaluation
62 General requirements regarding clinical investigations conducted to demonstrate conformity of devices
63 Informed consent
64 Clinical investigations on incapacitated subjects
65 Clinical investigations on minors
66 Clinical investigations on pregnant or breastfeeding women
67 Additional national measures
68 Clinical investigations in emergency situations
69 Damage compensation
70 Application for clinical investigations
71 Assessment by Member States
72 Conduct of a clinical investigation
73 Electronic system on clinical investigations
74 Clinical investigations regarding devices bearing the CE marking
75 Substantial modifications to clinical investigations
76 Corrective measures to be taken by Member States and information exchange between Member States
77 Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination
78 Coordinated assessment procedure for clinical investigations
79 Review of coordinated assessment procedure
80 Recording and reporting of adverse events that occur during clinical investigations
81 Implementing acts
82 Requirements regarding other clinical investigations
 VII
83-100
上市後監管、
警戒和市場監管
第VII章簡述
上市後的監督也絕對少不了。更多重要的上市後要求也在MDR的第VII開始明確要求。細節在未來討論。
 
第一部份POST-MARKET SURVEILLANCE
83 Post-market surveillance system of the manufacturer
84 Post-market surveillance plan
85 Post-market surveillance report
86 Periodic safety update report [PSUR]
第二部份VIGILANCE
87 Reporting of serious incidents and field safety corrective actions
88 Trend reporting
89 Analysis of serious incidents and field safety corrective actions
90 Analysis of vigilance data
91 Implementing acts
92 Electronic system on vigilance and on post-market surveillance
第三部份MARKET SURVEILLANCE
93 Market surveillance activities
94 Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance
95 Procedure for dealing with devices presenting an unacceptable risk to health and safety
96 Procedure for evaluating national measures at Union level
97 Other non-compliance
98 Preventive health protection measures
99 Good administrative practice
100 Electronic system on market surveillance
 VIII
 101-108
歐盟成員國合作,
醫療器材協調小組(Medical Device Coordination Group, MDCG),
專家小組
醫材註冊資料庫等
第VIII章簡述
本章著重在歐盟成員國及各種專家小組的規定
101 Competent authorities
102 Cooperation
103 Medical Device Coordination Group [MDCG]
104 Support by the Commission
105 Tasks of the MDCG
106 Provision of scientific, technical and clinical opinions and advice
107 Conflict of interests
108 Device registers and data banks
 IX
 109-113
保密性、
資料保護、
資助及懲罰
第IX章簡述
保密性、資料保護、資助及懲罰相關
109 Confidentiality
110 Data protection
111 Levying of fees
112 Funding of activities related to designation and monitoring of notified bodies
113 Penalties
X
114-123
 最終條例
第X章簡述
一些其他相關規定
114 Committee procedure
115 Exercise of the delegation
116 Separate delegated acts for different
117 delegated powers
118 Amendments to Regulation (EC) No 178/2002 [food]
119 Amendments to Regulation (EC) No 1223/2009 [cosmetic products]
120 Transitional provisions
121 Evaluation
122 Repeal
123 Entry into force and date of application

附錄

附錄部份幾乎都是絕對重要,未來將分別討論相關章節。
附錄
主題
 I
一般安全及性能要求
General safety and performance requirements
II 
技術文件
 III
技術文件(上市後監管部份)
 IV
歐盟符合性聲明
 V
CE標誌
CE marking of conformity
 VI
經營者及醫材註冊以及UDI
 VII
第三方驗證機構需要滿足的要求
Requirements to be met by notified bodies
 VIII
醫材分類規則
 IX
符合性評鑑-QMS+技術文件
Conformity assessment based on a quality management system and on assessment of technical documentation
X
符合性評鑑-型式檢查
based on type-examination
XI
符合性評鑑-產品驗證
Conformity assessment based on product conformity verification
XII
NB核發證書
XIII
客製化醫材流程
XIV
臨床評估和上市後臨床PMCF
Clinical evaluation and post-market clinical follow-up
XV
臨床試驗
XVI
不具醫療目的但需要MDR的產品
XVII
MDD、IVDD、MDR對照表
Correlation table showing Council Directive 90/385/EEC, Council Directive 93/42/EEC and the MDR

延伸閱讀:

基礎歐盟醫材MDR,看這篇就夠了!(1) – 什麼是MDR?
基礎歐盟醫材MDR,看這篇就夠了!(2) – 重要時間表
基礎歐盟醫材MDR,看這篇就夠了!(3) – MDR和MDD有什麼不一樣?

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