@Adopted from Nealda Leila M Yusof, Ph.D.
Regulatory Scientist, Centre for Medical Device Regulation Health Sciences Authority
adopting CENELEC HD 395-1), The syringe is an example of the EU legal inconsistencies at the time work began on the medical device directives. In some Member States syringes were regulated as drugs, in another a medical device law governed them if sold as sterile, and in others they were subject to no regulations at all. Remarks by Norbert Anselmann, European Comm'n, The Forthcoming EC Legislation on Medical Devices: Provisional Results and Outlook 5-6, at the Reg. Aff. Professionals Soc'y Conference on International Harmonization of Medical Device Regulation (June 22-23, 1992), at 5-6.
68 Council Decision 90/683: "The essential objective of a conformity assessment procedure is to enable the public authorities to ensure that products placed on the market conform to the requirements as expressed in the provisions of the directives, in particular with regard to the health and safety of users and consumers."
69 Council Directive 93/42/EEC, Art. 2.
70 E. Jongen, The Creation of an Internal Market For Industrial Goods in Europe Through Technical Harmonization, Standardization, Certification And Mutual Recognition (Jan. 1991).
71 Statement by Jacques MacMillan, European Comm'n, at U.S.-EU negotiations on Mutual Recognition Agreements (Apr. 1995).
Higher
Lower
Device Class
I IIa IIb III
General List B &
self-testing
List A
歐盟對於醫療器材的現行規範有
72
：(1) Active Implantable Medical Device Directive 90/385/EEC (AIMMD)
73
：主動植入式醫療器材指令。(2) The Medical Device Directive 93/42/EEC (MDD)
74
：一般醫療器材 指令。(3) In Diagnostic Device Directive 98/79/EC (IVDD)
75
：體外診斷器材 指令。其中涉及歐盟醫療器材的主要規範又集中於MDD，其管制範圍涵蓋歐盟主 要的醫療器材規範；同時EU 亦根據 AIMMD、MDD、IVDD 訂定許多參考標準
76
。歐盟將醫療器材分為三大類：
(1) 主動植入式醫療器材(active implantable medical device)：經由手術 或醫療方法，全部或部份植入人體或插入並留置於人體孔道之主 動裝置，所謂主動裝置是指藉電力或其他能源而達成其功能者。
這類器材是歐盟最早公佈管理的醫療器材(90/385/EEC)。
(2) 一般醫療器材(medical device): 供人類使用於以下用途之儀器、
設備、用品、材料或其他除主動植入式醫療器材以外之物品：診 斷、預防、追蹤、治療或減輕疾病；診斷、追蹤、治療或修整傷 處或殘障部位；解剖或生理過程之檢查、置換或修正；生育控制。
但不可藉藥性、免疫力或新陳代謝的方法在人體內達到其主要目 的，但輔助前述功能之物品仍屬醫療器材。這項指令稱為Medical Device Directive(93/42/EEC)，是最重要的醫療器材管理規定。
(3) 體外檢驗器材(in vitro diagnostic device)：任何自成單位或由其他 物件組成之任何試劑、試劑品、校正器、套組、控制物質、儀器、
設備或系統形式之裝置，製造商設計用以檢查人體組織標本(含血 液、組織切片等)之裝置，或用於以上目的之容器亦屬之。體外檢 驗試劑的指令原本預定於1996 年公佈，但因各國尚未達成共識，
所以未能公佈，目前的指令編號是COM(95)130。
歐盟的醫療器材指令包含了絕大多數的醫療器材，以下簡單地說明其分
72 EU guidelines: http://www.mdc-ce.de/stand_02.htm
73 See http://www.mdss.com/AIMDD/aimdd_directive.htm
74 http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=en&numdo
=31993L0042&model=guichett
75 http://www.mdc-ce.de/downloads/Ivd_d_en.pdf
76 http://www.mdc-ce.de/downloads/harm_st1.pdf
級原則。根據指令的附件九，醫療器材依據其風險程度可以分成四級。以下 淺介其分級制度(Midical Device Classification)：
A.分級制度：
I. EU Class I Device
77
這類器材在風險控管上層次最低，只要該醫療器材符合廠商對該器 材的宣稱即可上市
78
，而不需要Auditing Notified Body (NB)的介入審 查，但仍須提交警惕報告(Vigilance Reporting)。II. EU Class IIa Device
79
相較於美國的分級制度，歐洲將第二級細分成IIa、IIb，主要是針對 中 度 危 險 度 的 醫 療 器 材 ， 二 者 相 同 之 處 在 於 NB 仍 會 依 EN ISO9001、EN 46001 及 MDD 所訂之標準進行審查，同時並參照醫療 器材的技術報告(Technical File)；而主要的差異在於技術報告的內容 就IIa 與 IIb 分類中對於臨床實驗的要求高低
80
。在IIa 中對於技術報 告中的臨床證據要求，廠商可以以臨床報告或醫學文獻作為內容。III. EU Class IIb Device
中度風險、所有植入式或長期使用之手術侵入裝置。Class IIa 及 Class IIb 的器材均需經由歐盟指定機構(Notified Body)驗證通過，才可以 貼上CE Mark。相對於 IIa，更重視臨床實驗。
III. EU Class III Device
Class IIb 與 Class III 主要是針對醫療器材的品質控制，特別是著重設 計與生產的過程。此外，Class III 的醫療器材尚須經過製造廠商的臨 床 評 估(clinical evalution) ， 且 該 醫 療 器 材 於 上 市 前 須 符 合 通 過 Notified body 訂定的標準審查
81
。因此，雖然歐盟對於醫療器材的分級管理制度主要如同美國的醫療分級 制度
82
，然歐盟因不同的要求標準更將Class II 細分成 Class IIa 及 Class IIb，因而實質上，歐盟對於醫療器材的分級標準應為四級。
77 The Annex VII of the MDD is required in this part.
78 Special provisions govern Class I devices that have additional attributes, such as sterility or a measurement function.
79 MDD Annex II.3.
80 The evidence can be derived from clinical study, literature, competitors, etc.
81 European Commission Proposal for a Council Directive concerning medical devices (COM(91) 287 final-SYN 353) 4. A manufacturer of a Class III device avoids repetition of the same clinical
investigations in more than one member state. Note that all devices, not just Class III devices, need clinical evidence.
82 In the United States, Class I consists of devices for which general controls, applicable to devices
在歐盟的分級管理制度下，製造商須自行選擇將醫療器材歸入那一級的
generally, are deemed to be adequate. 21 U.S.C. §360c(a)(1)(A). General controls include authority to act against adulterated or misbranded devices, banning, registration and device listing, premarket notification (unless exempted), reporting, and compliance with good manufacturing practices. General controls apply to devices in all three classes. Class II devices are those needing some form of special controls, such as performance standards, postmarket surveillance, patient registries, guidelines (including guidelines on clinical data to be submitted in premarket notifications), recommendations, and other appropriate actions as the FDA deems necessary (e.g., adherence to voluntary standards). Id.
§360c(a)(1)(B). Class III devices are those for which premarket approval is required due to both the inadequacy of general and special controls for that device, and the need for the device's safety and effectiveness to be demonstrated through testing; there is a presumption that a device belongs in Class III if it is purported to be for a use in supporting or sustaining life or presents a potential unreasonable risk, id. §360c(a)(1)(C), or if it is new technology not substantially equivalent to previously marketed devices, id. § 351(f). Due to a grace period for pre-1976 Class III devices (and post-1976
substantially equivalent devices) that ends only when the FDA by rule calls for premarket approval applications (PMAs) for such devices, id. §360e(b), the U.S. marketplace includes devices that the FDA previously has identified as needing comprehensive approval, but that never have undergone such approval. The agency still needs to either call for PMAs for these devices or reclassify them, a process that Congress through deadlines in the 1990 Safe Medical Devices Act has pressed the FDA to complete. Pub. L. No. 101-629, §4(b), 104 Stat. 4511, 4515 (codified at 21 U.S.C. §360e(i).
83 Mika Reinikainen, Classification of Medical Devices, remarks at Reg. Aff. Professional Soc'y Conference on International Harmonization of Medical Device Regulation, Washington, D.C. (June 22-23, 1992).
84 Commission of the European Communities, Guidelines to the Classification of Medical Devices (Status: 1994-01-21) (3rd draft)
85 Council Directive 93/42/EEC, Art. 13.
86 The database also will include information on decisions by notified bodies that allow devices on the market and by competent authorities that take devices off the market. Norbert Anselmann, European Commission , The Forthcoming EC Directives on Medical Devices (Nov. 14, 1991)
87 CEN is the world's largest regional standards group. It promotes the harmonization of European regional technical standards for non-electrical industrial products. Its membership comprises the national standards bodies of the EU (e.g., Germany's DIN, the United Kingdom's British Standards Institute, and France's AFNOR).
88 CENELEC promotes harmonization of European regional standards in the electrotechnical field.
根據歐盟所訂標準而另訂定符合歐盟標準的國內規定
89
。若歐盟未對某醫 療器材設定標準時，製造商可自行適用適合的標準或準則90
。D.臨床試驗(Clinical Investigation)
凡醫療器材涉及人體組織時，則須符合臨床試驗的要求
91
，特別是針 對植入性的Class IIa 或 Class IIb 的醫療器材，製造商在臨床調查開始前需 等待60 天的作業時間。而臨床試驗的實施須根據 EN 540，即歐盟針對臨 床試驗所訂之標準(good clinical practices, GCPs)92
，另外International Standards Organization (ISO)也會發展相關的執行標準。E.醫療器材的品質(Quality System)
93
製造商須符合歐盟對於 Class IIa、Class IIb 及 Class III 醫療器材的品 質要求，且須經過客觀獨立的第三機關(i.e. Notified Body)認證。醫療器材 的品質標準是根據EN 46000 (採 ISO- 9000 標準)。
歐盟醫療器材分級指令一覽及上市程序相關規範94：在上市程序方面，
醫療器材指令所規定的模組可以圖 4-2 至圖 4-5 表示。CE Marketing Class I 的 器材可循A、A+E、A+D 或 A+F 模組來取得 CE 標誌，如圖 4-2；Class IIa 的 器材可循A+E、A+D、A+F 或不含設計管制的 H 模組來取得 CE 標誌，如圖 4-3；Class IIb 的器材可循 B+E、B+D、B+F 或不含設計管制的 H 模組來取得 CE 標誌，如圖 4-4；Class III 的器材可循 B+D、B+E 或包含設計管制的 H 模 組來取得CE 標誌，如圖 4-5。
89 Council Directive 93/42/EEC, Art. 5.
90 Council Directive 93/42/EEC, Art. 5.
91 Council Directive 93/42/EEC, Art. 15, annex VIII. Special requirements for custom-made devices are also prescribed in the Directive.
92 Peter Duijst & Odile Gaffori, Implications of the European Harmonization for Clinical Investigation With Medical Devices, remarks at the Reg. Aff. Professional Soc'y Conference on International Harmonization of Medical Device Regulation 3-4, Washington, D.C. (June 22-23, 1992).
94
蘇志棻，應用整合定義功能IDEF0 模式探討醫療器材產業之品質保證系統，朝陽科技大學工業工程與管理研究所碩士論文，p.11-14。