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    Title: 高風險醫療器材上市後監管之研究 - 以歐盟PIP矽膠乳房植體案為例
    A Study of Post-market Surveillance of High-risk Medical Device - From Poly Implant Prothese Silicon Breast Implant to EU Regulation
    Authors: 林盈君
    Lin, Ying-Chun
    Contributors: 馮震宇
    Fong, Zeng-Yu
    林盈君
    Lin, Ying-Chun
    Keywords: 醫療器材法規
    上市後監管
    醫療器材規則
    醫療器材指令
    高風險醫療器材
    公告機構
    PIP silicon breast implant
    Medical device regulation
    MDR
    MDD
    Schmitt v TÜV Rheinland
    Post-market surveillance
    Notified body
    Date: 2018
    Issue Date: 2019-03-04 22:06:43 (UTC+8)
    Abstract: 　　因歐盟體制與其法規發展背景的特殊性，歐盟醫療器材管制架構與其他地區之國家不同；風險較高之醫材產品於進入歐盟市場前須接受「公告機構」對產品執行歐盟符合性評鑑並授與 CE 認證，且產品上市後製造商須定期接受公告機構稽核，因此公告機構在歐盟醫材管制中佔有關鍵性功能；惟因公告機構多為民營企業，其責任義務與範圍受有諸多爭議。對於高風險醫療器材而言，上市後之監督管理至關重要，蓋多數高風險醫療器材為植入式器材，相較於其他種類醫材，植入式醫療器材本質上非常難做到從上市前的試驗完全預知產品植入人體十數年後的使用狀況與影響，需仰賴產品上市後的持續監督追蹤與不良反應通報以保護患者健康安全。
    　　2010 年法國 Poly Implant Prothèse 公司被揭露以填充床墊的廉價工業矽膠取代應以醫療級矽膠製成之乳房植體，乳房填充植體在歐盟被列為第三類最高風險醫療器材，須有公告機構執行符合性評鑑，然而 PIP 公司卻以欺瞞、製造假文件的方式矇騙公告機構，使得數十萬患者受害。本事件顯示原本管理歐盟醫療器材之「第 93/42 號醫療器材指令」有多處規範漏洞與模糊處，其中對公告機構的責任義務範圍的不明確導致 PIP 事件發生並使得受害者求償困難，此即歐盟法院 Schmitt v TÜV Rheinland 案的背景，後促成歐盟「第 2017/745 號醫療器材規則」的修法推動。
    　　本論文詳細介紹歐盟醫療器材法規順應單一內部市場發展之背景與沿革，並詳細研究 PIP 事件始末、比較新、舊法規範高風險醫療器材上市後監管之差異，再以美國高風險醫療器材上市後監管體制為參照，最後介紹我國醫材管理體制並提供建議。
    Distinct from the rest of the world, medical device regulation in the European Union was first developed to resolve the market entrance barrier among members. Under the New Legislative Framework, medical device that associates with higher potential risk must be subject to an independent third-party organization called “Notice Body” to implement the EU conformity assessment and grant CE certification before entering the EU market. After the product is listed, the manufacturer must accept periodical audits conducted by notified body. As it is, notified body plays a decisive role in EU medical device control.
    However, because most of the notified bodies are mostly private enterprises, the quasi-authority power they hold in medical device regulation had aroused numerous controversies regarding the scope of their responsibility. For high-risk medical devices, surveillance and management in post- market stage are crucial, because the characteristics of this category as most of the high-risk medical devices are implanted in human bodies. Compared to device at lower-risk, for implantable medical device, it is fundamentally difficult to achieve clinical trials that can anticipate effects of the device after it has been placed in human body for decades. As a result, it’s rather important to monitor and track adverse reactions after class III products launched.
    In 2010, Poly Implant Prothèse, a French medical device manufacturer, was revealed by French authority that PIP had been replacing medical grade silicone filled in breast implants with a cheap industrial material used for manufacturing mattresses. Breast implants are classified as class III medical device in European Union, which means there must be involvement of the Notified Body to perform conformity assessment procedure.
    Shockingly, for almost a decade, by fake data and counterfeit documents, PIP successfully deceived French authority also the notified body in charge, causing numerous patients in over 65 countries to suffer. This incident cruelly demonstrated that there were a number of loopholes and ambiguities in the management of medical device in the European Union, in particular, Medical Device Directive 93/42/EEC. The ambiguous description in the Directive regarding duties and responsibility of notified body not only had led to the occurrence of PIP incident but also set various obstacles for victims to seek compensation. This was the background of the CJEU case Schmitt v TÜV Rheinland. The expose of PIP fraud led to an overhaul of EU medical device control. In 2017, Medical Device regulation 2017/745 was published.
    This thesis will introduce detailed background and the evolution of EU medical device regulations which in line with the development of the single internal market, and give in-depth research in PIP scandal, also compare the differences of high-risk medical device post-market surveillance between MDD and MDR, and then list that of American FDA system as reference. Finally, this thesis ends with giving a general introduction of the medical device management system in Taiwan and providing humble recommendations to it.
    Reference: 壹、中文文獻
    ㄧ、書籍
    1. 王泰銓，歐洲共同體法總論，三民書局，1997 年。
    2. 洪德欽等，《歐盟法之基礎原則與實務發展（上）》，國立臺灣大學出版中心，2015 年 7 月 8 日。
    3. 洪德欽等，《歐盟法之基礎原則與實務發展（下）》，國立臺灣大學出版中心，2015 年 7 月 8 日。

    二、專書論文
    1. 邱太銘、左峻德等，我國市場監督及回收機制之研究，經濟部標準檢驗局委託台灣經濟研究院研究 ，2016 年 12 月。
    2. 顏慧欣、王煜翔等，盤點臺歐雙方機器人產業/產品相關法規，中華經濟研究院 WTO 及 RTA 中心，2016 年。
    三、期刊論文
    1. 杜培文、戴世傑、黃明權、張柏林，歐、美、日醫療器材檢驗管理制度之比較分析，台灣藥物食品檢驗局調查研究年報，第 17 期，1999 年。
    2. 吳志光，歐盟法院的訴訟類型，收錄於《歐盟法之基礎原則與實務發展（上）》，2015 年 5 月。
    3. 洪德欽，歐盟法的淵源，載於《歐盟法之基礎原則與實務發展（上）》2015 年 5 月。
    4. 陳麗娟，初探歐洲醫療器材法之現況與影響，貿易政策論叢，2013 年 12 月。
    5. 陳靜慧，歐盟法院之組織與功能，收錄於《歐盟法之基礎原則與實務發展（上）》，2015 年 5 月。
    6. 許耀明，歐盟國際私法之發展與其對國際法秩序之影響：以歐盟於盧加諾公約與海牙國際私法會議之參與為例，歐美研究，第 44 卷第 3 期，2014 年 9 月。
    7. 許耀明，歐體法院之規範角色與其法律解釋方法，收錄於《歐盟法、WTO 法與科技法》，2009 年 4 月。
    8. 淡江大學歐盟文獻中心通訊，第六期，2005 年 5 月。
    9. 黃容源，歐洲聯盟的興起、發展與前景，競爭力評論，第 7 期，2005 年 7 月。
    10.楊智傑，美國醫療資訊保護法規之初探：以 HIPAA/HITECH 之隱私規則與資安規則為中心，軍法專刊，第 60 卷第 5 期，2014 年 10 月。
    11. 蔡柏毅，歐盟「個人資料保護規則」導讀，金融聯合徵信，第三十期，2017 年 6 月。
    12. 劉如慧，歐盟環境法制與司法實踐，載於《歐盟法之基礎原則與實務發展（下）》，2015 年 5 月。
    四、學位論文
    1. 尹其言，中國大陸醫療器材法規與監督管理制度之研究，國立政治大學法學院碩士在職專班碩士論文，2016 年 4 月。
    2. 許倫彰，論歐盟內部市場貨物自由流通之規範與實踐，南華大學歐洲研究所碩士論文，2004 年。
    五、政府公開文件
    1. 吳亭瑤，赴美國參加食品藥物管理局（FDA）主辦之醫療器材主管機關論壇會議（CDRH Forum）研習報告，行政院衛生署食品藥物管理局，2010 年 12 月 6 日。
    2. 經濟部標準檢驗局，符合性評鑑（Conformity Assessment）基本概念，2018 年 3 月 21 日。下載處：https://www.bsmi.gov.tw/wSite/public/Data/f1245208915781.pdf (last visited June 26, 2018).
    3. 衛生福利部食品藥物管理署 105 年度「全球醫療器材命名系統管理應用導入研究」計畫需求說明書，2016 年 4 月。
    4. 世界衛生組織第 3 屆醫療器材全球論壇參會報告，衛生福利部食品藥物管理署，2017 年 6 月。
    5. 衛生福利部食品藥物管理署，醫療器材優良製造規範常見問答集，2015 年 7 月。
    6. 衛生福利部食品藥物管理署，醫療器材優良安全監視規範，2011 年 10 月 17 日發布。
    7. 衛生福利部食品藥物管理署，106 年 1-12 月醫療器材不良事件通報案件報表，下載網址：https://www.fda.gov.tw/TC/siteList.aspx?sid=4230 (last visited December, 20, 2018).
    六、網頁資料
    1. 中華經濟研究院 WTO 及 RTA 中心網頁：http://web.wtocenter.org.tw/Page.aspx?nid=126&pid=291436 (last visited June 26, 2018).
    2. 衛生福利部食品藥物管理署網站「申請醫療器材許可證作業程序」頁面，網址：https://www.fda.gov.tw/TC/siteListContent.aspx?sid=610&id=6716 (last visited June 26, 2018).
    3. 衛生福利部食品藥物管理署網站「推動醫療器材單一識別系統導入研究」頁面，網址：https://www.fda.gov.tw/tc/technologyContent2.aspx?id=MOHW104-FDA-D-114-000502¶m=pn%3D7%26type%3D6 (last visited June 26, 2018).
    4. 「醫療器材單一識別系統資訊管理平台」網站「常見問題問與答」頁面，網址：https://udid.fda.gov.tw/qna.aspx (last visited June 26, 2018).
    5. 衛生福利部食品藥物管理署網站，「醫療器材優良製造規範協施評鑑機構」頁面，網址：https://www.fda.gov.tw/tc/siteContent.aspx?sid=10046 (last visited June 26, 2018).
    6. 衛生福利部食品藥物管理署網站「醫療器材不良事件通報」頁面，網址：https://www.fda.gov.tw/tc/siteContent.aspx?sid=4243 (last visited June 26, 2018).
    7. 全國藥物不良反應通報系統網站之「上市後藥品不良反應通報作業」頁面，網址：https://adr.fda.gov.tw/Manager/Pages/PB010021.aspx?20130415135956969C0B925E72424781 (last visited June 26, 2018).
    8. 衛生福利部網站「醫療器材上市後主管機關警訊報告交換國際合作成果」頁面，網址：https://www.mohw.gov.tw/cp-3204-21740-1.html (last visited June 26, 2018).
    貳、外文文獻
    ㄧ、外文專書論文

    1. AFSSAPS, Situation Update on Checking Procedures Performed by the Health Authorities on the Poly Implant Prothèse Company (2012).
    2. SCENIHR, The Safety on Poly Implant Prothèse (PIP) Silicone Breast Implants (2012).
    二、外文學位論文
    1. Zhang, The Impact of Regulation on Innovation: A comparison of EU and US medical device regulation, Master Thesis of Eindhoven University of Technology (2017).
    2. Heinonen T., Go to market strategy: Role of Medical Device Regulation in EU, Master thesis of Tampere University of Applied Sciences Master’s Degree in Business Administration - International Business Management (2017).
    3. Bonadei C., ‘Obligation of Economic Operators, Traceability, Vigilance and Market Surveillance of Medical Devices as foreseen by the EU Commission Proposal for a Regulation of Medical Devices of 26 September 2012: Comparison with Existing Requirements and Evaluation’, University of Bonn, Master Thesis of Drug Regulatory Affairs (2013).
    三、外文期刊論文
    1. Altenstetter, C. ‘US Perspectives on the EU Medical Device Approval System, and Lessons Learned from the United States’, European Journal of Risk Regulation (2013). doi:10.1017/S1867299X00003093
    2. Berry, R.B. Rupture of PIP breast implants, JPRAS, Vol. 60, Issue 8 (2007). DOI: https://doi.org/10.1016/j.bjps.2007.01.069
    3. Bartolini, S. Beyond Accumulation and Technical Progress: Negative Externalities as an Engine of Economic Growth, University of Siena Economics Working Paper No. 390 (July 2003). Available at SSRN: http://dx.doi.org/10.2139/ssrn.467002
    4. Davies, G. Freedom of Contract and the Horizontal Effect of Free Movement Law, The Involvement of EU Law in Private Law Relationships, Oxford, Hart Publishing (2013).
    5. De Bruyne, Jan. A Conceptual and Comparative Analysis of the Obligations of Third-party Certifiers, OHIO NORTHERN UNIVERSITY LAW REVIEW, vol.44.2 (2018).
    6. Gollaher, D. L. & Goodall, S. Competitiveness and regulation: the FDA and the future of America’s biomedical industry. San Diego, CA: California Healthcare Institute and the Boston Consulting Group (2011).
    7. House of Commons Science and Technology Committee, Regulation of Medical Implants in the EU and UK, Fifth Report of Session 2012-13, Vol. 1 (2012).
    8. Leeuwen, PIP Breast Implants, the EU`s New Approach for Goods and Market Surveillance by Notified Bodies. European Journal of Risk Regulation, 5(3) (2014). doi:10.1017/S1867299X0000386X
    9. Lahiri, A. Waters, R. JPRAS, Locoregional silicone spread after high cohesive gel silicone implant rupture, Volume 59, Issue 8 (2006). DOI: https://doi.org/10.1016/j.bjps.2005.12.014
    10.Leeuwen, European Standardisation of Services and its Impact on Private Law: Paradoxes of Convergence, (2017).
    11. Michor, S. ‘EU Regulatory Affairs-An Historic Perspective, Fundamentals of EU Regulatory Affairs’, Sixth Edition, Regulatory Affairs Professionals Society (2012).
    12. Oosterhoff, P. Chapter 20. Medical Device Compliance: Postmarket Requirements, Fundamentals of EU Regulatory Affairs, 8th edition, RAPS Regulatory Affairs Professionals Society (2017).
    13. Purnhagen, K. Beyond Threats to Health: May Consumers Interests in Safety Trump Fundamental Freedoms in Information on Foodstuffs? Reflections on Berger v Freistaat Bayern, 38 ELR (2013).
    14. Singh, S. What is the Best Way to Supervise the Quality of Medical Devices? Searching for a Balance Between ex-ante and ex-post Regulation. European Journal of Risk Regulation, 4(4), 470 (2013). doi:10.1017/S1867299X0000310X
    四、歐盟軟性法律文件
    1. European Commission, Completing the Internal Market. White Paper from the Commission to the European Council (Milan, 28-29 June 1985), COM (85) 310 final (14 June 1985).
    2. Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards (OJ 1985 C 136, P. 0001 - 0009).
    3. European Commission Guidelines on a Medical Devices Vigilance System, MEDDEV 2.12-1 rev 8 (2013).
    4. European Parliament Resolution No 2012/2621 (RSP), P7_TA- PROV 0262 (2012).
    5. European Commission, 2013/473/EU: Commission Recommendation of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices (OJ 2013 L 253/27).
    6. European Commission, Fact Sheet - New EU rules to ensure safety of medical devices (April 2017).
    五、外文判決
    1. Judgment of the Tribunal correctionel in Marseille of 14th November 2013, (N° minute: 7206/13), (N° parquet: 12048000148).
    2. Case C-251/82, Eberhard Haug-Adrion v Frankfurter Ver- sicherungs-AG, ECR 4277 (1984).
    3. Decision of Tribunal de Commerce in Toulon of 14th June 2012 (N° de rôle: 2010F00479).
    4. Decision of Court of Appeal Aix-en-Provence of 2nd July 2015, no. 13/22482.
    5. Decision of Tribunal administratif de Toulon, 22 octobre 2015, n° 1302231.
    6. CJEU, Judgment of 16 February 2017, Elisabeth Schmitt v TÜV Rheinland LGA Products GmbH, Case C-219/15 (EU:C:2017:128).
    7. CJEU, Judgments of 14 June 2007, Medipac — Kazantzidis, C‑6/05 (EU:C:2007:337).
    8. CJEU, Judgment of 22 November 2012, Brain Products, C‑219/11 (EU:C:2012:742).
    9. CJEU, Judgment of 19 November 2009, Nordiska Dental, C‑288/08 (EU:C:2009:718).
    10. CJEU, Judgment of 24 November 2016, Lohmann & Rauscher International, C‑662/15 (EU:C:2016:903).
    11. CJEU, Judgment of 12 October 2004, Paul and Others, C‑222/02 (EU:C:2004:606).
    12. CJEU, Judgment of 10 January 2006, Skov and Bilka, (EU:C:2006:6).
    六、網頁資料
    1. BBC News, PIP breast implants health scare (Dec. 10, 2013). http://www.bbc.com/news/health-16391522 (last visited June 25, 2018).
    2. 美國食品藥物管理局站「Overview of Device Regulation」頁面，網址：https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/default.htm (last visited June 25, 2018).
    3. 歐盟執委會網頁對新立法架構的說明：https://ec.europa.eu/growth/single-market/goods/new-legislative-framework_it (last visited June 25, 2018).
    4. 歐盟執委會轄下之「內部市場、工業、創業及中小企業」部門（Internal Market, Industry, Entrepreneurship and SMEs）網站「Guidance」頁面，網址：http://ec.europa.eu/growth/sectors/medical-devices/guidance_en (last visited June 25, 2018).
    5. 歐盟執委會轄下之「內部市場、工業、創業及中小企業」部門（Internal Market, Industry, Entrepreneurship and SMEs）網站「Market surveillance and vigilance」頁面，網址：https://ec.europa.eu/growth/sectors/medical-devices/market-surveillance_en (last visited June 25, 2018).
    6. European Commission, DPO-3620.1 European Databank on Medical Devices (Eudamed) (2012). http://ec.europa.eu/dpo-register/details.htm?id=31781 (last visited June 25, 2018).
    7. Reuters, Special Report: The French breast implant scandal (2012). https://www.reuters.com/article/us-breast-implants-mas/special-report-the-french-breast-implant-scandal-idUSTRE8110WY20120202 (last visited June 25, 2018).
    8. MHRA, Medical Device Alert - Immediate Action Update, Ref: MDA/2010/078. Download link: https://assets.publishing.service.gov.uk/media/5485ac2bed915d4c10000299/con096758.pdf (last visited June 25, 2018).
    9. AFSSAPS, Press Release ‘Résultats des tests sur les implants mammaires à base de gel de silicone de la société Poly Implant Prothèse’ (28-Sep-2012). Download link: http://ansm.sante.fr/content/download/27936/370699/version/2/file/point-info-fichePIP.pdf (last visited June 25, 2018).
    10. European Parliament, Press Release: PIP Breast Implants: learn the lessons of this fraud (26-Apr-2012). http://www.europarl.europa.eu/news/en/pressroom/content/20120423IPR43732/ (last visited June 25, 2018).
    11. Judicial activity 2017 Annual Report of the Court of Justice (2018). Download site: https://curia.europa.eu/jcms/jcms/Jo2_7000/en/ (last visited June 26, 2018).
    12. European Parliament, European Parliament Resolution of 14 June 2012 on defective silicon gel breast implants made by French company PIP (2012). http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//TEXT+TA+P7-TA-2012-0262+0+DOC+XML+V0//EN (last visited June 26, 2018).
    13. European Commission, NCAR Statistics - EU 2017, Publication date: 04/01/2018. 可至歐盟執委會網頁下載 http://ec.europa.eu/docsroom/documents/27121 (last visited June 26, 2018).
    14. 歐盟執委會網站「Accreditation of conformity assessment bodies」頁面，網址：http://ec.europa.eu/growth/single-market/goods/building-blocks/accreditation_en (last visited June 26, 2018).
    15. 歐盟執委會轄下之「內部市場、工業、創業及中小企業」部門（Internal Market, Industry, Entrepreneurship and SMEs）網站「Medical devices」頁面，網址：https://ec.europa.eu/growth/sectors/medical-devices_en (last visited June 26, 2018).
    16. Eucomed, ‘Towards a regulation that guarantees patient safety, ensures patient access and keeps innovation in Europe.’ http://www.medtecheurope.org/node/673 (last visited June 26, 2018).
    17. The Telegraph Health News, Faulty medical implants investigation: Patients’ health put at risk by unscrupulous EU regulators (22 Oct 2012). https://www.telegraph.co.uk/news/health/news/9626756/Faulty-medical-implants-investigation-Patients-health-put-at-risk-by-unscrupulous-EU-regulators.html (last visited June 26, 2018).
    18. U.S. Food and Drug Administration, Medical Device and Radiological Health Regulations Come of Age, FDA Consumer magazine, The Centennial Edition (2006). Access: https://www.fda.gov/downloads/AboutFDA/WhatWeDo/History/ProductRegulation/UCM593521.pdf (last visited June 26, 2018).
    19. 美國 FDA 網站「Medical Device Reporting」頁面：https://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm (last visited June 26, 2018).
    20.美國 FDA 網站「MedWatch Voluntary Reporting Form」頁面：https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home (last visited June 26, 2018).
    21. 美國 FDA 網站「HIPAA Compliance for Reporters to FDA MedWatch」頁面：https://www.fda.gov/Safety/MedWatch/HowToReport/ucm085589.htm (last visited June 26, 2018).
    22. CDRH, Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act - Guidance for Industry and Food and Drug Administration Staff (May 16, 2016). Access link: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm268141.pdf (last visited June 26, 2018).
    23. 美國 FDA 網站「Medical Device Reporting Regulation History」頁面，網址： https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/ucm127985.htm (last visited June 26, 2018).
    24. FDA Small Business Regulatory Education for Industry (REdI) - FDA Medical Device Inspections (September 30, 2015). Download link：https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM466499.pdf (last visited June 26, 2018).
    25. 美國 FDA 網站「Medical Device Single Audit Program」頁面，網址：https://www.fda.gov/MedicalDevices/InternationalPrograms/MDSAPPilot/ (last visited June 26, 2018).
    26. FDA, Medical Device Single Audit Program Frequently Asked Questions, Version 016 (2017-08-22). PDF link: https://www.fda.gov/downloads/MedicalDevices/InternationalPrograms/MDSAPPilot/UCM430563.pdf (last visited June 26, 2018).
    27. 美國 FDA 網站「Recalls, Corrections and Removals (Devices)」頁面，網址：https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/RecallsCorrectionsAndRemovals/ (last visited June 26, 2018).
    28.Asian Harmonization Working Party 網站之 Representative of Member Country or Region 頁面：http://www.ahwp.info/index.php?q=node/80 (last visited December, 18, 2018).
    29. Emergo 網站，News: Medical Device QMS Harmonization: US Considers Aligning to ISO 13485，網址：https://www.emergobyul.com/blog/2018/05/medical-device-qms-harmonization-us-considers-aligning-iso-13485 (last visited December, 20, 2018).
    Description: 碩士
    國立政治大學
    法律科際整合研究所
    105652008
    Source URI: http://thesis.lib.nccu.edu.tw/record/#G0105652008
    Data Type: thesis
    DOI: 10.6814/THE.NCCU.LAWID.001.2019.F10
    Appears in Collections:[Graduate Institute of Law and Interdisciplinary Studies] Theses

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