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

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。

關鍵字

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

並列摘要

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.