| Summary: | 碩士 === 國立政治大學 === 法律科際整合研究所 === 107 === 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.
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