دانلود مقاله ISI انگلیسی شماره 138230
ترجمه فارسی عنوان مقاله

انتخاب ریسک کمیسیون اتحادیه اروپا برای یک استراتژی مبتنی بر عدم ریسک در ارزیابی وسایل پزشکی

عنوان انگلیسی
The EU commission's risky choice for a non-risk based strategy on assessment of medical devices
کد مقاله سال انتشار تعداد صفحات مقاله انگلیسی
138230 2017 10 صفحه PDF
منبع

Publisher : Elsevier - Science Direct (الزویر - ساینس دایرکت)

Journal : Computer Law & Security Review, Volume 33, Issue 3, June 2017, Pages 361-370

پیش نمایش مقاله
پیش نمایش مقاله  انتخاب ریسک کمیسیون اتحادیه اروپا برای یک استراتژی مبتنی بر عدم ریسک در ارزیابی وسایل پزشکی

چکیده انگلیسی

Regulation of medical devices has been one of the most notable regulatory initiatives of the European Union. The need to ensure that medical devices are of a high quality is self-evident in nature. This is demonstrated by the lack of willingness of both healthcare institutions and professionals to use medical devices that have not properly been certified. In determining which devices are medical devices and should therefore meet the requirements of the regulatory framework, both the current and the proposed frameworks foresee a central place for the concept of ‘intended purpose’. This means that only those manufacturers that have explicitly stated that their device is to be used for a medical purpose should have to comply with the medical device framework. Unfortunately, however, this concept has become increasingly problematic given the rise in mHealth (mobile health) practices and ‘appification’ (shift to mobile devices) in particular, arguably posing potentially serious risks to human health in certain cases. This article discusses the problems that are created by the ever-increasing amount of ‘well-being’ apps and the fact that most will not be classed as medical devices. Despite apparently being aware of these problems, the EU Commission has opted to maintain its current approach in the newly proposed regulation, choosing not to employ other approaches as the FDA has for example done in opting to use a ‘risk based case-by-case approach’.