Post-Marketing Surveillance and Vigilance for Medical Devices for Europe.

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Krishna Agnihotri, Anil Khokale, Ajit Gayake, Yuvraj Mahajan, Ajay Shekhare


The extent of accountability for medical device manufacturers In the early stages of the European Community Directives governing medical devices, the issue of actively monitoring product performance post pre-market approval has been a subject of persistent debate. The legal framework in Europe further adds to the complexity of this matter, with frustratingly unclear guidelines. Although specific and fairly explicit obligations exist for reporting incidents to authorities through the 'vigilance system,' there remains a significant lack of clarity regarding the extent to which manufacturers should proactively investigate and comprehend such incidents., considerable attention was devoted to crafting guidelines that could aid in interpreting the requirements for reporting under the vigilance system. However, only recently has there been a shift in focus towards elucidating the expectations surrounding post-market surveillance (PMS) in a more comprehensive manner. This article delves into the intricacies of both vigilance and post-marketing surveillance (PMS) procedures, shedding light on the current guidance documents in Europe, with a primary focus on the UK. These documents aim to promote a fair and level playing field across the industry concerning vigilance and PMS practices. The article elucidates the crucial distinctions between vigilance and post-marketing surveillance. Vigilance is outlined as the systematic procedure through which manufacturers communicate adverse incidents to regulatory authorities and subsequently exchange essential incident data among themselves. On the other hand, post-marketing surveillance is described as the method by which comprehensive information on the overall performance of a medical device is gathered and analysed.

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