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Applied Drug Research, Clinical Trials and Regulatory Affairs


ISSN (Print): 2667-3371
ISSN (Online): 2667-338X

Review Article

Postmarketing Surveillance of In-vitro Diagnostic System in the European Union

Author(s): Singh Himadri*

Volume 8, Issue 1, 2021

Published on: 13 October, 2020

Page: [48 - 52] Pages: 5

DOI: 10.2174/2213476X07666201013161551

Price: $65


Advances in medical device technology and regulatory authorization adapt to changing requirements and market conditions. The assessment of safety and performance in the real-world scenario will help us understand clinical benefits and help in the evolution of the medical device and in-vitro diagnostic devices. The paradigm shift in the evaluation of medical devices and in vitro diagnostic devices will ensure that the device delivers intended benefits. This article discusses the new approach of the post-marketing surveillance in the context of new in vitro diagnostic regulation in the European Union.

Keywords: European regulation, in vitro, diagnostics, regulation, post market, risk benefit, medical device.

Graphical Abstract

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