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

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

Volume: 8

Author(s): Singh Himadri*

Affiliation:

• Stem Cell Research department, National Institute of Nutrition, Tarnaka, Hyderabad,India

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

Abstract: 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.

Cite this article as:

Himadri Singh *, Postmarketing Surveillance of In-vitro Diagnostic System in the European Union, Applied Drug Research, Clinical Trials and Regulatory Affairs 2021; 8 (1) . https://dx.doi.org/10.2174/2213476X07666201013161551