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.
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