Background::
Medical devices are the machine, tool, instrument, apparatus, implant,
calibrator in vitro, software, the similar or related object intended for use by the manufacturer
alone or in combination becoming increasingly important in the healthcare sector as these are used
to diagnosis, control, prevention or treatment of an illness. Safety of the world population is the
highest priority in order to launch new medical devices for the treatment and diagnostic of several
diseases. New innovation in industries and regulations work together to provide devices for different
world market and to improve quality and safety of exiting devices in the market. The main key
for devices is to classify the determination of actual regulatory pathway which ensures the safety
standards and other regulatory requirements in a specific country. We perform clinical trials for
medical device which are quite different from the clinical trials performed for drug analysis. For
any high-risk devices, the new EU law states that the manufacturer has to prepare a complete
summary for their evidence. The clinical trials regulation provides more transparency on clinical
trials data. Complete transparency is required for the maximum possibility of informed decisions
in order to use new medical devices.
Objective::
The current manuscript will provide the information regarding the regulatory framework
for the approval of medical devices and clinical investigation of medical device in European
Union and comparison of approval process of medical device in USA, EU and India. The aim of
this paper is to provide an overview of the most suitable and emerging requirements that manufacturers
need for introducing their medical devices in the market in compliance with the MDR regulations.
Conclusion::
The proposal for a modified regulation of medical devices aims to ensure more robust
clinical data in support of the CE marking applications of the medical device. The clinical investigation
requirements will be mandatory, and there will be an obligation to demonstrate the
clinical benefits of the device and provide a rigorous equivalence test if the assessment is based on
comparison devices. The new European legislation should require the premarket demonstration of
clinical efficacy and safety, using a randomized controlled trial if possible, and a transparent clinical
review, preferably centralized.
A review of medical device regulations in India, comparison with European Union and way-ahead
