Medical device labeling is considered as important as classifying a product or creating an insulation diagram. In IEC 60601-1, labeling is deemed "a critical component of a medical device." 1 The ...

This week, on June 14, 2016, the FDA issued a final ruling revising its medical device and certain biological product labeling regulations to allow, for the first time, manufacturers to use graphical ...

A medical device is an umbrella term for any instrument, software, or other article used alone or in combination for a medical purpose in humans. An estimated 2 million different kinds of medical ...

A review of the background, mission and statutory requirements of medical device regulation in the United States has been published. The report highlights the differences between regulation guiding ...

Concerns over the EU’s agonizingly clunky roll-out of the Medical Device Regulation (MDR) has largely focused on the capacity of notified bodies to manage the task of recertifying CE marks for legacy ...

Dublin, July 22, 2022 (GLOBE NEWSWIRE) -- The "An Introduction to the Medical Device Regulation Training Course" conference has been added to ResearchAndMarkets.com's offering. This is an excellent ...

In recent times, there has been an unprecedented level of public interest and active debate regarding the regulation of medical devices. Although medicines and devices are regulated under European ...

The EU Medical Device Regulation goes into application on 26 May 2020, with the In Vitro Diagnostic Medical Device Regulation set to follow on 26 May 2022. These new Regulations bring sweeping changes ...

The trend towards personalized medicines in Europe requires a more integrated framework that regulates the approval of devices and diagnostics. In Europe, the regulation of medical devices has ...

Niti Aayog’s Medical Devices (Safety, Effectiveness and Innovation) Bill is the latest in India's seemingly never-ending attempt to introduce a comprehensive and effective medical device regulation, ...