By Robert Zott, Director of Advisory Services
Originally Published: July 18, 2018
The publication of the new Medical Device Regulation (MDR) 2017/745 in the European Journal, with its entry into force on May 25, 2017, marks the end of an eight-year period of controversy, and the beginning of a three-year transition to the most sweeping regulatory changes since the founding of the European Union.
Since this new Medical Device Regulation has been published in its final form, the three-year transition clock has been set in motion, and the risk of many devices leaving the European market looms large in the minds of manufacturers, regulators and auditing bodies, alike.
This article explores the impact of these significant changes. Read more here!
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