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LRQA has produced a variety of useful resources about the progress and requirements of the new medical device regulation.
A comprehensive overview of the key changes which will affect all Medical Device and In-Vitro Diagnostic Medical Device manufacturers.
Are you prepared for the changes? Now in its final stages, the new Medical Device Regulation (MDR) will replace the existing Medical Device Directive (MDD) 93/42/EEC when it is published, currently estimated for Q1 2017.
This interview is a three-part series where Theresa shares her thoughts on the new regulations, and how the changing regulatory landscape impacts manufacturers and Notified Bodies.
This MDR Infographic helps highlight the key dates and changes within the new Medical Device Regulation.
An important first step for manufacturers in getting their medical device into the European market, is classifying their medical device.
The first step in the process is for manufacturers to classify their medical device based on the requirements in the new Medical Device Regulation (MDR).