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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.
LRQA’s medical device technical experts answer some frequently asked questions on how to implement the requirements introduced by the new regulation.
Are you prepared for the changes? The new Medical Device Regulation (MDR) was published in May 2017 and replaces the Medical Device Directive (MDD) 93/42/EEC.
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.
Classifying a medical device is an important first step for manufacturers in getting their devices into the European market.
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).