Medical Devices Directive (MDD) Help & Guidance

LRQA has produced a variety of useful resources about the progress and requirements of the new medical device regulation.

Medical Device Regulation (MDR) Guide

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.


LRQA’s medical device technical experts answer some frequently asked questions on how to implement the requirements introduced by the new regulation.

Theresa Jeary three-part series interview

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.

MDR Infographic

This MDR Infographic helps highlight the key dates and changes within the new Medical Device Regulation.