Medical Devices

The medical regulatory landscape is undergoing its most significant overhaul in years, and with that comes a need to stay up-to-date with the latest regulatory intelligence and how the changes impact your organisation.

As a leading Notified Body with over 20 years' experience in the medical arena, LRQA’s medical technical experts and industry specialists provide best-in-class medical quality assurance, CE Marking product certification to Medical Device Directive (MDD) 93/42/EEC and In Vitro Diagnostic Device Directive (IVDD) 98/79/EC, and training services that will equip you with the relevant knowledge at any stage of the product lifecycle, towards a timely market launch.

Unlike other Notified Bodies, our unique assessment approach ensures that we truly understand your long-term business objectives in order to reduce business risk, and enhance effectiveness, efficiency, and continuous improvement of your management systems.

As part of the Lloyd’s Register (LR) Group, LRQA’s work with medical directives and CE Marking helps to ensure the safety of a range of consumer products and medical equipment, enabling us to contribute directly to a key part LR’s mission of protecting life and property.

Transition Timeline

Click on any of the standards below to check its timeline and how much time you have left to transition to the new standard.

Medical Devices Regulation (MDR)

We know medical devices

LRQA can help take the uncertainty out of the changing medical device regulations. Learn about our ISO 13485:2016


Knowledge Center

A range of valuable content and free resources about various topics like: ISO Standards Revisions, quality, environment, energy management, food safety, information security, medical devices, business continuity, risk management and others.