Medical Devices

Many of the world’s leading medical companies choose LRQA.

LRQA is a leading notified body for the Medical Devices Directive and the In Vitro Diagnostic (IVD) Devices Directive.  We provide conformity assessment services and CE Certification under all device classifications.

Where a directive requires products to be independently tested, inspected or certified, this must be undertaken by a body approved for the purpose of the directive by a government of the community and notified to the European Commission. 

Bodies can be notified for all medical device conformity assessment routes in the directive or for individual ones. The requirement of the routes will determine the type of organization which is notified. For example, for a route which stipulates type-examination the notified body would normally be a test house or product certification body. 

With 20 years’ experience as a notified body, LRQA has established an in-depth knowledge and understanding of certification within the IVD and medical devices sector. Our assessors are industry specialists and experts, enabling an effective and robust assessment of your system.

Contact us to learn more about medical device certification

MDR

Medical Devices Directive - New Regulation

IVDR

In-Vitro Diagnostic Directive - New EU IVDR