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How to launch your Medical Device

LRQA’s guide to the MDR Conformity Assessment Procedures will help you understand the different routes to compliance, and which route applies to your medical device.

How to Launch Your In Vitro Diagnostic Device

Then, based on the classification of the IVD, manufacturers can identify the appropriate conformity assessment route for their product. This route will determine the required activities manufacturers will need to comply with in order to receive a CE marking.

LRQA MDR and IVDR Webinars

The new Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) will replace the existing Medical Device Directive (MDD) 93/42/EEC and In Vitro Diagnostic Device (IVD) Directive 98/79/EC. Both Regulations are currently in their final stage of development and are expected to be published towards the end of Q1 2017.