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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.

Are you a self-certified IVD manufacturer?

Under the existing IVDD, approximately 80% of IVD manufacturers are self-certified and do not require Notified Body involvement. The new IVDR comes with new classification rules which will in the near future require about 80% of IVD manufacturers to require some form of Notified Body involvement, a four-fold increment from before.

ISO 13485:2016 - Understanding Risk Management Implications

In this 20 minute webcast, Susan Mecca, Senior Technical Manager, Medical Devices - LRQA Americas, will provide practical guidance and real-world application and implementation of some of the new additions and revisions in ISO 13485:2016, particularly those around Risk Management and the Interconnection with other Regulatory Requirements to the corresponding Medical Device Directives (MDD) and In Vitro Diagnostic Medical Devices (IVDD).