MDR and IVDR impact in Quality Management Systems

Europe is the second biggest market in the world for medical devices and in-vitro diagnostic (IVDs) devices. Since the 1990s, regulation for these products has been relatively unchanged until 26 September 2012 when new regulatory and compliance reforms were made by the European Commission’s on medical devices (EU MDR) and in-vitro diagnostics (EU IVDR). These regulations, once implemented, replaced the existing three Medical Devices Directives (MDD) and aimed to ensure that products are effective, safe and can be freely and fairly traded throughout the EU.


On 26th May 2016, a new regulation was approved by the European Commission and gave manufacturers three years to comply with the new medical device regulation (MDR), which governs medical devices, and five years for the new in vitro diagnostic regulation (IVDR), which governs IVDs. Complying will be highly complex, because changes touch every aspect of product development, production, distribution, monitoring and, of course, the elements of the companies Quality Management Systems (QMS).


In this whitepaper we outline the impacts EU MDR and EU IVDR will have on the industry and explain in more detail the changes it implies in the QMS applications and how the Stratesys GxP Suite for Opentext is adapting to help our customers meet these new regulatory requirements.