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Introduction to the EU MDR Compliance

The European Union is the second largest global market for medical devices and often the global medical device manufacturers in the region choose to launch on their own market first because of the choice of Notified Bodies and the adoption of state-of-the-art technologies. UL customers have direct access to Notified Body technical specialists who partner with our customers and want to be a part of their success. The X Vendor Partnership culture is prevalent in our organization and is the way our team works to help our customers stay on track. Updates to proposed regulations for medical devices (MDRs) The European Commission (EC) adopted proposals for the review of the EU regulatory system. The documents were published in February 2017 and it is expected that notified bodies will qualify them for designation from 2018. When the new EU MDR comes into force, manufacturers will have four years to apply again for approval or will let their products become obsolete, since the ex