Latest EUMDR Updates

Latest EUMDR Updates

In response to the COVID-19 pandemic, EU regulators proposed a one-year delay on the new EU MDR, to May 2021.

The EU MDR Date of Application has officially been extended until May 2021. While most Regulatory Affairs and Quality Control professionals are rejoicing in this push-back, keep the ball rolling on meeting new MDR compliance. Those scrambling to review their products’ compliance may be able to exhale, but the race to completion is still on.

In 2017, EU came out with the new MDR, that would go into effect in 2020. Since then, medical device manufacturers have been tasked with determining which of their products need to be re-registered with participating Notified Bodies, in order to meet the new regulations for export in the EU. However, this posed a new problem for RA professionals.

The once lengthy list of Notified Bodies has now dwindled to only a handful. This poses a great problem for many manufacturers as Notified Bodies become more and more overwhelmed with products to register.

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