Medtech companies that sell products in the European Union have a major deadline looming — one that’s already been put off once.
The EU Medical Device Regulation (MDR) will replace the current EU Medical Device Directive (MDD) on May 26, 2021. Companies whose products are approved for sale in Europe must decide if they want to go through the process to bring those products into compliance with EU MDR.
All of this would have been time-consuming and costly, but straightforward if it weren’t for a couple of factors: the COVID-19 pandemic and the more stringent requirements on the companies that perform the audits for each device, also known as notified bodies.
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