“It is only after being designated that Notified Bodies will be able to start re-certifying and certifying products to the MDR,” the trade group’s letter said. “Notified Bodies will typically take 3-9 months to complete a product re-certification, and it is expected that it will take them even more time for new MDR certification. Tens of thousands of medical devices will have to undergo such a process, and May 2020 is 13 months away.”
Many product categories representing tens of thousands more devices will be brought under notified body supervision for the first time and will require MDR certification before they can continue to be used, MedTech Europe said.
I hope we are not getting caught up in this.
Full story at this address -
https://www.medicaldesignandoutsourcing.com/medtech-europe-warns-of-device-flight-to-u-s-and-china-if-mdr-not-ready/
“It is only after being designated that Notified Bodies will be...
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