August 15, 2022

[FEATURED] Latest Italian Designation Means Germany and Italy Are Home to Half EU’s MDR Notified Bodies

While each new designation of a notified bodies in the medtech space is good news, many more organizations are needed rapidly to help manage growing demand. Capacity warnings continue..

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June 13, 2019

[FEATURED] EU Officially Designates Second Notified Body Under The MDR: TÜV SÜD Enters Center Stage

TÜV SÜD, headquartered in Germany, is the second notified body to be officially designated under the EU MDR. Is this good news going to significantly lessen medtech industry’s concerns over delays in accessing the new, tougher regulatory system for medical technology, with time running seriously short?

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April 23, 2019

[FEATRURED] One In Three Medtech Innovators Will Be ‘Driven Out Of Business’ By EU MDR, German Business Survey Finds

The EU Medical Device Regulation is 15 months away from being implemented in full, and a new German survey about its potential impact on the medtech innovation and patient-care landscape makes for sobering reading.

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