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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TÜV SÜD has become the second notified body to be officially designated under the EU’s Medical Devices Regulation (2017/745) after BSI UK. The Commission’s Nando database on notified bodies was updated to reflect this latest development on 22 May.

The good news for industry is that the activities of the Germany-based organization will not ostensibly be impacted negatively by Brexit, although all NBs will be under pressure from capacity...

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