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How Will Europe’s New Device Regulations Affect Medical Software?

04 Jun 2021

Wolfgang Schoenig spoke to Medical Technology Magazine about the implications for medical device software following the rollout of the European Union’s new Medical Device Regulation (MDR) last month.

“It is likely that more apps will be governed by the revised regulation, because the scope has been broadened to cover both prediction and prognosis applications, whereas previously it was only prevention,” Wolfgang said. “This might result in a larger number of software solutions falling within the scope of the MDR.”

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