The New European Medical Device Regulation: Balancing Innovation and Patient Safety

The European Union has introduced stricter provisions for medical devices under the new Medical Device Regulation (MDR). The MDR increases requirements for clinical trial testing for many devices before they can legally be placed on the market and extends requirements for rigorous clinical surveilla...

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Veröffentlicht in:	Annals of internal medicine Jg. 176; H. 6; S. 844
Hauptverfasser:	Bretthauer, Michael, Gerke, Sara, Hassan, Cesare, Ahmad, Omer F, Mori, Yuichi
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	United States 01.06.2023
Schlagworte:	Certification European Union Humans Medical Device Legislation Patient Safety
ISSN:	1539-3704, 1539-3704
Online-Zugang:	Weitere Angaben
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