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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Vydané v:	Annals of internal medicine Ročník 176; číslo 6; s. 844
Hlavní autori:	Bretthauer, Michael, Gerke, Sara, Hassan, Cesare, Ahmad, Omer F, Mori, Yuichi
Médium:	Journal Article
Jazyk:	English
Vydavateľské údaje:	United States 01.06.2023
Predmet:	Certification European Union Humans Medical Device Legislation Patient Safety
ISSN:	1539-3704, 1539-3704
On-line prístup:	Zistit podrobnosti o prístupe
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