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Manufacturers and associations call for changes to EU medical device regulation

BERLIN, Germany: Five years into its application, the EU Medical Device Regulation 2017/745 (MDR) is reshaping how medical and dental devices reach patients...

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FDA changes stance on dental amalgam

WHITE OAK, Md., U.S.: The U.S. Food and Drug Administration (FDA) has updated its guidance for the use of dental amalgam in tooth restorations. The agency ...

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FDA issues amendment for medical device submissions

SILVER SPRING, Md., U.S.: As dental workflows continue to become increasingly digitally based, so, too, do certain regulatory processes. The U.S. Food and ...

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Investigation highlights lack of consistent medical regulation

LONDON, UK: An investigation headed by the International Consortium of Investigative Journalists (ICIJ) has found that patients worldwide have potentially ...

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European Parliament adopts new medical device regulations

BRUSSELS, Belgium: The European Parliament has voted to implement two new regulations concerning medical devices with the aim of improving safety in ...

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