QUOTED. Dec 15, 2017. Jaap Laufer.
Executive SummaryEmergo's Jaap Laufer says the oncoming Medical Device and IVD Regulations have serious flaws that could lead to the demise of the EU notified body system. Check out what he says might result.
"In my opinion, the notified body system for medical devices is bound to disappear under a successor piece of legislation that will establish an 'EMDA,' a European Medical Devices Agency that will absorb the major notified bodies, as we know them, into national agencies." – Jaap Laufer, medical director, Emergo
> Find out more: MDR And IVDR Fail Risk-Benefit Assessment, EU Reg Expert Says
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