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<blockquote data-quote="Anonymous" data-source="post: 300518"><p>I would imagine that, with enough clinical data and evaluation of risks, that this gaget should receive CE marking by the end of the year. This is because Notified Bodies (such as BSI) evaluate the data and the design dossiers for the device, turning round applications quite quickly. As for the FDA route, well, that could take up to two years! So in that respect, we will be fairly lucky but not for much longer. The Medical Devices Directive is under review and it is likely that Notified Bodies will be under the cosh a bit more!</p></blockquote><p></p>
[QUOTE="Anonymous, post: 300518"] I would imagine that, with enough clinical data and evaluation of risks, that this gaget should receive CE marking by the end of the year. This is because Notified Bodies (such as BSI) evaluate the data and the design dossiers for the device, turning round applications quite quickly. As for the FDA route, well, that could take up to two years! So in that respect, we will be fairly lucky but not for much longer. The Medical Devices Directive is under review and it is likely that Notified Bodies will be under the cosh a bit more! [/QUOTE]
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