Industry Needs Direction And Support As Notified Body Powers Strengthen

Gone are the days when notified bodies needed to promote themselves to gain business. Now industry is left struggling to find services ̶  and the EU regulatory outlook is becoming worrisome.

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It is becoming increasingly difficult for medtech manufacturers to find notified body capacity

Finding a notified body that has capacity to audit medical devices or IVDs is becoming increasingly difficult, not only under the Medical Device Regulation, but under the IVD Regulation too.

Manufacturers are regularly turned away because notified bodies have reached capacity. Or worse still, some are alleging that they are...

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