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No Valid Excuses For Manufacturers To Delay IVD Regulations Applications, Experts Warn

 
• By Amanda Maxwell

Too many perceived factors are being used by IVD manufacturers to unnecessarily delay progressing their applications under the IVD Regulation with potentially serious consequences. Three well-known medtech regulatory experts explain why manufacturers must act now.

Don't Wait sign with clouds and sky background
• Source: Shutterstock

Manufacturers need to apply now for certification under the IVD Regulation, or further bottlenecks could form later down the line when deadlines approach for each of the risk classes.

Nor is there any excuse why they should delay further. There are no significant backlogs at EU notified bodies for the assessment of these products, contrary to recent reports

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More from Geography

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