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Akra: Time To Acknowledge EU’s Real Implementation Problems And Stop Scapegoating

 
• By Amanda Maxwell

Neither manufacturers nor notified bodies are to blame for delays in implementing the EU Regulations on medical devices and in vitro diagnostics. It is down to bad project management; there are ways forward through dialogue and compromise, but time is tight, Bassil Akra tells Medtech Insight.

Liability (Zenzen/Shutterstock.com)
• Source: Zenzen/Shutterstock.com (Business people lay the blame at)

It is wrong to blame manufacturers and notified bodies for the slow rate of compliance with the EU Medical Device and IVD Regulations (MDR and IVDR).

The responsibility for the delays lies in many areas, most of which are beyond manufacturers’ control, Bassil Akra, CEO of consultancy firm Akra Team told Medtech Insight during a recent...

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