Shortage of MDR Notified Bodies: Crisis Averted or Crisis Delayed?

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The decision to push back MDR’s implementation date by one year ostensibly bought companies and regulators time to prepare for the new system. But there remains a continuing scarcity of new notified bodies. Is that an indication that European officials are just kicking the can down the road so that industry can still expect a bottleneck, just one year later?

At the risk of dating myself, watching what is going on with the impending European Medical Device Regulation (MDR) reminds me of the Monty Python TV sketch that opens with the line, “No one expects the Spanish Inquisition!”


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