Why EU App Makers May Need A Notified Body More Often Than They Realized

German Dispute Over Product Risk Classification Threatens To Engulf EU Device Regulations

 
• By Amanda Maxwell

Any apps, or indeed any software, which assist communication in the medical field need to be carefully evaluated against a tricky-to-comprehend rule in the EU’s Medical Device Regulation.

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• Source: Shutterstock

Critics claim Rule 11 concerning software classification in the scope of the EU Medical Device Regulation (MDR) is difficult to interpret and apply. 

Such criticism has been leveled by many companies already familiar with the MDR, but interpreting Rule 11 has been particularly challenging for those who may be new to

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