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Criticisms About EU MDR’s Rule 11 For Software Classification Are ‘Unfounded’

 
• By Amanda Maxwell

When a medtech regulatory consultant receives some 500 requests in a single month on LinkedIn for a guide he has spent 300 hours writing, you know it is a critical topic.

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Interpreting Article 11 Has Provoked Numerous Questions

Interpreting and applying Rule 11, the classification rule for software which falls under the Medical Device Regulation’s Annex VIII, is proving challenging for the medical device sector.

The wording has been heavily criticized – not only by medtech manufacturers but by companies unused to medtech regulations, such...

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