Section K — The voluntary clinical consultation on the clinical development strategy (Article 61(2))

Source: MDCG-2020-01.pdf page 31 (document: MDCG 2020-13)

Add a clear description of any remaining minor non-compliance together with required follow-up actions to close them and timelines for their completion to be followed by the manufacturer.

Section K: The voluntary clinical consultation on the clinical development strategy (Article 61(2))

Expert Panel consultation reference:

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Expert Panel recommendations:

Have the views of the expert panel been given due consideration by the manufacturer?

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Has this been included in the clinical evaluation report?

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Is there any divergence between the manufacturers clinical development strategy and the views of the expert panel? If yes – what is the justification for this? Is this acceptable? Explain why.

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