MDCG Position Paper Notice to manufacturers to ensure timely
compliance with MDR requirements

  • In April 2022, 75% of notified bodies indicated that more than 50% of the submitted applications were deemed incomplete.
  • 90% of currently valid AIMDD/MDD certificates will expire in 2023-2024. 
  • From 27 May 2024, medical devices not certified under the MDR will have no access to the EU market.
  • 30 notified bodies are designated under the MDR, managing around 80% of current AIMDD/MDD certificates. 

Please contact Michael O’Brien at to arrange a meeting to discuss your medical foam requirements.

The article’s source can be viewed here.

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