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 michael.obrien@aqf.ie to arrange a meeting to discuss your medical foam requirements.