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 firstname.lastname@example.org to arrange a meeting to discuss your medical foam requirements.