According to data provided in April 2022 by the notified bodies, more than 90% of the currently valid AIMDD/MDD will expire in 2023-2024. While the MDR has been applicable since 26 May 2021, it provides for transitional provisions allowing medical devices certified under the AIMDD and MDD to be placed on the market until the expiry date of relevant certificates and no later than 26 May 2024.
From 27 May 2024, the MDR will be fully applicable to all medical devices and manufacturers are responsible to ensure that their devices comply with the MDR. From that date, medical devices not certified under the MDR will have no access to the EU market.
In order to ensure that devices can continue to be placed on the market, it is essential that all manufacturers adjust their system, finalize transition to the MDR and apply to a notified body, submitting complete and compliant applicants, as soon as possible and well in advance of the end of the transition period to ensure timely compliance with the MDR.
Attachment: MDCG 2022-11 - MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements
MDCG 2022-11 - MDCG Position Paper Notice to manufacturers to ensure timely compliance with MDR requirements