Exciting news for medical device manufacturers!
The amendment of Regulation (EU) 2023/607 opens up new opportunities for those transitioning their medical devices to the MDR. Legacy devices can now have the validity of their directive certificates extended (until the end of 2027/2028, depending on the device classification) if certain conditions are met.
To take advantage of this, you need to ensure that you set up an MDR-compliant QMS and submit a formal application for MDR conformity assessment to a notified body by 26 May 2024. Remember that signing a formal agreement with the Notified Body is crucial and must be done by 26 September 2024 at the latest.
Do not hesitate and submit your application to the notified body in time and preferably within the above-mentioned deadlines.
After the expiry of the certificates issued under the Directives and without a valid MDR certificate, manufacturers are no longer allowed to place these medical devices on the EU market. The overall goal of the proposed amendments is to maintain patients’ access to a wide range of medical devices while ensuring the transition to the new framework. The extension will be staggered depending on the risk class of the device, i.e. until December 2027 for devices with a higher risk and until December 2028 for medium and lower risk devices.
Official information can be found here: https://health.ec.europa.eu/system/files/2023-01/mdr_proposal.pdf