As of January 2023, European Commission published a new press release regarding the extended transition periods of the new regulation rules on medical devices. The proposed revision on the transition periods aims to maintain the availability of safe and necessary medical devices in the market while ensuring the transition to the new framework.
Although the extension gives manufacturers ample time to meet the new guidelines and standards, it will primarily benefit manufacturers who meet certain conditions and whose devices are already on the path to transition to the new guidelines set by the Medical Devices Regulation.