At Zimmer Biomet, we have invested significant time and resources to ensure our readiness for and compliance with the new European Union Medical Device Regulation (EU MDR) requirements. As a healthcare provider with diverse responsibilities, you may have questions about this complex subject. To assist our healthcare partners in navigating these changes, we have created this informative page. Our goal is to keep you informed about the modifications we are implementing in response to the EU MDR and how they will impact you. We acknowledge that there may be further changes ahead, but we remain committed to transparency and open communication.
This page provides answers to some potential questions you may have about the EU MDR. Please note that these responses offer a general overview and are not intended as guidance. For more detailed information on the changes, please visit the official EU MDR site.
In March 2023, the Medical Device Regulation (MDR) extended its application to devices already on the market under the Medical Device Directive (MDD). This extension, varying based on device classification, will last until the end of 2027 or 2028. The purpose is to provide ample time for manufacturers, notified bodies, and other parties involved to adequately prepare for the new requirements.
The extension of the MDR aims to minimize disruptions in the availability of medical devices in the European market and ensure a smooth transition from the previous regulatory framework (MDD) to the new one. It also allows for a phased and controlled implementation process, ensuring that all stakeholders are well-prepared to meet the new obligations outlined in the MDR.
Importantly, devices compliant with MDD that have been placed on the EU market prior to 26 May 2021 or after 26 May 2021 (within below classification specific transition periods) can continue to be used unless other limitations such as shelf life or expiry date have been met.
Dependent on the device classification and subject to certain conditions being met the extension allows for MDD certificates that were valid on May 26, 2021 (and have not been withdrawn), to remain valid until:
December 31, 2027 for:
Class III Devices and Class IIb Implantable devices
December 31, 2028 for:
All other devices (including IIb Implantable well-established technologies)
Devices that did not require a certificate under MDD but require one under EU MDR (e.g. Class Ir, Class I Software)**
**Note Class I devices that did not require a certificate under MDD and still do not under MDR did not receive an extension hence their compliance date of May 26, 2021 is unchanged.