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.
The EU MDR (Medical Device Regulation) extends its impact beyond EU countries. Non-EU countries that require the CE mark for their products may also face implications. Manufacturers from third countries must familiarise themselves with the regulations and obligations under the MDR and IVDR (In Vitro Diagnostic Medical Devices Regulation) to place devices on the EU market. Transition periods are in place, allowing coexistence of devices compliant with previous directives and current regulations. It is crucial for third countries relying on the CE marking to inform relevant stakeholders and ensure compliance with requirements and timelines.
Please use our contact form if you have any questions specific to your region.