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.
As mentioned, the EU MDR places greater emphasis on a comprehensive life-cycle approach to safety vs. The Medical Devices Directive (MDD). This includes robust post-market surveillance (PMS), vigilance, and post-market clinical follow-up. Any products previously certified under the MDD must undergo reassessment to meet EU MDR requirements and obtain CE Marking certification. During the transition period, medical devices that currently comply with MDD can continue to be marketed.
What changes can be expected with EU MDR and how will it impact healthcare professionals (HCPs)?
Here's our overview of the key points you should be aware of:
Implant cards: HCPs are responsible for completing and providing the patient with patient implant cards (IC) for MDR compliant devices. Device manufacturers provide these cards with the MDR device, the Implant Card and Information for Patient (eIFP) contain crucial information about the medical device. The Implant Cards link patients to the eIFP website (https://ifp.zimmerbiomet.com/) providing access to the device specific eIFP containing a wide range of information, including warnings, precautions, expected device lifespan, necessary follow-up care, and instructions for safe device use to ensure patient safety.
There are a few exceptions, but the vast majority of Zimmer Biomet implant devices are required (once MDR compliant) to provide a patient implant card (C). The Instructions for Use (IFU) of MDR compliant products will contain the instruction to the HCP to complete the IC and hand it over to the patient.
Detailed instructions are also given in the “Zimmer Biomet Patient Implant Card Instructions for HCP” GBLF02804. To access GBLF02804, go to the Zimmer Biomet Labelling Site (https://labeling.zimmerbiomet.com/).
See Figure 1.1 - Patient Implant Card
Labelling: EU MDR labels will feature new information and symbols. For certain devices, they will also indicate the presence of restricted substances in medical devices above a specific concentration. Product labels that comply with EU MDR will clearly identify the device, its manufacturer, and provide relevant safety and performance information for the user. This information may be displayed on the device itself, on the packaging, or in the Instructions for Use (IFU).
Example Product Labels highlighting some specific additions as part of MDR (refer to See Figure 1.2 - Avenir Label):
The medical device (MD) symbol shows that the product is classified as a medical device.
eIFU symbol gives information on where to access the eIFU for the product.
The European Authorised Representative and Importer symbol and contact information.
UDI data. Provides an automated readable 2-D matrix and a Human Readable element to facilitate product traceability.
Note this is an example only, other symbols maybe required depending on how the device is impacted by MDR changes e.g.
Respectively the single or double the sterile barrier system (SBS) symbols will be present on the packaging elements which serve as sterile barriers
Instructions for Use (IFUs): One of the main goals of EU MDR is to ensure healthcare providers have a clear understanding of and effectively use medical device products. According to EU Regulation 2021/2226, certain medical devices can now provide Instructions for Use in electronic form (eIFU), identical to the paper IFU packaged with each device. However, for specific devices, eIFU can now be used instead of a paper IFU. These devices include:
Implants and active implants and their accessories
Fixed installed devices
Devices with built-in systems that display instructions
Software covered by the EU MDR
This update promotes clarity, precision, and innovation in the use of medical device products while maintaining the original objective of EU MDR. Zimmer Biomet are transitioning products to eIFU available at https://labeling.zimmerbiomet.com.
EUDAMED: The new European Database on Medical Devices (EUDAMED) will revolutionize access to information for patients and healthcare professionals. As the comprehensive window into the EU market under EU MDR, EUDAMED aims to enhance transparency and traceability. Once fully operational, healthcare professionals can effortlessly search the database for detailed manufacturer information, device registration, clinical investigations, post-market surveillance, SSCP (Summary of Safety and Clinical Performance), and more. Patients will also have access to EUDAMED, including the SSCP, empowering them to ask informed questions to healthcare professionals and stay up-to-date with the latest innovations in medical devices. Note that some modules of EUDAMED are currently not available or not mandatory, the EU Commission are planning for full functionality of EUDAMED in Second quarter 2027.