The Fundamentals

As the world’s largest healthcare company, we help shape what health and wellbeing means in everyday lives. Johnson & Johnson MedTech [JJMT] has always followed the highest standards. We support EU MDR because it continues to raise the bar for patient safety and access to quality products.

EU MDR represents a significant change but what does it mean for you and why is it happening?

Healthcare Professionals (HCPs)

HCPs will be responsible for working in new ways; for example, completing implant cards post-operation for relevant devices. Labels will contain new information and symbols and IFUs must be made available in one or more official languages of the EU. HCPs will also have access to more data on the medical devices they use via a database of medical devices, EUDAMED.

Patients

One of the biggest changes for patients will be greater transparency and access to information on medical devices, provided via new features including implant cards, a patient website, a unique device identification (UDI) and EUDAMED.

Medical Device Companies

EU MDR is business critical for the global operations of companies like JJMT. Medical device manufacturers must comply with new requirements to ensure transparency and traceability to continue selling their products in markets that leverage the CE Mark.

General Public

The European Database on Medical Devices (EUDAMED) will power the EU MDR implementation by providing access to greater information about products at the click of a button. Public pages will be available for patients and HCPs will be able to view information on both the public and secure sites in EUDAMED.

Guiding You Through the Change

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These videos give a broad introduction to EU MDR and start to explain some of the key changes for HCPs and patients.

EU MDR Video Series

Where Can I Find Out More?

As a trusted partner, JJMT will support you to understand the transition to EU MDR. We have a suite of materials available including factsheets, blogs, videos and more.

If you are a Healthcare Professional, you can find important tailored information packs regarding products that are transitioning to EU MDR.

Got Questions?

Are you curious to know more about EU MDR? Here are some questions, answered…

1. What are the key changes I am likely to see in the transition from MDD to EU MDR?

  • MDD and EU MDR largely share the same basic regulatory requirements.
  • No existing requirements have been removed, but EU MDR adds new requirements.
    • EU MDR places more emphasis on a life-cycle approach to safety, supported by clinical data  
    • EU MDR brings more stringent requirements to review Technical Documentation for the designated Notified Bodies 
    • Restricted Substances, if applicable, and Device Lifetime will now appear on product labels, as well as a MD symbol and UDI barcode 
    • In some cases, these increased requirements may drive portfolio changes for medical device providers. The feasibility and cost of meeting additional evidence requirements could also result in a change to product claims
  • EUDAMED will play a central role in making data available and increasing both the quantity and quality of data.
  • To strengthen your understanding of EU MDR we encourage you to read the EU MDR Fact Sheet.

2. How will EU MDR benefit our patients?

  • EU MDR will continue to ensure the quality, safety and reliability of medical devices sold in the EU and other global markets that accept the CE mark.
  • Patients will be able to access much more information about medical devices for example, implants.
    • Patients will receive an implant card per applicable product. If multiple implants are used during a procedure the HCP may choose to affix multiple labels to a single implant card as space permits. Patients will also be provided access to electronic patient information leaflets (ePILs) via the implant card. This is a website which is an online patient resource that provides information related to the specific medical device implanted. The implant card contains a unique reference number (REF). When the patient inserts their unique reference number in the search bar on the website it will display:
      • Information about the implant described in layperson's terms
      • Warnings, precautions, or measures to be taken and expected lifetime
  • Another benefit for patients will be access to greater transparency through EUDAMED.
  • Guiding patients on how to go about accessing this information will be one of the primary changes for Health Care Professionals (HCPs) and Health Care Institutes (HCIs).

3. What will we have to do differently?

  • EU MDR requires Healthcare Professionals [HCPs] to provide patients with implant cards, if applicable, for the specific device. These implant cards include a link to the Electronic Patient Information Leaflet Website (ePIL) that provides patients with relevant information about their surgery and the implanted device.
  • Healthcare Institutes [HCIs] and HCPs will need to store UDIs for the devices they are using, per the EUMDR and national requirements.
  • HCIs and HCPs will be able to find information about specific medical devices in EUDAMED.
  • Depending on which country you’re in, the Reprocessing of Single Use Devices will need to follow a certain quality management cycle if the HCI takes this task upon themselves.
  • Our Fact Sheet on the Reprocessing of Single-Use Devices in Hospitals / Health Institutions provides further information.

4. Can I still use MDD products that I have on shelf?

  • Medical devices compliant with the Medical Device Directive/MDD remain available. The EU MDR transition period allows us to minimise disruption and ensure a smooth transition and patient access to the medical technologies they need.
  • Our EU MDR Fact Sheet provides further information on this transition and the implementation timeline for EU MDR.

5. Will product supply or availability be impacted in any way?

  • The changes associated with EU MDR could have consequences for the availability of medical devices.
  • Increased requirements may drive portfolio changes due to the overall cost of compliance.
  • There may also be some supply continuity challenges. These types of disruptions are a constant feature as our industry contends with limited external MDR certification system capacity i.e., a backlog of medical device products awaiting review and MDR approval by Notified Bodies.
  • We are also looking for longer term opportunities to expand our supply chain capacity.

From JJMT’s perspective, we’ve made a significant investment into EU MDR compliance and supply continuity to ensure we’re well positioned to support our customers.