• 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.

• 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).

• 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.

• 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.

• 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.