Historically, companies selling implantable medical devices in Europe have not been required to provide patients with device-specific information. In the event of a medical emergency, not having immediate access to this critical information predisposes the patient to a variety of unnecessary operational risks.
That changed with the European Medical Devices Regulation (MDR) modifications approved by European Council and European Parliament in 2017. These modifications expose the risks to Europeans receiving implantable medical devices without traceability of device-specific information. To address this major concern, Article 18 states that over the next three years, any implantable device being sold into Europe will be required to print specific manufacturer and device information onto an “implant card”, which will then be given to the patient/recipient. This will allow the recipient to have immediate access to critical and potentially life-saving information.
Medical Device Resource Group member, BSi, notes that this modified MDR, which replaces two previous directives, addresses concerns over the assessment of product safety and performance by placing stricter requirements on clinical evaluation and post-market clinical follow-up, and requiring better traceability of devices through the supply chain.
To aid understanding, we organized the requirements of Article 18 into three sections:
- Manufacturer Information
- Identification information of the device, including the device name, serial number, lot number, the UDI, the device model, as well as the name, address and the website of the manufacturer
- Any warnings, precautions or measures to be taken by the patient or a healthcare professional with regard to reciprocal interference with reasonably foreseeable external influences, medical examinations or environmental conditions;
- Information about the expected lifetime of the device and any necessary follow-up
- Any additional information to ensure safe use of the device by the patient.
- Printed at time of product development
- Device Information
- Information specific to the implanted device itself
- Member States “Countries” shall require health institutions to make the information available referred to in MDR Article 18, by any means that allow rapid access to that information, to any patients who have been implanted with the device, together with the implant card, which shall bear their identity.
- Exemptions: The following implants are exempted from the new requirements: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors. However, the Commission is empowered to adopt changes to this list by adding other types of implants to it or by removing implants therefrom.
Patient information, such as contact information specific to the patient receiving the device is handwritten or printed on the implant card by one of the hospital’s medical professionals. It’s worth noting that the materials selected for the implant card’s production should be able to support smudge-free pen or printers.
In conclusion, the new European Union Medical Devices Regulations (MDR) requirements are critical to ensure the safety of the patient as well as the general traceability of the implantable device. Hopefully, this breakdown helped provide a baseline understanding of the new requirements as well as expectations of the information that will need to be provided.