Jul 24, 2019

The European Medical Device Coordination Group (MDCG) has adopted a guidance document on implant cards, assisting in understanding article 18 of the Medical Devices Regulation (EU) 2017/745 (MDR).

According to the guidance, implant cards are intended for patients to be able to identify information about devices that is published elsewhere, for example in Eudamed. It is also intended for the patient to identify themselves in case of field safety corrective action (FSCA) or other issue.

Emergency clinical staff or first responders may also use implant cards to obtain information about special care or needs for patients in emergency situations. The implant card must be provided to patients by healthcare professionals, which implies that Member States must draw up specific legislation. Manufacturers are asked to create an informative instruction leaflet to instruct healthcare providers in the use of the implant card, and the effectiveness of these instructions must be verified by a usability study. For ease of use, the implant card should have the same size and shape as a credit card.

Information to be provided

The implant card must clearly identify the device and provide any relevant additional information:

  • Device name;
  • Serial number or lot or batch number;
  • Unique device identification (UDI) in human and machine readable format;
  • Name, address and the website of manufacturer;
  • Website of the manufacturer;
  • Device type.

In addition, the patient and the healthcare provider must be identified on the implant card:

  • Name of the patient or patient ID;
  • Name and address of the healthcare institution which performed the implantation;
  • Date of implantation.

Symbols are allowed to convey this data. Some new symbols are introduced:

  • Patient name or patient ID
  • Date of implantation
  • Name and address of the implanting healthcare institution/provider
  • Information website for patients
  • Device Name

The symbol for the device name is particularly interesting. It looks like the medical device’s version of the IVD symbol, but apparently this is not the case.

Implantable systems

If a patient is implanted with a set of components that are intended to work together, this is considered an implantable system. Some of these components may later be replaced. The exact components to be implanted may not be known to the manufacturer at the moment the device leaves the place where the implant card is added to the package. This means that system cards require a certain flexibility. A suggestion is made of how a system card could look like, but the guidance document encourages parties involved to look into ways to developing implant cards that fit the specific situation for the system in question.

UDI

Article 18 of the MDR requires the UDI to be represented on the implant card. In the guidance document this is understood as the UDI-DI of the device, both in machine and human readable format. However, article 27 states that a UDI consists of a UDI-DI (the device identifier), plus the UDI-PI (the production identifier). Annex VI, part C, which contains the UDI-related definitions, confirms this by stating that UDI comprises the UDI-DI and the UDI-PI. However, there is a risk that conformity with the guidance document – only the UDI-DI on the card – results in a non-conformity with the MDR. There is a way to meet both requirements: article 18 requires the UDI plus serial number and/or lot number to be on the implant card. This would imply that if the UDI-PI contains the serial number or lot number, the requirement would be fully met by stating the UDI-DI plus UDI-PI.

Summary of Safety and Clinical Performance

One of the three reasons for issuing an implant card is that it allows a patient to identify the summary of a device’s safety and clinical performance in Eudamed. That document is required for all implantable devices, without exceptions. However, the implant card is not required for “simple” implants, sutures, staples, dental filling, etc. This means that manufacturers of the “simple” implants need to provide summaries of safety and clinical performance, while their patients will not be able to identify them. It would have made sense using the same exceptions for both cases. Unfortunately MDCG cannot change the MDR, so for now we have to live with this inconsistency.

Additional European MDR resources from Emergo by UL:

  • On-site MDR training for manufacturers
  • European MDR gap assessment and CE Mark transition strategy
  • Whitepaper: Understanding Europe’s Medical Devices Regulation (MDR)