As a patient/user, you may come across several terms related to the traceability of your device. Here are a few explanations.
- Unique Device Identifier (UDI)
- Additional requirements for certain implantable medical devices (implants)
a. European implant card
b. Central Traceability Register (CTR)
- UDI: Unique device identifier
The two new regulations on medical devices and in vitro diagnostic medical devices strengthen device traceability by introducing a unique device identifier (UDI). The UDI covers all devices except custom-made medical devices and devices intended for clinical investigations or performance studies.
The UDI will be available on the device packaging (via a readable code and/or a QR code or barcode). This obligation is not currently applicable for all the relevant devices.
The UDI consists of the following elements:
- a "device identifier" (UDI-ID);
- a "production" identifier (UDI-PI).
These elements provide access to useful information about the device. The specificity of the UDI:
- improves device traceability;
- facilitates device recalls;
- combats counterfeiting;
- improves patient safety.
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In summary: The Unique Device Identifier (UDI):
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- For more information
European Commission page on UDI
- Additional requirements for certain implantable medical devices (implants)
a. European implant card
The European implant card is used to identify the implant (e.g. checks at airports).
It covers all implants, except for those listed in Article 18 of the regulations (i.e. sutures, staples, dental fillings, dental braces, dental crowns, screws, wedges, plates, guides, pins, clips and connectors).
This is a paper document in the form of a card that the manufacturer supplies with the implant. As a patient, this card is provided to you by the healthcare establishment.
This card includes:
- data about the implant;
- the date and location of implantation/explantation;
- details of the person who issued the implant;
- details of the person who performed the implantation;
- the patient's identity;
- …
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In summary: The implant card of European Regulation 2017/745:
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You can find more information in Article 18 of the Regulation.
b. Central Traceability Register (CTR)
Alongside the European implant card, there is the Central Traceability Register (CTR). The CTR aims to guarantee traceability in the event of a major incident involving an implant.
The CTR is a Belgian system that centralises the notifications of insertions and removals of implants by health professionals. It was developed in 2016, as part of the Medical Devices Plan - Traceability agreement between the medical technology industry, BeMedTech, and the Minister of Public Health. This Belgian initiative was set up prior to the new European regulations on devices and their traceability. Among other things, this agreement aims to improve implant tracking and patient identification in the event of implant removal or revision. Healthcare professionals have been obliged to use the CTR since 1 May 2021.
Every implant insertion/removal registered in the CTR generates a card in this register. This implant card is an electronic document. As a patient, you can consult this document by logging on to the MaSanté platform with an eID reader or via itsme®. If necessary, you can ask your healthcare professional to access the CTR and print the document. You can have several implant cards in the CTR (one card per notification).
However, you cannot find all your implants in the CTR. These implants must either belong to a well-defined list (see the FAQ " To which implants does it apply?") and have been implanted from May 2021, or have been registered spontaneously by your surgeon.
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In summary: The implant card of the Central Traceability Register (CTR)
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Find out more about the Central Traceability Register (CTR).