The placement of dental implants is one of the most common procedures performed in dental surgeries. It has not only aesthetic purposes such as restoring a beautiful smile, but also functional ones, to improve the patient's oral and general health.
A crucial and often overlooked aspect is the issuing by the dentist of the implant passport, a fundamental document for the management and traceability of implants and all associated prosthetic components. Added to this is the implant bearer card, a further document containing essential information on implantable devices.
But what is the difference between these two documents? Why are they so important for both the doctor and the patient?
IIn this “Questioni di Qualità” insight, we shed light on the obligations and rights of the individual parties involved.
Summary
What is the Implant Passport?
According to the reference legislation on medical devices in force to date, the EU Regulation 2017/745 (MDR), an implant passport is understood to be “any means of providing rapid access to information” set out in Article 18, namely:
- the warnings, precautions or measures to be taken by the patient;
- information on the expected life of the device and any necessary follow-up;
- the technical information identifying the device (including device name, serial number, lot number, UDI and device model) and the manufacturer's references.
This document, generally provided in paper format, is given to the patient after the first surgery and is then updated in the subsequent phases of prosthetic rehabilitation and periodic checks.
What is the bearer card?
The bearer passport, on the other hand, is a self-adhesive label bearing the data indicated in point 3 above. This label is supplied by the manufacturer of the medical device in duplicate to the dentist together with the product. After the procedure, one copy is placed in the patient's medical record and the other inside the implant passport, which remains in the patient's hands.
Advantages of the passport and the bearer card
The importance of the implant passport and the data it contains is easily understood by the clinician given the possibility of tracking the products (guarantee of origin and materials used) and the clinical indications provided in it, thus facilitating treatment. However, it also has a fundamental advantage for the patient: it allows dental care to be received anywhere in the world as it contains all the essential information useful to a possible new practitioner in the event of treatment at a different practice.
Obbligatorietà del passaporto implantare
It is important to note that with the approval of the EU Regulation 2017/745 (MDR) and following the adaptation of the Italian legislation by Legislative Decree No 137 of 2022, the implant passport has become mandatory and its non-delivery is not only negligence, but can have legal implications.
Previously, with Directive 93/42/EEC, this obligation was not formally stipulated, but the provision of the passport was already seen as synonymous with guarantee and professionalism.
It is essential to be wary of companies that do not issue passports and cards or that do not provide all the necessary information for the correct tracking of the product.
Previously, with Directive 93/42/EEC, this obligation was not formally stipulated, but the provision of the passport was already seen as synonymous with guarantee and professionalism.
It is essential to be wary of companies that do not issue passports and cards or that do not provide all the necessary information for the correct tracking of the product.
The implant passport for MaTrix dental implants
BioService Srl, always attentive to the needs of its customers, has prepared an implant passport that complies with all current regulations, without losing sight of the importance of patient safety and awareness. In addition to the required data, further information and explanations have been included to ensure adequate patient guidance.
Conclusion
The implant passport and the bearer card represent fundamental tools in the management of dental implants. They not only ensure effective traceability of devices, but also offer valuable support for the patient, facilitating access to quality dental care and optimal oral health.