The dental sector, like many other medical fields, is currently undergoing a major European regulatory transformation. This is mainly due to the introduction of Regulations (EU) 2017/745 and 2017/746, which aim to reinforce the safety and traceability of medical devices, including dental implants. As these regulatory changes come into force, they impose new obligations on you as dental surgeons in terms of documentation, traceability and communication with patients.
Here we explore the implications of the new regulations for your dental practice, the responsibilities that now fall to you, and how to help you comply simply and effectively while improving patient safety.
The new European regulations on medical devices
The entry into force of Regulations (EU) 2017/745 and 2017/746 represents a major turning point for dental practice in Europe, introducing a strengthened regulatory framework for medical devices. These legislative texts aim to improve the safety and quality of medical devices available on the market, by increasing requirements for conformity assessment, post-market surveillance and transparency towards patients.
New European regulations call for the traceability of medical devices to be harmonized throughout the European Union. To this end, two new tools have been introduced:
- The European Medical Device Database (EUDAMED): this database will centralize crucial information on medical devices, such as their identification, manufacturers and distributors. It will enable competent authorities and industry players to track medical devices throughout their life cycle, and take action in the event of a problem.
- Unique Device Identifier (UDI ): each medical device will be given a unique identifier, enabling it to be tracked individually. The UDI will be printed on the device and its packaging, and will also be listed in EUDAMED.
As with other medical devices, this new regulation introduces the obligation for dental implant manufacturers to assign a Unique Device Identifier (UDI) to each product, facilitating tracking throughout the supply chain to the end patient. This measure is essential to improve responsiveness in the event of a product recall, and to ensure better incident management.
Traceability of dental implants is therefore of vital importance, both for patient safety and for the protection of practitioners. In the event of implant failure, effective traceability means that affected batches can be quickly identified and corrective action taken. This minimizes risks to patients and reduces your potential liability as a dental surgeon.
What's more, these regulations encourage greater transparency for patients. The provision of clear, accessible information on the devices used helps to strengthen patient-practitioner trust, the key to quality dental care.
Practical implications for dentists and all professionals in the value chain
The new European regulations on medical devices, with a particular focus on dental implants, raise a number of practical implications for you as dentists, but also for the professionals who make up the value chain.
- The manufacturer is responsible for creating, affixing and recording the UDI on each product. This identifier is then listed on EUDAMED for improved traceability.
- The distributor must verify the conformity of the UDI on each medical device, and retain the UDIs for Class III implantable medical devices.
- Dentists play an essential role in the life cycle of medical devices. In relation to the device itself, they must check the validity of the UDI on all medical devices, and retain the UDIs of (at least) class III implantable medical devices. With regard to the patient, they have a real duty to inform, and provide the following information: Implant card, Manufacturer's information on the medical device used, Risks associated with the medical device, Access to information on the EUDAMED database.
In addition, they must keep abreast of medical device news (safety advisories, etc.) via IUDs, and monitor and report undesirable side effects via IUDs.
In short, these new regulations, which concern all players, aim to improve patient safety and the quality of care by strengthening the traceability and monitoring of medical devices.
Although it came into force in May 2017, it became applicable on May 26, 2021, and the transition period provided for in the regulation ends on May 26, 2024. On the other hand, an additional "end-of-sale" provision allows medical devices that are placed on the market before or during the transition period and are still in the supply chain at the end of the transition period to be made available until May 2025. This explains why a large proportion of implants in practice today do not yet have a UDI.
Until it is fully and perfectly implemented, how can you manage your patients without an implant passport?
Full traceability of implants is excellent news for the safety, follow-up and quality of patient care. That said, with implants requiring treatment on average every 10-15 years, patients rarely keeping their implant passports, and treatment carried out abroad continuing, we will continue to be confronted with unknown implants. The catalog of dental implants is vast and complex, comprising over 3,500 different models from 350 brands, and continues to pose a major challenge in terms of implant recognition and prosthetic part compatibility. Indeed, 81% of dental surgeons have already been confronted at least once with an unknown implant, which can greatly complicate patient care.
This situation is not without practical consequences: 49% of practitioners admit to having ordered the wrong prosthetic part at least once, because they were unable to correctly identify the implant. Until recently, the only option was to embark on a tedious and often fruitless search, canvassing colleagues, rummaging through obsolete catalogs or consulting prosthetists in the hope of finding reliable information.
Identifying dental implants can quickly become a tedious task, depending on the case, and the "Spotimplant" feature integrated into our Allisone software is the perfect answer.
Spotimplant by Allisone is an artificial intelligence system capable of quickly and easily identifying the reference number of a dental implant, whatever the manufacturer, based on a retroalveolar X-ray. With Spotimplant, you can find the reference number of a dental implant so you can restore the prosthesis. On the one hand, this new technology enables you to take charge of your patients (previously impossible) and, on the other, gives you all the information you need to build up a patient file with the implant's medical history.
Spotimplant also automatically provides you with a list of compatible prosthetic parts in a market place, enabling you to save time when ordering parts, gain peace of mind when it comes to component compatibility, and offer your patients fast, personalized, made-to-measure care.
The advent of the new European medical device regulations represents a major turning point for dental health professionals. By introducing stricter standards for traceability, safety and identification of dental implants, this legislation aims to guarantee a higher level of protection for patients. However, it also requires you and your patients to keep traceability and documentation records.
Innovative solutions such as Spotimplant by Allisone are emerging to help meet the goal of providing safe, high-quality care for patients.
