The European Association of Medical Devices – Notified Bodies (Team NB) issued a position paper describing the application of an exemption rule regarding the endosseous dental implants and dental implant abutments.
Dental Implants: Brief Overview
According to the general rule, set forth by the Medical Device Regulation 2017/745 (MDR), Class III medical devices and implantable medical devices are defined as higher risk class devices and thus should be subject to specific safety and performance requirements. At the same time, some of the medical devices falling within the category described above are subject to an exemption. In particular, the list of exempted devices includes, among other, sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors. The appropriate list is indicated in Article 18 (3) of the MDR. However, as it was mentioned by Team NB, the application of the MDR with regard to dental implants still lacks legal clarity. The proposal issued by the association is intended to provide additional details regarding this issue and assist notified bodies in applying the aforementioned provisions.
It is also important to mention that the document covers only the devices based on the well-established technologies (WET), while the devices that are entirely new or based on the novel technologies are excluded from its scope.
According to the Medical Device Directive, dental implants are Class IIb medical devices. The MDR defines implantable medical devices as ones intended to be totally introduced into the human body or replace its surface. Another criterion used to identify implantable devices is the duration of use: under the general rule, an implantable device shall remain into the patient’s body after finishing the procedure for at least 30 days.
Implants Exemption Rules
In accordance with the general rule prescribed by both the Directive and the MDR, implantable devices are higher risk devices under the risk-based classification. At the same time, certain implants listed above are exempted from particular requirements. Another exclusion is based on the technologies such devices are based on. If the implantable device subject to review utilizes well-established technologies, the same as ones used in similar devices already available on the market. It is also important to mention that the MDR actually does not provide the definition of the well-established technologies (WET) that creates uncertainty in the interpretation of this term. The same is applicable to other common terms used in the regulation, such as “screws” or “connectors”.
The existing framework also provides additional separation of implantable devices within the same risk groups. Such an approach is based on the position that the use of exempted medical devices is associated with the lower risk. The document provides the list of criteria a dental implant shall meet in order to be suitable for the exemption rule, namely:
- It should be determined as an implant in accordance with the exemption list, and
- It should be based on well-established technology.
Device-Specific Rules and Requirements
The document also provides detailed requirements related to the dental implants and similar devices subject to the exemption. In particular, the guidance covers the following types of devices:
- Dental Implants
- Determination (identification) criterion: since there is no any definition of a “screw” in any of the medical devices regulation, Team NB suggests using general engineering definition. According to the guidance, dental implants could be identified as screws for the purpose of applying exemption rules. The document also contains an image illustrating various types of screws provided below.
- WET criterion: dental implants have been used for half of the century and their design remains almost the same in spite of certain minor changes and modifications. All dental implants are based on the same approach and utilize the same principle. Thus, all dental implants could be determined as those matching the WET criterion. This is also applicable to the materials used in manufacturing dental implants: most of them are made from titanium or titanium alloy, so the manufacturing method already constitutes state-of-the-art. At the same time, some of the dental implants could be based on the application of novel technologies, such as 3D printing or ceramic processing. In such cases, the dental implants created using such approaches would constitute an entirely new device and that could not be subject to the exemption rule due to the WET criterion. The document also provides an image illustrating the dental implants covered by the abovementioned rule (provided).
- Dental Implant Abutments
- Identification requirement: since the “connector” term also has no officially provided definition, the informal description could be used. In particular, a dental implant abutment is an element connecting the crown (the dental restoration) with the dental implant itself. Thus, due to the function of dental implant abutments, Team NB finds reasonable to determine them as “connectors” for the purpose of applying the exemption rule. To illustrate the function performed by the dental implant abutments, the document includes the scheme of an assembled dental implant containing all its elements: dental implant (the screw), dental implant abutment (the connector) and dental restoration (the crown).
- WET criterion: the technologies used when manufacturing dental implant abutments have been developing simultaneously with the development of dental implants themselves. Thus, Team NB suggests that such technologies meet the WET criterion.
Summary of the Dental Implant Regulation and Exemption Rule Applicability
According to the information provided in the document, both dental implants and dental implant abutments meet the suitability criteria for the exemption rule introduced by the MDR. In particular, the Team NB emphasizes on the following core points:
- The lists of exempted devices included in the Regulation 2017/745 contain terms that have no definitions in the appropriate medical device regulations. Thus, the use of general terminologies creates opportunities for using various interpretations.
- To be suitable for the exemption rule, the device should be based on the well-established technology (WET).
- According to the justification provided by the Team NB, dental implants could be defined as screws, while dental implant abutments meet the definition of connectors.
- Almost all dental implants and dental implant abutments are based on the well-established state-of-the-art technologies and practices that have been used for many years. Entirely new dental implants and ones based on the novel technologies should be excluded from the scope of the exemption rule.
How Can RegDesk Help?
RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.