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TEAM-NB issues Position Paper on dental implants and abutments under MDR

  • Posted by: inetika
  • Category: GLOBAL NEWS

Team-NB, the European Association of Notified Bodies for Medical Devices, has released a position paper making a proposal for dental implants and dental implant abutments to be considered as ‘exempted implants’ under the Medical Device Regulation (MDR, 2017/745).

The MDR defines specific requirements for implantable devices, placing them in one of the higher risk classes. The MDR also provides, however, a list of implantable devices which are exempt from certain obligations. These implants are first described in Article 18(3) of the MDR as: “sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors”.  The use of general terminology for the description of implants in the exemption list allows a wide interpretation of these generic terms in the respective fields of application, such as dentistry.

Dental implants and dental implant abutments are currently class IIb medical devices under the Medical Device Directive (MDD, 93/42/EEC), and this classification will not change under the MDR. MDR Article 52(5) identifies that: “Where justified in view of well-established technologies, similar to those used in the exempted devices listed . . . the Commission is empowered to adopt delegated acts in accordance with Article 115 to amend that list by adding other types of class IIb implantable devices to that list”.

The position paper argues that dental implants and dental implant abutments should be considered as specific types of screws and connectors respectively, and that the Commission should therefore adopt a delegated act to add these devices to the exempted list. The exemptions thus bestowed upon dental implants and dental implant abutments would be that:

  • Implant cards would not be required (Article 18(3));
  • Technical documentation review would be for at least one representative device per generic device group, rather than for every device (Article 52(4));
  • The requirement to perform clinical investigations would not apply under certain conditions (Article 61(6)).

Copies of the position paper can be obtained from here.