European Commission defines scope of custom-made medical devices.
By Dental Tribune International
BRUSSELS, Belgium: At the request of the Fédération Européenne et Internationale des Patrons Prothésistes Dentaires (FEPPD;European and international federation of dental laboratory owners and dental technicians), the European Commission has defined the scope of custom-made medical devices. According to the FEPPD, CAD/CAM technologies have enabled dentists to produce certain dental prostheses, creating unfair competition for laboratories and technicians.
Because dental laboratories and technicians were being required to adhere to the medical device regulations, but dentists were not, the FEPPD felt this was a form of discrimination. Now, according to the new specifications, custom-made dental devices for the sole use of a specific patient are subject to the requirements of the regulations on medical devices in terms of quality and traceability of materials regardless of whether the device is manufactured by a dental technician or directly by a dentist.
“This clarification with which our profession, throughout Europe, can counter the unaccountable manufacture of dental devices by dental studios, is very good news as it renders justice in creating a level playing field for all manufacturers,” said FEPPD President Laurent Munerot. “Dental prostheses are intended to be present in patients’ mouths for several decades. The greatest rigour in terms of accountability and provenance and quality of the materials used, is indispensable. It is a right of any dental patient in his role of a consumer.”
According to the FEPPD, the clarifications set out by the European Commission have removed any ambiguity on the subject: whether a dentist or a dental prosthetist, anyone producing dental prostheses will now have to comply with the same regulations.
Furthermore, the European Commission has stated that a custom-made dental prosthesis produced by CAD/CAM can under no circumstances be regarded as a mass-produced medical device, since it is intended for the sole use of a specific individual. In the case of mass-produced medical devices, that is those that are not intended for a specific patient, these would notably require the prescribing professional to carry out clinical studies on each device to prove its effectiveness.
“This second clarification is also important to us,” said Munerot. It makes clear for the FEPPD precisely where it stands in relation to other applications subject to the medical device regulations, he explained.