Manufacture of dental prostheses: the European Commission defines the scope of its regulation on Custom made Medical Devices
The European Commission, at the request of the Fédération Européenne des Prothésistes Dentaires (European Federation of Dental Technicians and Lab owners), specified that a custom made dental device for the single use of a patient, remains subject to the requirements of the regulations on medical devices in terms of quality and traceability of materials, regardless of whether it is manufactured by a dental technician or directly by a dental surgeon.
In this respect, the dental lab business has been subject to unfair competition since the development of new digital technologies (Computer Aided Design, Printing and 3D Machining) that has allowed dental surgeons to produce certain dental prostheses directly in their own practices, but not fulfilled their obligation as manufacturers of dental devices. At this, the dental prosthetists’ profession was discriminated, as was expressed by a spokesman from the Fédération Européenne des Prothésistes Dentaires (FEPPD), by the wrong interpretation surrounding the scope of European regulations on medical devices, as intended by the dentist’s lobby.
Voted by the European Parliament and entered into force on 27 May, would this regulation also apply to dental surgeons equipped with CAD/CAM or 3D printers, under cover of being health professionals, would they be able to exempt themselves from the obligations of the MDR in terms of quality and traceability of materials which have long applied to the profession of dental technicians?
Accountability, quality and traceability of materials
In setting the record straight, in clarifications sent to the FEPPD, the European Commission has just removed any ambiguity on the subject: once a dental prosthesis is produced for the exclusive use of a patient, its manufacturer falls under the regulations on custom made medical devices and obliges its manufacturer, whether they are a dental surgeon or a dental prosthetist, to comply with the same regulations (quality and traceability of materials, certificate of conformity, etc.), as contained in the new Medical Devices Regulation.
« 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 », underlines Laurent Munerot, the president of the FEPPD, « 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 «
Custom made dental prostheses
The letter from the European Commission also states that under no circumstances should a custom made dental prosthesis, produced by a CAD/CAM, be regarded as a « mass produced medical device », since the said manufacture is intended for the single use of an individual. In the case of mass produced medical devices, not intended for a specific patient, these would notably require the prescribing professional to carry out clinical studies on each device, to prove their effectiveness.
« This second clarification is also important to us », adds Laurent Munerot, « Our Organisation is thus able to know precisely where it stands in relation to other applications within the MDR ».
Founded in 1953 under the original name Fédération internationale de la prothèse dentaire (The International Federation of Dental Prosthetics), the Fédération européenne et internationale des patrons prothésistes dentaires (European and International Federation of Dental Prosthetists) is the European organisation, that represents 40,000 dental laboratories and 210,000 dental technicians at European level.