FEPPD, the European Federation of Dental Labs and Dental Technicians is contacting you to share important information regarding the uniform interpretation of the status of “manufacturer” in the scope of the Medical Devices Regulation.
The FEPPD Board, has been following for quite some time, rumours coming from the dentist’s lobby with regards to their unwillingness to adhere and implement the new Medical Devices Regulation, even if themselves are manufactures of dental devices when they make use of CAD/CAM units.
A controversial Court sentence in 2015 by the Tribunale di Vicenza, Italy, which not respected the spirit of the MDD in terms of the obligations that are to be met with by manufacturers of dental devices , freed a dentist from his not issuing the Certificate of Conformity following the fitting on a patient of a dental device produced from a CAD/CAM in his dental studio, on the grounds that the device was produced from a Cerec block, interpreting it, as being a device “adapted” from a mass produced medical device, and therefore not subject to the legal requisites of the MDD.
A gross misinterpretation of facts and findings beyond reality.
Since then, the Dentist’s lobby and their organisations were spreading the word that they could
manufacture dental devices without being considered as manufacturers at law, thus doing without the obligation of going through all the dynamics the MDD, and now the MDR.
This situation not only proved to be discriminatory in our regards, it also gave an advantage to them in entering our market whilst doing away with the obligations we, as the rightful manufacturers of dental devices, are made to meet through the burden of documentation, post manufacturing responsibilities and the scrutiny of the authorities that regulate our profession.
The FEPPD Council took the initiative to seek the authoritative interpretation of what establishes a
“Manufacturer” as prescribed by both the MDD and the MDR, directly from the legal office within the E.U. Commission, that was responsible for the drafting and enacting of the MDR.
We are very pleased to announce to you, that from the info we were forwarded, it clearly identified as a Manufacturer, whoever fulfils such definition as described in Art. 2 (30) of the MDR, whether it being a dental technician or otherwise a dentist producing custom made dental devices via a CAD/CAM unit.
It has been established as a state of fact, that invariably from the legal technicalities in phraseology used in the MDR, when a dental device is produced for the sole use of an individual patient, irrelevant whether it was manufactured by a dentist or a dental technician, the moment the device has been fitted to the patient, such activity falls squarely under the MDR’s parameters, obliging whoever manufactured it, to implement all the requisites of the Regulation.
At this, dentists are being imposed to adhere to the MDR in full, since a device manufactured in their dental studio, not only is part of a service provided to their patient, it is to all effects a custom made dental device, thus made to comply with the Regulation.
Finally, with regards to the abusive interpretation that a Cerec block as ‘adapted’ according to the dentist, it has been established that a raw ceramic block can never be adapted, but machined in a mechanical process to manufacture a custom made dental device.
Summing up all the facts as established by the E.U. Legal Office, dentists who will carry on manufacturing dental devices themselves, are obliged to comply with the MDR as manufacturers, accountable as much as dental labs are to conform with the requisites of the MDR, and equally punishable at law if they fail to honour the Regulation in all its mechanisms.
With all these clarifications at hand, FEPPD in its mission statement to protect dental technicians and detal labs in their rights and legal standing, is once more providing an informative service meant to uphold your professional status, guaranteeing a level playing field with our direct competitors.
By sharing with your organisation this important fact finding, FEPPD is proving itself that it has at heart the interest of all European dental technician’s organisations. since this is a matter of utmost importance to all the dental technology movement.
With this information we are providing, now you have the means of upholding the terms of the MDR.
Whereby dental labs have to meet all the requisites of the Regulation, you are now in a position to report to your authorities any abuse from dental studios who in manufacturing dental devices and do not fulfill likewise the mandatory application of issuing the Certificate of Conformity and adopt all related
mechanisms within the MDR as manufacturers of custom made dental devices.
FEPPD INVITES THE DENTAL TECHNICIANS ASSOCIATIONS TO JOIN AS MEMBERS IN OUR ORGANISATION
This way your organisation will always be informed about current issues, be at the centre of what is relevant to our business, having also the opportunity to discuss and propose issues that can be beneficial to your members.
We recommend all organisations to download the Regulation (EU) 2017/745, available in all languages, in order to document yourselves with the requisites of the MDR, since it is the law that regards our day to day activities and establishes our legal rights and obligations.
The Board at FEPPD sends its best regards and remains committed to your best interests.