The new European regulation on medical devices (EU Regulation 2017/745) was published in the Official Journal of the Union on 5 April, its entry into force was 26 May 2017 and the application (mandatory) 3 years Later, in May 2020. As a reminder, contrary to a directive, such as 93/42, which must be declared in the various national laws, a regulation immediately applies in the law of the 28 member states. It is actually written in all the languages of the Union, it can be easily found on the site of the OJEU.
The dental industry is particularly impacted by this new regulation. Historically, dental has always been treated with less demand than other medical devices. That remains true. Thus, Rule 5 (Chapter III of Annex VIII) confirms the particular class of invasive devices used in the mouth. Here is the text:
All invasive devices with respect to body orifices, other than surgically invasive devices, which are not intended for connection to an active device or which are intended for connection to a class I active device are classified as:
The dental devices for filling a tooth are therefore generally class IIa, the dental implants are class IIb.
When a new idea emerges, the Americans transform it into business, the Chinese copy it and the Europeans regulate it.
Emma Marcegaglia, the former patroness of the Italian bosses
However, a number of provisions of the regulation will impact the dental industry; These are those on custom-made medical devices.
Article 2 of Chapter I sets out the different definitions of the Regulation. Paragraph 3 contains the new definition of a custom-made device:
This new second paragraph lacks precision and creates a deleterious situation for the profession. Indeed, there is no definition of what a mass-produced device is or what is an industrial manufacturing processes. For some regulatory specialists, the use of an additive or subtractive FAO manufacturing process falls within the scope of this definition. Thus, according to these people, Cerec © or 3D printer solutions would make prostheses produced by these devices Medical Devices with all the related requirements. This impacts the practitioners and, more importantly, the dental laboratories. Indeed, the mountain of obligations linked to the medical CE marking of health products is impassable by the overwhelming majority of European prosthesis laboratories
A provision of the text that reinforces, even more, the feeling that the CAD-CAM in the cabinet is threatened is Article 5.5 of Chapter II. This paragraph establishes the rules for the manufacture of Medical Devices by health institutions (including dental offices). While the text provides that custom-made devices can be manufactured by healthcare institutions, there are restrictions and new obligations. The obligations of the hospitals or offices that manufacture their prostheses in situ will now be as follows:
• the health institution draws up a declaration which it shall make publicly available, including:
Chairside cad-cam exemple in Montreal, Canada
By providing the requested documents, manufacturers of CAD / CAM solutions will facilitate the day-to-day work of practitioners; The fact remains that this will be a particularly heavy and engaging new administrative burden.
It is in subparagraph (c) of this article 5.5 that there is a question for the practitioners: ”the health institution justifies in its documentation that the target patient group's specific needs cannot be met, or cannot be met at the appropriate level of performance by an equivalent device available on the market”.
It can be understood that an orthopedic surgeon cannot find a suitable prosthesis for a particular patient suffering from serious trauma or the consequences of cancer. But for dentists, such an assertion is inaccurate. Indeed, dental laboratories can argue that they are better able to meet the requirements of the Regulation than practitioners; Especially, when some of them will declare themselves as manufacturers of Medical Devices. Thus, it will be impossible for practitioners to claim that there are no satisfactory Medical Devices on the market except to prove that the manufacturing within the hour of the prosthesis is an absolute necessity.
A other provision of the regulation weakens the arguments for the manufacture of the prosthesis in the cabinet. The Regulation requires that a person responsible for ensuring compliance with the regulations be appointed to the manufacturers of Medical Devices (Article 15). This does not apply to custom-made devices. However, paragraph 1.b states: “Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate the requisite expertise referred to in the first subparagraph by having at least two years of professional experience within a relevant field of manufacturing”. I anticipate the argument of practitioners who will remind that in France, they are responsible for the design of the prosthesis. However, I am concerned that a court will question their experience in the manufacture of prostheses.
The temptation is great to say that, given the low dangerousness of the products concerned, the authorities (ANSM for France, Ministry of Health, etc..) will not focus on dental prostheses. Moreover, that the regulation will not enter force until May 2020. Finally, that the wording is too vague to be able to affirm, without doubt, that the chairside cad-cam was condemned by the European regulation 2017/745.
Yet, it would be irresponsible to make to put our head in the sand; Because there are real doubts that should be quickly lifted: not only is 2020 tomorrow (besides that this can already slow down today's investments of practitioners) but, especially, if the subject is raised by the dental labs unions before the dentists unions or dental devices manufacturers do it, it is a safe bet that the politicians but even more the judges will adopt a strict reading of the regulations which would certainly be fatal to the chair-side CAD-CAM.
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