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:
- class I if they are intended for transient use;
- class IIa if they are intended for short-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity, in which case they are classified as class I; and
- class IIb if they are intended for long-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity and are not liable to be absorbed by the mucous membrane, in which case they are classified as class IIa.
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:
- ‘custom-made device’ means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.
- However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices;
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:
- the name and address of the manufacturing health institution;
- the details necessary to identify the devices;
- a declaration that the devices meet the general safety and performance requirements set out in Annex I to this Regulation and, where applicable, information on which requirements are not fully met with a reasoned justification therefor,
- the health institution draws up documentation that makes it possible to have an understanding of the manufacturing facility, the manufacturing process, the design and performance data of the devices, including the intended purpose, and that is sufficiently detailed to enable the competent authority to ascertain that the general safety and performance requirements set out in Annex I to this Regulation are met;
- the health institution takes all necessary measures to ensure that all devices are manufactured in accordance with the documentation referred to the previous points the health institution reviews experience gained from clinical use of the devices and takes all necessary corrective actions.
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.