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Product certification

The ADF and the AFNOR (French standards organisation) have joint authority to affix the “ADF conseille NF” mark to dental materials and equipment that comply with French standards or particular specifications..


A vital commitment to quality

Dental surgeons are responsible for the quality of the oral health care they deliver. A quality approach to the practice of dentistry relies on the use of reliable products, instruments and equipment that guarantee the patient’s safety and the best working conditions for the practitioner. Quality assurance entails, first, the development of standards, and second, the certification of the dental devices to ensure that they comply with these standards. The “ADF conseille NF’ mark was created to this purpose.


Standardisation, the first step towards quality assurance

 

Standardisation is the fundamental stage in the long and elaborate process that leads to the affixing of the “ADF conseille NF’ mark. Within the framework of a “general dental commission”, the AFNOR develops and publishes dental practice standards based on a consensus of all the interested parties – dentists, dental authorities, manufacturers, etc. – both in the private and the public sectors.

The ADF’s Medical Devices Committee is regularly involved in this work. The collaboration between the French Dental Association and the French standards organisation makes it possible for French standards – designated by the NF symbol (Norme Française) –  to be adopted as European and/or international standards..

Certification, a guarantee of standard compliance

While standardisation is the development of standards, certification is the procedure by which a product, after careful assessment, is declared to be in conformity with the specific standards that apply to it.

Manufacturers need to take active measures for their products to be certified –  they have to put in a request for certification by an accredited independent authority. Although the AFNOR is the main certifying body in France, certain professional organisations also have the approval of public authorities to certify the standard compliance of the products and services related to their sector of activity. The ADF is the accredited certifying authority for dental devices since 1982.


Systematic conformity assessment


A product can only be certified after it has been thoroughly evaluated against the specifications described in the standard it has to comply with. This implies not only that the product has to be checked and assessed in a testing laboratory, but also that the actual manufacturing processes have to be inspected for conformity.

It is important to keep these conformity assessment procedures in mind, as they constitute what clearly distinguishes product certification from the Declaration of Conformity to Essential Requirements, which is drawn up by the manufacturer alone to obtain the CE marking for products intended for exportation.


NF mark vs. CE marking

The NF mark and the CE marking are often, and quite wrongly,  considered equivalent. The CE marking affixed to a great many industrial products does not certify the quality of a product, but its safety. The Official Journal of the European Communities describes the CE marking as a mandatory marking, which indicates that a product meets all the provisions of the European Directives with regard to safety, public health, consumer protection and any other essential requirements pertaining to welfare. In this regard, the CE marking is simply a “passport” which enables the free circulation of industrial products within the European Economic Area.


The “ADF conseille NF” mark

ADF, AFNOR, LNE, a three-way partnership for the certification of dental products
Once the certification authority has ascertained that the product meets all the specifications described in the standard, the product receives a seal of approval which takes the shape of a mark affixed to it. The NF mark is the main seal of approval in France – it guarantees that the standard compliance of a product has been assessed and certified by the AFNOR.

The "ADF conseille NF" mark is affixed in the framework of a three-way agreement between the ADF, the AFNOR and the LNE (Laboratoire National d'Essais – the French national testing laboratory).
The LNE is a public company that operates under the supervision of the French Ministry for Industry. It carries out most of the testing and checking procedures necessary for NF certification on behalf of the AFNOR. Where the dental industry is concerned, the LNE conducts the entirety of the operations that lead to product certification.
Where necessary, the technical trials are completed by clinical trials set up by the Materials, Instruments and Equipment Commission of the ADF with the help of dental surgeons.

The “ADF conseille NF” mark
The AFNOR owns the NF mark, while the ADF owns the “ADF conseille” mark. Any manufacturer in the dental industry may ask for a product to be “ADF conseille” certified. The ADF has no financial interest whatsoever in the procedure. Neither does it share industrial or commercial interests with manufacturers – its sole aim is to promote good quality dental products, instruments and equipment that meet public health requirements, for the exclusive benefit of the general public and the dental profession.

How to obtain the “ADF conseille NF” mark for a product

 

Certification and affixing procedure:
-Request by manufacturer for certification by the LNE. The manufacturer has to provide a  technical file and a quality control manual.
- Inspection of the production unit, quality management system check, and  testing of samples at the LNE.
- Assessment by the LNE of the tests and inspection results. The corresponding reports are  transmitted to the manufacturer with remarks and observations, where necessary.
- Submission of the request and relevant documents to a specific committee composed of  manufacturers, consumers, and representatives from the regulatory bodies and relevant  ministries concerned by the products.
- Decision notified to the manufacturer by the LNE after consideration by the specific  committee – the request for NF certification may either be accepted and an official  authorisation issued, or it may be rejected, or the committee may ask for further  assessment.


Surveillance

Once a product has been NF certified, the production unit quality management system is inspected and sample products are tested at least once a year. The outcome of this new conformity assessment results in the manufacturer either retaining the right to affix the NF mark to his products for another year, or having that right suspended.

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