Traceability and Medical devices vigilance
What is a medical device?
The European Medical Devices Directive (MDD) defines a ‘medical device’ as “any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for [medical] purposes [...] and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means”.
Since 1998, European Union regulations require that all medical professions in the Member States monitor the quality and safety of the medical devices used by practitioners in their daily work.
Enforcement of the Medical Devices Vigilance system in France
By French law (decree issued on 24 June 1997, repealed and replaced by decree dated 16 June 2000), manufacturers and users of medical devices – dental practitioners included – are under the obligation to report any incident or potential incident related to the use of a particular medical device, which has or could have resulted either in the death or in the serious deterioration to the state of health of the patient, the user or any other person.Notification of other types of incidents, as listed hereafter, is not mandatory :
- unwanted adverse reaction to a medical device used to its intended purpose;
- unwanted adverse reaction to a medical device not used in accordance with the manufacturer’s instructions;
- malfunction or deterioration in the characteristics or performance of a medical device;
- incorrect contra-indications, omissions and deficiencies in the instruction leaflet, the user’s guide or the maintenance manual.
A specific incident report form, which is widely available and may be obtained from the ADF, has been registered to this purpose with the CERFA (Centre d‘Enregistrement et de Révision des Formulaires Administratifs – the French regulatory body in charge of checking, harmonising and simplifying administrative forms). The practitioner, once he/she has filled the form, has to send it in the shortest time possible to the Ministry in charge of health, who will then open an investigation on the medical device concerned.
It should be underlined that, as explained in the European Guidelines on the Medical Devices Vigilance system, “The purpose of the Vigilance system is to improve the protection of the health and safety of patients, users and others by reducing the likelihood of the same type of adverse incident being repeated in different places at different times.” The reporting of an incident may in no way constitute a means of resolving a dispute between a user and the supplier of the medical device concerned.
Active involvement of the ADF
The ADF has always been proactive in the field of medical devices vigilance. It has published a number of brochures on the subject and regularly organises specific meetings during the ADF Annual Dental Meeting, in order to keep practitioners informed about regulatory provisions and their practical implications (CE marking, mandatory traceability, procedures for reporting incidents or possible incidents, etc.).