Quality

Intended use, responsibility, surveillance

The 93/42EEC directive on medical devices (acknowledged by the Italian government as Legislative Decree n. 46 dated February 14, 1997, and subsequent modifications) is the official reference that dictates the regulations for marketing medical devices. The directive provides indications for all the phases of existence for the device (from design through traceability, and surveillance), and it identifies all the characters who have to comply with the directive itself, which includes not only the manufactures, but also the distributors, the buyers and the users. With the main object to warrant the constancy of performance, and the security in the use of all marketed devices, the directive states that “a medical device is any instrument, apparatus, appliance, material or other article, used alone or in combination, intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of a disease…” and that the intended use is the use for which the device is intended according to the indications provided by the manufacturer on the labelling, in the instructions and or in promotional materials. With regard to their intended use, implants for orthodontic anchorages, dental implants, and osteodistractors, are classified as Class IIB medical devices, according to rule 8 of annex IX of the 93/42EEC directive, due to the fact that they are implantable devices, i.e. devices that are intended to be totally introduced into the human body or partially introduced into the human body through surgical intervention, and intended to remain in place after the procedure at least thirty days; for the conformity to the 93/42EEC directive the manufacturer must follow the specific procedures for Class IIB devices. The conformity of a medical device that is manufactured in series is demonstrated through the presence of the CE marking on the product label. The CE marking warrants that the product satisfies the requirements for security and adequacy, provided that the device is used with the expected indications and modalities that are reported on the explanatory leaflet.

The use of a medical device in a way which is dissimilar from manufacture’s directions regarding indications/modalities for use represents an “improper use” of the device. Every responsibility for damage that may derive from this improper use would be attributed, entirely or partially, to the user and not to the manufacturer (here including the reutilization of devices that are marked as “for single use” by the manufacturer); responsibility may be attributed to the distributor as well, since he may have neglected or eliminated indications and warnings by the manufacturer during the marketing phase. More specifically, the label of every package that contains orthodontic implants, dental implants and osteodistractors, shows the CE0120 marking that identifies the authorising Notified Body Yarsley International Certification Services that verified the conformity of Leone products. Further, the label specifies the name and address of the manufacturer, the information/warnings for use and maintenance of the product, and the information for the correct identification of the product (code and lot number). This latter information is needed in order to guarantee the traceability of the product, with regard to both used materials and final users. As emphasised in the directive, in facts, all the characters that get in contact with the medical device with various aims and responsibilities are involved in the permanent activity of surveillance. Manufacturers and distributors must implement systems that permit the traceability of the product from the initial manufacturing process through the final use. The final user has the duty of a surveillance activity aimed to detect any malfunction or deterioration in the characteristics or performances of a device, along with any inadequacy in labelling or in the instructions for use that might lead to or might have led to the death or a serious deterioration in the state of health of a patient or user. In serious or potentially serious situations an immediate report is due, and it must be directed to the Ministry for Health. Even regardless of the severity of the situation, all the medical operators must make a report of the dysfunctions or lack of conformity of the device or associated materials (labels, explanatory leaflet) that they may detect during their activity. The goal of this surveillance is to guarantee a careful check of the efficacy and functionally of the medical devices in the course time. As for the responsibilities of the single competence, Leone S.p.A. recommends to its direct clients, dental depots and exclusive dealers to follow and maintain the indications, warnings, and information for the univocal identification of the medical devices, as provided by the manufacturer on the labels, during all the marketing phases. With specific regard to Class IIB products for implantology, all dental depots and exclusive dealers of Leone S.p.A. are required to keep records of the distribution of medical devices on traceability available for verification, in case of need to trace back a product or its user in a univocal way.

Leone S.p.A.