Dental laboratory custom-made devices : legal aspects concerning documentation and import from non-EU/EEA countries

摘要

Crowns, bridges, removable dentures and other dental appliances are custom-made medical devices and are subject to specific legislation. The EU directive 93/42 on medical devices constitutes the legislation that regulates dental laboratory custom-made medical devices. This paper investigates how importers of dental laboratory custom-made devices perform quality control and if the legal requirements for information about the medical device are being followed. Questionnaires were sent to eleven dental laboratories and conveyers who advertise import of dental laboratory custom-made devices. Seven replied. Statements that are to accompany dental laboratory custom-made medical devices were collected from Universitetstannklinikken at the University of Tromsø to investigate if they were filled out in accordance with the legal requirements. Although the legislation demands specific labeling of the custom-made devices, this is not adequately performed by the dental technicians. The law is general in its formulations and has its shortcomings in the daily clinical work of dentists and dental technicians. The existing Norwegian guidelines are outdated in some areas. Updated and more specific guidelines can be a helpful tool for dentists and technicians.