ABSTRACT
Annex II of the Medical Device Directive (MDD) is used frequently by manufacturers to obtain CE-marking. This procedure relies on a full quality assurance system and does not require an assessment of the individual medical device by a Notified Body. An investigation into the availability and the quality of technical documentation for Annex II devices revealed severe shortcomings, which are reported here.
Subject(s)
Documentation , Equipment and Supplies , Information Management/standards , Information Management/legislation & jurisprudence , Quality ControlABSTRACT
During the past 10-15 years, several techniques have been developed and refined for the treatment of hearing impairment and deafness. The size of hearing aids has been reduced and the sound processing has become more advanced. In the next 20 years sound processing will improve substantially. Although the reduction of size will not continue, the technical possibilities of small hearing aids will improve considerably. These developments will by and large remedy the present shortcomings of hearing aids. The functionality of cochlear implants has improved considerably in recent years, mainly due to improvements in sound processing and it is in this area in particular that improvements are expected during the next 20 years. In the area of bone conducting implants considerable improvements in the apparatus and operating techniques have been made. Minor developments are expected during the next 20 years. As a result of population growth and the aging of the population, the number of hearing aid users will probably multiply in the next 20 years from 380,000 to 523,000. The number of implant users will probably increase in this period. The bulk of the total costs for hearing devices will continue to be the supply of hearing aids.
