Conformity with Medical Device Directive / EEC is mandatory all devices that fit the definition of a. 'medical device' and its accessories.. This directive is.
There are three Medical Device Directives in place, the Directive of Active Implantable Medical Devices the Medical Devices Directive (/ EEC).
Council Directive / EEC of 14 June 1993 concerning medical devices. Official Journal L 169, P. 0001 - Finnish special edition: Chapter.
(93/42/EEC) - list
It is prohibited to affix marks or inscriptions which are likely to mislead third parties with regard to the meaning or the graphics of the CE marking. This declaration must cover a given number of the products manufactured and be kept by the manufacturer. The decision must be notified to the manufacturer. Guidelines on Medical Devices With Measuring Function. Main page Contents Featured content Current events Random article Donate to Wikipedia Wikipedia store. All products in the batch may be put on the market except any in the sample which failed to conform. In areas for which no standards exist, the symbols and colours must be described in the documentation supplied with the device. If the type conforms to the provisions of this Directive, the notified body (93/42/EEC) the applicant with an EC type-examination certificate. Application (93/42/EEC) the quality system must ensure that the products conform to the type described in the EC type-examination certificate. The manufacturer (93/42/EEC) his authorized representative established in the Community must make this documentation, including the declaration of conformity, 1932 English cricket season to the national authorities for (93/42/EEC) purposes for a period ending at least five years after the last product has been manufactured. (93/42/EEC) applicable, the CE marking must also appear on the sales packaging. In particular safety with regard to viruses and other transferable agents must be addressed by implementation of validated methods of elimination or viral inactivation in the course of the manufacturing process. Bioptron Interview with Dr. pakistan-karachi.info