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Importance of standards

The importance of standards as the basis for quality testing and control of dental products has increased with the globalization of the market and the importance of control and approval of such products. While control regimes may differ across the world, a test certificate showing fulfilment of the requirements of a relevant standard has been a positive factor both for certification and for customers. The present regulatory system in Europe is based on Medical Device Directive 93/42 EEC (MDD). Although the fulfilment of requirements in product standards is not obligatory, most manufacturers rely on standards in compiling the technical documentation required for product approval.
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