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Rules - IVDD European Harmonized StandardsToday there are four European harmonized standards on in vitro diagnostic medical devices and more than fifteen are presently in the course of preparation. The standards reflect the requirements of the Directives in a more specific and detailed way.These standards are prepared by the European Standardization bodies CEN and CENELEC and follow a mandate issued by the European Commission. Provided that the manufacturer complies with these standards the requirements of the Directive, which the standards concern, are automatically fulfilled. However, it is up to the manufacturers to decide whether they wish to follow the standards or if they in another way are able to prove that the requirements have been fulfilled. Back to index |
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