IVD Directive - Expectations and Implications

摘要

Within the framework of common European legislation, the "new approach" Directives play an important role. A directive is a legislative document issued by the European Council of Ministers and the European Parliament, to be implemented by the member states. Implementation is means that the member states must issue appropriate national legislation to make the directive function in the particular member state. There is a time limit for the implementation, which for the IVD directive is December 2003.