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Medical Devices Act

In 1993 the European Commission published the European directive 93/42/EWG - better known as the Medical Devices Act. The EU and EFTA member states were obliged to adopt the Medical Devices Act into national law by June 1998 and to revoke all previous laws on this issue. The Medical Devices Act stipulates characteristics and functions in medical devices without determining any precise details of certain products, as that would require a continuous reworking of the law. Therefore, the contents of the act apply to "essential requirements" of a medical device. Those requirements define properties to ensure that the security of the patient and the treating team is not jeopardised but rather increased by using this medical device. As medical devices, surgical protective clothes and surgical drapes are assigned to the lowest risk category.