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Spain’s Competent Authority Initiatives
Carmen Abad Luna
112 - 115
10.3233/978-1-60750-872-4-112
Studies in Health Technology and Informatics
Volume 28: Information Exchange for Medical Devices
Abstract

In Spain, only the Active Implantable Medical Device Directive has been transposed into national legislation, with the Medical Device Directive relevant Decree still in a draft edition. However, the notification of serious adverse incidents is compulsory for manufacturers and users, both for CE-marked devices and non CE-marked devices. Manufacturers of all medical devices classes must be registered at the national competent authority, though the directives do not require it.

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