Spain's competent authority initiatives.
1996
: 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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