on the approximation of the laws of the Member States relating to active implantable medical devices
This Directive shall apply to active implantable medical devices.
2. For the purposes of this Directive, the following definitions shall apply:
(a) ‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combi-nation, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: Read more ...