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 ...

of 14 June 1993 concerning medical devices
1 . This Directive shall apply to medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as medical devices in their own right. Both medical devices and accessories shall hereinafter be termed devices. Whereas, in the fight against AIDS and in the light of the conclusions of the
2 . For the purposes of this Directive, the following definitions shall apply:
(a ) 'medical device' means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of: — diagnosis, prevention, monitoring, treatment or alleviation of disease, Read more ...

of 6 November 2001 on the Community code relating to medicinal products for human use
For the purposes of this Directive, the following terms shall bear the following meanings:
1. Proprietary medicinal product:
Any ready-prepared medicinal product placed on the market under a special name and in a special pack.
2.
Medicinal product:
Any substance or combination of substances presented for treating or preventing disease in human beings. It is necessary to take account of changes arising as a result of international harmonisation of definitions, terminology and technological developments in the field of pharmacovigilance. The increasing use of electronic networks for communication of information on adverse reactions to medicinal products marketed in the Community is intended to allow competent authorities to share the information at the same time. Read more ...

on the recognition of professional qualifications

This Directive establishes rules according to which a Member State which makes access to or pursuit of a regulated profes-sion in its territory contingent upon possession of specific professional qualifications (referred to hereinafter as the host Member State) shall recognise professional qualifications obtained in one or more other Member States (referred to here-inafter as the home Member State) and which allow the holder of the said qualifications to pursue the same profession there, for access to and pursuit of that profession. Read more ...

on the application of patients’ rights in cross-border healthcare

This Directive provides rules for facilitating the access to safe and high-quality cross-border healthcare and promotes cooperation on healthcare between Member States, in full respect of national competencies in organising and delivering healthcare. This Directive also aims at clarifying its relationship with the existing framework on the coordination of social security systems, Regulation (EC) No 883/2004, with a view to application of patients’ rights. Read more ...

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