QMA System
Acquisition equipment, their drivers and the development software utilized
in the qma system are non-invasive and comply fully with certain essential safety and administrative
requirements and are CE marked to show that they comply,
as
explained in the following excerpt:
The Medical Devices Directive - CE Marked *
Purpose
The Medical Devices Directive was enacted to provide for a
harmonized regulatory environment for all medical devices sold within the
European
Economic Area. All products which fall within the scope of the
Directive must meet certain essential safety and administrative requirements and
are to be CE marked to show that they comply. Such products may then be
freely sold throughout the EEA without being subject to additional national
regulations.
Scope
The Medical Devices Directive is one of a suite of three directives which together
cover all medical equipment. The associated directives are the Active Implantable
Medical Devices Directive (AIMDD) and the In Vitro Diagnostic Devices Directive (IVDD).
The IVDD has been enacted by the European Parliament, and it is expected that the IVDD will be fully
implemented by December 7, 2003.
The Directive defines medical devices as:
"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,
diagnosis, monitoring, treatment, or alleviation of or compensation for an injury or handicap, investigation, replacement or modification of the anatomy or of a physiological process, control of conception
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means."
Exclusions
Custom-made devices and those intended exclusively for the purposes of clinical
trials are excluded from certain of the Directive's administrative provisions, although
they must still meet the essential safety requirements and may only be applied to patients
by clinical specialists.
QMA Systems purchased and utilized in the EEA are intended exclusively for research and clinical trials.
* http://www.conformance.co.uk/CE_MARKING/ce_medical_dev.html
