Dear list members,
The relevant parts of the directive are Recital 10:
"Whereas, having regard to the principle of subsidiarity, reagents which
are produced within health-institution laboratories for use in that
environment and are not subject to commercial transactions are not covered
by this Directive;"
and Article 1 paragraph 5:
"This Directive shall not apply to devices manufactured and used only
within the same health institution and on the premises of their manufacture
or used on premises in the immediate vicinity without having been
transferred to another legal entity. This does not affect the right of
Member State to subject such activities to appropriate protection
requirements."
If a device/reagent is used within your institution to analyse a sample
from a GP or another Trust, it is still being used "within the same health
institution". I was present during many discussions of this and other
issues while the directive was being developed, and I have never before
come across an interpretation which regards sending a test result to
another institution as "transferring a device to another legal entity"
Regards to all,
Des Kenny, Dublin
>...
>The current interpretation of the directive by MHRA considers an
institution to mean a Trust, implying that compliance with the >terms of
the directive is necessary for any in house assay which is used to analyse
samples from GPs or another Trust.
>...
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