Dear All,
CE marking of "in house" systems.
I apologise if this has been clarified already, but I recently attended an
excellent presentation by Sue Spencer (Bayer User Group Meeting, Keele). I
understood her to say that "in house" systems DO need to be CE marked if
the results are requested by OR TRANSMITTED TO any body ("legal entity")
outside the unit performing the investigation. This means, I think, that if
a lab performs a test for a GP for example (different PCT), as we all do,
then "in house" assays must be CE marked.
This may have particular ramifications for labs performing Down's screening
as this system is listed in Annex Two, List B. Assay AND SOFTWARE are
mentioned specifically, so CE marking is needed if you send results outside
your own trust and are using "in house" assays (including kit assays
used "off label" for Down's screening, as most are) or "in house" software
(as many of you are). The particular concern about being in "Annex Two" is
that the CE marking process is more rigorous.
Sue gave a couple of helpful web addresses:
An article she has written :
http://www.devicelink.com/ivdt/archive/03/04/008.html and the MHRA web site
http//www.mhra.gov.uk
I hope I have quoted Sue correctly and that you find this information to be
of some interest but not too much of a worry - the deadline seems to be 7th
December!
Andy Ellis
UK NEQAS
Edinburgh
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