Just a quick note to say that the programme of the West Midlands ACB National Clinical Audit meeting on 27th November 2003 at the QE post graduate centre -
see
http://www.acbwm.org.uk/meetings/nationalaudit.html -
contains a presentation by Sue Spencer on the topic of in-house assays, the IVD directive and CE marking followed by a short discussion period.
regards to all
Jonathan Middle
WMACB Regional Rep
-----Original Message-----
From: Ian Young <[log in to unmask]>
To: [log in to unmask]
Date: Thu, 11 Sep 2003 17:11:18 +0100
Subject: Re: CE Directive
> IN ACB News this week there is an article about CE-marking. This specifies
> that if devices are used in-house they do not have to be CE marked. But if
> they are used by anyone else they must be [so receiving tests from another
> hopital means that tests must be CE marked at great expense. Does anyone
> know what counts as another body?
I am currently corresponding on behalf of the ACB with MHRA
about the In vitro diagnostics directive (in my capacity as
Chair of the Scientific Committee). The articles in ACB news are
a good summary of the current position. 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. Clearly this has very
wide implications. It would be much better if the MHRA would
interpret the directive differently (for instance, the whole NHS
could be considered to be one body), but this is not currently
the case. There are many examples (such as the urine collection
bottle case which Tim raises) where further clarification is
probably required, so I will be very interested to hear list
members views and comments before I commence my next round of
correspondence with MHRA.
Best wishes
Ian Young
----------------------
Professor IS Young
Department of Medicine
Wellcome Research Laboratories
Mulhouse Building
Royal Victoria Hospital
Grosvenor Road
Belfast BT12 6BJ
Northern Ireland
tel: +44 2890 632743
fax: +44 2890 235900
[log in to unmask]
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