I have been struggling to read through the original Statutory instruments
and their amendments. I am not at all sure that they necessarily have to be
interpreted in the way which MHRA are interpreting them. The definitive
interpretation lies with the Courts in any case.
Perhaps ACB/RCPath should get counsel's opinion on this?
Robert Forrest
A R W Forrest LLM, FRCP, FRCPath, CChem, FRSC
Professor of Forensic Toxicology
Medico-legal Centre
Watery Street
SHEFFIELD
S3 7ES
UK
-----Original Message-----
From: Clinical biochemistry discussion list
[mailto:[log in to unmask]]On Behalf Of Ian Young
Sent: 11 September 2003 09:11
To: [log in to unmask]
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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------ACB discussion List Information--------
This is an open discussion list for the academic and clinical
community working in clinical biochemistry.
Please note, archived messages are public and can be viewed
via the internet. Views expressed are those of the individual and
they are responsible for all message content.
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