But you also have to remember that all UK civil servants gold-plate any EU
directive to make absolutely certain they cannot be accused of having
deliberately mis-interpreted the directive to be easy to achieve, thus
enhancing the UK's position of blaming Brussels for everything that ever
goes wrong...
TIM
PLEASE NOTE - My email address has changed:
Old email: [log in to unmask]
New email: [log in to unmask]
THANKS
****************************************************************************
*********
Prof. Tim Reynolds,
Clinical Chemistry Department,
Queens Hospital,
Belvedere Rd.,
Burton-on-Trent,
STAFFORDSHIRE,
DE13 0RB,
UK.
tel: 01283 511511 ext. 4035
fax: 01283 593064
email: [log in to unmask]
alternative email for the all too frequent occasions when the NHS email
connection doesn't work:
[log in to unmask]
****************************************************************************
**********
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> -----Original Message-----
> From: Desmond Kenny [mailto:[log in to unmask]]
> Sent: 15 September 2003 15:12
> To: [log in to unmask]
> Subject: Re: CE Directive
>
>
> 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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