Andy description of the situation is generally correct according
to the the current MHRA interpretation of the directive. It
seems at present as if the UK is alone in Europe in interpreting
the directive in this way, and ongoing attampts are being made
by various parties to encourage MHRA to look again at their
interpretation.
An additional important point, however, is that the directive
contains two transtition periods. The first, ending om 7
December 2003, applies to the placing of devices on the market.
The second, which ends 7 December 2005, applies to the putting
into service of Devices. If you are putting a device into
service but not placing it on the market you do not need to
comply with the requirements until 2005, if the device satisfies
the requirements in force on 7th December 1998. In effect,
therefore, any IVD currently in use can continue to be put into
service until 7th December 2005 before it is essential to comply
with the requirements.
I hope that this is clear to everyone!
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
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