At 06:55 +0100 26/6/2001, John Woodgate wrote:
<36BDBCA75E0FD411A80100104B93ABF202C2C24B@mgcmail>, Dick Grobner
<[email protected]> inimitably wrote:
Referencing the Medical Device Directive, Annex I, paragraph 13.3 The label
must bear the following particulars: (l), "year of manufacture for active
devices other than those covered by (e). This indication may be included in
the batch or serial number".
One of my colleagues (in another company) was told by their Notified Body
(BSI) that it has been interpreted (by whom?) that this means the month and
year needs to be embedded into the actual serial number, such as XXZZ00001
whereas XX: month and ZZ: year (or similar).
We have never encountered this with our Notified Body (TUV). Our S/N's cross
back to a SN log which will reveal the month and year of manufacture.
Who is right? Does anyone know where this "official" interpitation is coming
from? The rational behind it?
The words 'MAY be included in the serial number' do not mean 'SHALL be
included in the serial number'. I suspect that BSI Testing is being more
Royalist than the King.
BUT, I don't think that what you are doing is correct, either. The words
'must bear .... year of manufacture' mean that the year must be stated
overtly, not just be deducible from your serial number records.
--
Dick,
I'd agree exactly with John on this. The directive requires the date
to be in a legible form, and provides for the manufacturer to use the
serial number as a way of doing this so that manufacturers who use a
suitable serial number system do not have to put both date and serial
number on if they don't want to. You may care to refer to EN1041:1998
and specifically clause 4.1.10.
Rgds
Nick.
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