I take your point Richard, but I did not make mine very clearly and
so you have missed it.
Irrespective of the wording of some of the Directives and the
guidance, since there is no absolute requirement (except in the
medical devices directives) to appoint an Authorised Representative
within the EU, any 'requirement' to keep the documentation on EU soil
is both nonsensical and unenforceable. If the manufacturer is outside
the Community and there is no Authorised Representative, who is going
to hold the file, and how will any enforcement action be taken?
I know the pat answer is 'the person responsible for importing the
product into the EU' but what if they are also outside the EU? In
many cases the only person located within the EU is the end user and
you can't seriously tell me that the authorities expect that every
time a manufacturer ships to a new end user in the EU they are going
to have to supply a copy of their Technical File with the goods!
The Directives are in a bit of a mess on this topic but frankly it
probably isn't in anyone's interests to sort it out since the current
fudge allows everyone involved to do their own thing without having
to obviously break any rules. I can't see the WTO liking a move by
the Europeans to force non-EU manufacturers to formally appoint an
Authorised Representative, even if such a move were the answer to the
problem, and actually (for reasons which are explained on my web site
at http://www.conformance.co.uk/CE_MARKING/reps.html) I don't
actually think it is the answer anyway.
Regards
Nick.
At 10:23 am +0000 11/12/02, Richard Hughes wrote:
Nick,
Unfortunately, regarding the last para, you have not followed your
own good advice of checking with the specific EU Directives
concerned.
Annex IV section 2 of the LVD requires:
"The manufacturer must establish the technical documentation
described in point 3 and he or his authorized representative
established within the Community must keep it on Community territory
at the disposal of the relevant national authorities for inspection
purposes for a period ending at least 10 years after the last
product has been manufactured."
Not surprisingly, the Commission's Guide to the LVD (2001 edition) states:
"This technical documentation must be kept within the Community."
On the other hand, the R&TTED does not state that the technical
documentation must be kept within the Community. The corresponding
para to the above (Annex II section 2) requires that:
"The manufacturer must establish the technical documentation
described in point 4 and he or his authorised representative
established within the Community must keep it for a period ending at
least 10 years after the last product has been manufactured at the
disposal of the relevant national authorities of any Member State
for inspection purposes."
Note that the part requiring that the technical documentation be
kept "on Community territory" is absent.
Equally, the LVD and the R&TTED have different requirements
regarding the provision of a DoC. See Article 6(3) of the R&TTED.
Own opinions as always,
Richard Hughes
-----Original Message-----
From: Nick Williams
[<mailto:[email protected]>mailto:[email protected]]
Sent: 11 December 2002 00:12
To: Stephen Irving
Cc: [email protected]
Subject: Re: Location of CE DoCs
These are indeed rumors. Different Directives have different
requirements in this regard, and although the general rules of thumb
that documentation should be kept in the EU and a copy of the DofC
should be supplied with the product provide a good working basis for
compliance with the Directives, they are by no means mandatory for
all equipment under all New Approach directives. If it really matters
to you, you should read the text of the specific directives which
apply to your products in order to find out what is required.
As examples, neither the LVD nor the EMC Directives require a copy of
the EC declaration to be shipped with the product, although the
Machinery Directive does. None of these three directives require the
appointment of an Authorised Representative (only the medical devices
directives do this) and ergo there is no requirement for the
technical file to be 'kept on EU soil'.
Regards
Nick.
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