There is no either/or choice between the essential
requirements and the harmonised standards. You
must always meet the essential requirements. If it
is found that your equipment fails to meet the
essential requirements despite meeting the harmonised
standards the equipment will still be in breach of the
directive and sale of it may be prohibited. It will however
be presumed to meet the essential requirements until
this is shown. This means that the authorities cannot
demand any futher proof of compliance with the
directive before you are allowed to market it unless
they have good reason to believe it fails the essential
requirements. If your product does meet the harmonised
standards and you had no good reason to believe that,
despite this, it failed the essential requirements you
would stand an excelient chance of sucessfully pleading
due diligence but this would not stop the equipment
being banned until rectified.
The other possible routes, beside harmonised standards,
to showing compliance with the essential requirements
vary with the directive and the type of equipment. In the
EMC directive, for equipment other than
radiocommunication transmitters you may use any
other suitable means provided this is given in a
technical constuction file and approved by a
competent body. For radiocommunication transmitters
type examination will require compliance to harmonised
standards, usually certified by an accredited test house.
The LVD will allow you to use any other means to
show compliance to the essential requirements but
from next year you must have a detailed justification
ready in advance.
To your specific questions,
1. Yes you do have to meet all normative references
if they apply.
1.a Yes even if they are not themselves listed in the OJ
2.If you have your compliance to the harmonised standards
certified by some approved body, either because you
have to or you choose to, they will tell you of the relevant
standards, but in choosing they will rely on your
information as to the application of your equipment if
this is not obvious. You bear responsibility for the
correct standards being applied but again if you rely
on a body approved for that pupose by the direcive and
have given them accurate information you should be
able to plead due diligence. If you are allowed to, and
choose to test to the standards yourself you will have to
search the standards youself and decide which is
applicable.
3. Most harmonised standards have date of withdrawal
of conflicting standards that is several years after the
date of publication. This allows the older standards to be
applied until the date of withdrawal in those cases
where there was an older standard or in those cases
where they have been called indirectly by an undated
reference. If they are called indirectly by a dated
reference the new standard does not apply until
the reference is updated. The revised Memorandum
6 from CENELEC calls for a 4 year transition
period for new standards but leaves unclear some
matters where the scope of a standard changes.
4.Non-question, see above
Nick Rouse
