CE Marking Documentation List
1. The technical documentation must enable the
conformity of the product with the essential requirements to
be assessed.
2. It must cover the
- design,
- manufacture and
- operation of the product, in particular a general description of
the product,
- manufacturing drawings and
- schemes of components, sub-assemblies, circuits, etc.,
- descriptions and explanations necessary for the understanding
of said drawings and schemes and
- the operation of the product,
- a list of the standards referred to in Article 5, applied in full
or in part, and
- descriptions and explanations of the solutions adopted to meet
the essential requirements of the Directive
- results of design calculations made, examinations carried out,
etc.,
- test reports.
3. The D-o-C must also demonstrate tracability to the
actual product: with the following
- Valid date: how can a 2, 3 or 4 year old date be valid?
- Product Batch or Serial number.
- Valid signature.
- Valid European Directives and relevant Standards including
current Revisions.
4. The manufacturer or his authorised representative must keep a copy
of the Declaration of Conformity with the technical documentation.
5. Retention of documentation
35.—(1) A responsible
person shall hold an EC declaration of conformity in relation to
relevant apparatus at the disposal of the
Secretary of
State for ten years beginning with the date on which the latest item of
relevant apparatus to be supplied in the
Community to which the
declaration relates was so supplied.
(2) Where the EC declaration of conformity is
made pursuant to Part V or VI of these Regulations, the responsible
person
shall hold the
technical construction file, or EC type-examination certificate, as the
case may be, at the disposal of the
Secretary of
State for ten years beginning with the date on which the latest item of
relevant apparatus to be supplied in the
Community to
which the technical construction file or EC type-examination
certificate relates was so supplied.