What does putting these standards in this document (The Official Journal of the European Union) do? Does putting them here, for example in the case of ISO 10993-10 (skin irritation), mean that my product must comply? I've got a Customer in the UK that is insisting on evidence that our product (or the material used to mold it) complies with the 10993-10; he is saying that the harmonization of these documents essentially means that they are requirements for the product. My concern would be similar for 14155 & 14971.:notme:

According to http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/index_en.html

"Harmonised standards" are European standards, adopted by CEN, CENELEC or ETSI, following a mandate issued by the European Commission after consultation of Member States. They are developed through an open and transparent process, built on consensus between all interested parties.
Compliance with harmonised standards, of which the reference numbers have been published in the Official Journal and which have been transposed into national standards, provides presumption of conformity to the corresponding essential requirements of the EC directives. Compliance with harmonised standards remains voluntary, and manufacturers are free to choose any other technical solution that provides compliance with the essential requirements. In a number of cases compliance with harmonised standards also increases the options for conformity assessment procedures.
My understanding is that, if you don't use one of the harmonized standards to assure compliance of the product against mandatory requirements of the directive, you must ensure equivalence of the proposed methodology to the harmonized document. In other words, in your case you MUST test the product against skin irritation. If you don't use ISO 10993-10 for the test, whatever other standard you use must be equivalent to ISO 10993-10.

According to http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/index_en.html
My understanding is that, if you don't use one of the harmonized standards to assure compliance of the product against mandatory requirements of the directive, you must ensure equivalence of the proposed methodology to the harmonized document. In other words, in your case you MUST test the product against skin irritation. If you don't use ISO 10993-10 for the test, whatever other standard you use must be equivalent to ISO 10993-10.

By way of another example - In my case we use ASTM standards for our materials. In order to get the CE mark approval for some parts we have have the Notified Body approve a Particular Material Appraisal saying that our use of the ASTM B-16 standard is equivalent to the harmonized standards for Brass.
Which, curiously, are not named on the PMA form.

The introduction to Harmonised Standards states http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/index_en.html -

Harmonised standards" are European standards, adopted by CEN, CENELEC or ETSI, following a mandate issued by the European Commission after consultation of Member States. They are developed through an open and transparent process, built on consensus between all interested parties.

Compliance with harmonised standards, of which the reference numbers have been published in the Official Journal and which have been transposed into national standards, provides presumption of conformity to the corresponding essential requirements of the EC directives. Compliance with harmonised standards remains voluntary, and manufacturers are free to choose any other technical solution that provides compliance with the essential requirements. In a number of cases compliance with harmonised standards also increases the options for conformity assessment procedures.
Where the Commission or the Member States consider that harmonised standards present shortcomings with respect to the essential requirements, the publication of the reference in the Official Journal can, in conformity with the procedures laid down in the directives, be withdrawn by the Commission. In such cases, the harmonised standard will cease to provide a presumption of conformity.