5d

Notified bodies and their subcontractors

Some member states have experienced situations where the nature of the professional relationship
between the subcontractor doing the PCA and the notified body responsible for the assessment has
been unclear to the surveillance authorities. The assessments have been unsatisfactory and some
notified bodies are breaking the rules.

Several places in the Directive it is stated that the notified body shall do the assessment. However,
the main question is to what degree a notified body can subcontract its tasks.

Annex XIV to the RCD refers to the body, its director and the staff responsible for carrying out the
verification tests. According to the annex, they shall not become either involved directly or as
authorized representatives in the design, construction, marketing or maintenance of the said
products. Furthermore, the body and its staff shall carry out the verification tests with the highest
degree of professional integrity and technical competence and shall be free from all pressures and
inducements, particularly financial, which might influence their judgment or the result of the
inspection, especially from persons or groups of persons with an interest in the result of verifications.
It goes on to elaborate in more detail. In point 5 it states that the impartiality of the inspection staff
shall be guaranteed. Their remuneration shall not depend on the number of tests carried out or on
the results of such tests.

The “Guide to the implementation of directives based on the New Approach and the Global
Approach” (The Blue Guide) has under the title “Notified bodies and subcontracting” in section 6.5
guidelines for how subcontracting may be conducted. PCA is not mentioned in this text since PCA is
specific to the RCD, but we assume that subcontracting is allowed with PCA and that the guidelines
for the notified bodies also apply when using PCA. Otherwise one must refer to the text of Annex XIV
of the Directive. That text does not mention subcontracting.

With the assumption that subcontracting is allowed for PCA, it should as a minimum be underscored
that the subcontractors:

 may not do the entire PCA, while the notified body just takes care of the paperwork.
According to the Blue Guide, “A notified body can subcontract strictly limited technical tasks
(such as tests and examinations), as long as these can be defined as substantial and coherent
parts of the technical operation. The notified body cannot under any circumstances
subcontract all of its activities, as that would make the notification meaningless.”
 must satisfy the same requirements mentioned in Annex XIV as the notified body, in its field
of expertise.
 must be subject to auditing (or at least to some control) by relevant authority

Proposal

Member states should within 6 months review their notified bodies with respect to practice in the
area of PCA and make sure that they act consistent with the RCD.