The European new approach
directives require the involvement of third parties in the conformity assessment of
certain products. Traditionally these third parties had been national authorities of the
Member States. However, some Member States had gained good experience in delegating
technical work to non-governmental entities. These non-governmental entities were unknown
to some Member States and to the European Commission. As there were no uniform criteria
for the designation of such entities, the development of European legislation was
relatively difficult.
The new approach reoriented EU legislative policy on such matters as
technical competence, objectivity and transparency as the foundations for the necessary
degree of trust in the system, on the basis of documented technical criteria enshrined in
the legislation itself and in the appropriate European standards (i. e. EN 45000 series).
Member States are invited under all new approach directives to notify the Commission of
those bodies which they consider competent to undertake the responsibilities of Notified
Bodies. A clear distinction shall be made at the national level between the Notified
Bodies who intervene in the pre-market conformity assessment procedures and the national
public authorities (national, regional or local) responsible for the market surveillance
imposed by the directives for products on the market.
Notified Bodies are free to offer their conformity assessment services
for which they are notified to any manufacturer established either inside the EU or in
third countries. They may carry out these activities on the territory of other countries
either with their own personnel or with subcontractors.
At the time of the first notification with respect to a new approach
directive the EU Commission assigns a four digit identification number to the Notified
Body. This number will not change when the same Notified Body is notified for other
directives at a later stage.
Notified Bodies are under surveillance by their national notifying
authorities which have the authority to withdraw or modify the notification as soon as the
conditions of notification are no longer met.
Notified Bodies are and must remain third parties, independent of their
clients and other interested parties.
With respect to the European Medical Devices Directives Notified Bodies
are entitled to perform product as well as quality system management related conformity
assessment procedures as outlined in the respective Articles and Annexes of these
Directives. Notified Bodies may have a limited scope with respect to the device families
and/or the Annexes for which they are notified.
