How global notified bodies ensure global uniform handling of product documentation
How do the notified bodies ensure a uniform handling of product documentation so that the result is more or less the same regardless of who is chosen on the EU list of notified bodies?
When a manufacturer wants or needs official confirmation that his product complies with the relevant directive, he can request a notified body to examine his product documentation.
But how are the notified bodies aligned such that the outcome of an examination will be practically the same regardless which notified body you chose from the list of notified bodies provided by EU? This is important as the manufacturer cannot just go to another notified body if he does not like the examination result of the first one.
The available set of standards is never complete
Manufacturers lacking applicable standards for particular products has been the case since EU started the new approach where directives set the essential requirements and referenced standards provided the simplest means to comply.
The lack of standards lessened as directives matured, but recur when directives change or technology evolves faster than the standards development can follow suit.
Risk (of non-compliance) assessment
The directives require that the essential requirements are met and the manufacturer is expected to perform a risk of non-compliance assessment demonstrating due diligence.
This may be easy when harmonised standards, HS, providing presumption of conformity apply in full. When such standards are not available of do not fully cover the product in its intended and foreseeable use, then the manufacturer must close the gaps and alleviate the identified risk of non-compliance by other means.
In most cases the directives allow the manufacture to argue compliance based on relevant standards found outside the lists of HS for the directives or a selection of relevant tests to supplement standards, which apply in part.
Obligations of a notified body
The directives and other EU legislation places significant requirements on the community of notified bodies and well as on each notified body individually, regarding procedures, communication, control, impartiality, active maintenance of competency, active participation in alignment activities within the notified body community, etc.
A complete list of notified bodies can be found at EU’s Nando database (New Approach Notified and Designated Organisations), which offers multiple search function to find the notified body for the directive of interest.
In case a notified body must refuse, withdraw, restrict, or suspend a certificate, there are obligations to inform relevant EU and national authorities as well as all other notified bodies.
FORCE Certification A/S
With the merger between DELTA and FORCE Technology, DELTA’s notified body services continue with FORCE Certification A/S.
Our services remain the same, however, the main difference being that the service found under DELTA’s old Notified body number 0199 are reduced, while the continued services are now found under notified body number 0200.
For further information, please contact Senior Specialist Ole Hammer, tel. +45 43 25 15 90.