A Notified Body is an organization that has been nominated by a member of Government and Notified by the European Commission. A Notified Body will be nominated based on designated requirements, such as knowledge, experience, independence and resources to conduct the conformity assessments.
The primary role of a Notified Body is to provide services for conformity assessment on the conditions set out in the New Approach Directives in support of CE Marking. This normally means assessing the manufacturers conformity to the essential requirements listed in each directive.
Conformity assessment can be inspection, quality assurance, type examination or design examination, or a combination of these. BSI is a Notified Body for 17 European Directives.
Next Steps
For further information about CE Marking for medical devices, please request a quote or contact us.
For further information about CE Marking for all other products, please visit our Global website and request further information.
