Notified Bodies are organisations designated by the national governments of the EU member states as being competent to make independent judgments about whether or not a product complies with the essential requirements laid down by each CE marking directive. In order to be Notified, the technical competence and management structure of the organisation must fulfil certain conditions and the name of the body, along with the details of the scope of its notified activities, must be given ('notified') to the European Commission.
These bodies are also the organisations which will be requested to give judgment on the safety of a product by the enforcement authorities in the EU and therefore will be responsible for judging which standards should have been applied to a product and if they have been applied correctly.
Up-to-date contact details for all Notified Bodies, as well as details of their scope of notification, can be found via the European Commission's NANDO database.
Mutual Recognition Agreements
Originally, Member states could only notify bodies within their own territories and so the only bodies which were notified outside of the EEA were subsidiaries of EU resident organisations. However, under the Mutual Recognition Agreements ('MRAs') between the EU and America, Canada, Australia, New Zealand and Japan, regulatory authorities in these countries can, in effect, designate Notified Bodies within their own territory. Further MRAs with countries of the former Soviet Republic, Israel and Asian countries are expected in due course.
It is important to understand that MRAs can only be made for directives for which there is corresponding legislation in each party to the agreement. For example, there can be no MRA between the EU and the USA on machinery because the USA does not have federal legislation which covers the safety of machinery.
The Europa website gives details of MRA's for a variety of countries.
Conformance Ltd. specialises in consultancy and is not a notified body for any of the EU CE mark directives. The requirements for the management structure of Notified Bodies places certain restrictions on the way in which they can provide advice and assistance to clients whose products are being tested by them and we believe that we can offer a better and cheaper service to clients without these restrictions. Where necessary, we provide clients with recommendations on whom they should use as a Notified Body and while we have good working relationships with many, we do not have agency agreements with any. We believe that clients have a right to know that our recommendations are based on our understanding of their best interests, not on some undisclosed financial arrangement between ourselves and the Notified Body. Where we place business with Notified Bodies on behalf of clients, it is our practice to pass the Notified Body fees on at cost to the client, since we make our money by charging for our own expertise, not by selling other people's.