A Notified Body is any certified organisation designated to carry out conformity assessment procedures in cases when a third party is required. Simply said, the Notified Bodies have the authority to approve the techniques and methods used by a manufacturer to produce a product.
However, there are cases when this certification body is called an ‘Inspection Body’ instead of a ‘Notified Body’. For example, an Inspection Body is needed for the CE certification of simple pressure vessels or construction products. Other names that the Notified body can have are, for example, an ‘Approved Body’ or a ‘Testing Laboratory’.
The competence of the Notified Bodies is verified by the Member States. The verification is based on a set of criteria laid down in the applicable Directive in conjunction with the essential requirements and the conformity assessment procedure in question. The competence criteria that each body seeking notification must be able to cover are, as follows:
- Availability of personnel that possess the necessary technical competence to perform the conformity assessment procedure/s required for verifying the products’ compliance with the applicable Directives;
- Availability of proper equipment;
- Capability to maintain professional secrecy;
- Independence and impartiality to those directly or indirectly concerned with the product (e.g. manufacturer, supplier and authorised representative);
- Subscription to civil liability insurance, unless the legal responsibility is covered by the Member State under national law.
Although it is not compulsory, accreditation is usually completed under the EN 45000 series of standards. The latter covers all the different types of Conformity Assessment Bodies mentioned above (e.g. Notified Bodies, Testing Laboratories, Approved Bodies and Inspection Bodies). However, of importance is not how the body calls itself, but how competent it is to carry out independently and impartially the tasks in the specific conformity assessment procedure and have the technical capability to do so.
The EN 45000 series of standards generally consists of rules that define how the organisation, management and technical operation of the notified body shall be conducted. This way, the reliability and capability of the Notified Bodies and any other type of conformity assessment Bodies are ensured.
The European Commission has a list of notified bodies in a system called NANDO, New Approach Notified and Designated Organisations.