A notified body, in the European Union, is an organisation that has been designated by a Member Stateto assess the conformity of certain products, before being placed on the E.U. market, with the applicable essential technical requirements. These essential requirements are publicised in European Directives or Regulations. A manufacturer can use voluntarily European harmonised standards to demonstrate that a product complies with some (or all) of the EU essential requirements; a Notified Body can use the same harmonised standards to assess the conformity to these essential requirements. Conformity assessment can include inspection and examination of a product, its design, and the manufacturing environment and processes associated with it. For example, a notified body may designate that a medical device conforms to the E.U. Medical Devices Directive, which defines the applicable legislation, including the essential requirements, for medical devices. With this Declaration of Conformity, the manufacturer can label the product with the CE Mark, which is required for distribution and sale in the E.U. Additionally, the E.U. member state accrediting the notified body will then inform the European Commission that the product complies with set standards (or not).
More generally, a notified body is an independent, accredited body which is entitled by an authorized accrediting body. Upon definition of standards and regulations, the accrediting body may allow a notified body to provide verification and certification services. These services are meant to ensure and assess compliance to the previously defined standards and regulations, but also to provide an official certification mark or a declaration of conformity.