Notified Body

A notified body, in the European Union, is an entity that has been accredited by a Member State to assess whether a product to be placed on the market meets certain preordained standards. 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 standards 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.

The notified bodies system used by the European Union has been publicly criticized in some capacity since at least 2008 for issues such as:

Discussion of further expanding coordination groups of notified bodies for different product areas, improving marketing surveillance, and making participation in standardization and coordination activities mandatory began within E.U. member states. However, more criticism would arise out of the Poly Implant Prothèse (PIP) scandal in early 2010, when media revealed that the French manufacturer of silicone gel breast implants had been using unapproved in-house manufactured industrial-grade instead of medical-grade silicone for most of its implants. Investigators also brought criticism down on notified body TÜV Rheinland for issuing a certificate of quality for a production process that didn't include the in-house industrial-grade silicone. However, TÜV stated "its remit was to check the production process, not the content of the silicone."

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