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A Notified Body, in the European Union, is an organisation that has been accredited by a Member State to assess whether a product meets certain preordained standards. Assessment can include inspection and examination of a product, its design and manufacture. For example, a Notified Body may designate that a medical device conforms to the EU 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 EU.
EU member states will then inform the European Commission whether a product complies with set standards or not, and the names of bodies will be disclosed.
More generally, a Notified Body is a third-party, accredited body which is entitled by an Accreditation Body. Upon definition of standards and regulations, the Accreditation 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.
For instance, the American Society of Mechanical Engineers (ASME) formulated a certain number of safety standards in its Boiler and Pressure Vessel Code (BPVC) and accredited TÜV Rheinland to provide certification services to guarantee product compliance to the defined safety regulations.
- Lists of notified bodies for various EU directives.
- See the business forms of Notified Bodies and their ultimate owners in France, Germany, Italy, the Netherlands and the UK for various EU directives.
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