Notified Body
Encyclopedia
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.
European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
, is an organisation that has been accredited by a Member State
Member State of the European Union
A member state of the European Union is a state that is party to treaties of the European Union and has thereby undertaken the privileges and obligations that EU membership entails. Unlike membership of an international organisation, being an EU member state places a country under binding laws in...
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
Medical device
A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...
conforms to the EU Medical Devices Directive
Medical Devices Directive
The Medical Device Directive is intended to harmonise the laws relating to medical devices within the European Union...
, which defines the standards for medical devices. With this Declaration of Conformity, the manufacturer can label the product with the CE Mark
CE mark
CE marking is a mandatory conformity mark for products placed on the market in the European Economic Area . With the CE marking on a product the manufacturer ensures that the product conforms with the essential requirements of the applicable EC directives...
, 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.