Notified body

CE Mark

A notified body, in the European Union, is an organisation that has been designated by a member state to assess the conformity of certain products, before being placed on the EU 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; alternatively, a notified body 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 essential requirements of the Medical Devices Regulation (MDR (EU) 2017/745) which defines the applicable legislation, including the general safety and performance requirements, for medical devices. With this type examination certificate, (and ensuring the product also satisfies all other applicable regulations), the manufacturer can generate its declaration of conformity and label the product with the CE Mark, which is required for distribution and sale in the EU. Additionally, the EU member state accrediting the notified body will then inform the European Commission that the product complies with the essential requirements (or not).[1][2][3]

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 regulations, but also to provide an official certification mark or a declaration of conformity.[4][5]

  1. ^ The 'Blue Guide' on the Implementation of EU Product Rules (PDF) (1.1 ed.). European Commission. 15 July 2015. p. 134. Retrieved 25 February 2016.
  2. ^ "Notified bodies". Growth: Internal Market, Industry, Entrepreneurship and SMEs. European Commission. 11 February 2016. Retrieved 25 February 2016.
  3. ^ Rudd-Clarke, P.; Page, F. (9 December 2015). "A product of our times". Insider Quarterly (Winter 2015). Archived from the original on 25 February 2016. Retrieved 25 February 2016.
  4. ^ Medicines and Healthcare Products Regulatory Agency (November 2013). "Guidance on Legislation: Requirements for UK Notified Bodies" (PDF). Government of the U.K. p. 14. Retrieved 25 February 2016.
  5. ^ Standards Office of the General Cooperation Council for the Arab States of the Gulf (26 November 2008). "Guide for Notified Bodies" (PDF). GCC Standardization Organization - GSO. p. 12. Archived from the original (PDF) on 1 April 2015. Retrieved 25 February 2016.