Notified Body - Notified Bodies

The Notified Body -NB-

Notified Bodies of the European Union are government-appointed and government-monitored private inspection bodies (auditing and certification bodies) that act on behalf of manufacturers to monitor and control the conformity assessment of manufacturers of their various types of industrial products. They thus exercise "indirect state administration". The background to this is that in many areas products may only be placed on the market or distributed in the states of the EU if they meet certain safety requirements. In simple cases, the manufacturer certifies to himself that his product meets the requirements and thus conforms to standards. The manufacturer then draws up a so-called declaration of conformity. Often, however, a neutral, competent body must be involved - the Notified Body. Only in exceptional cases, such as in the case of medicinal products, is additional state approval required. Notified Bodies are neutral and independent organisations that can be designated by an EU member state if they are subject to its sovereignty. Organisations outside the EU can also be designated by the Commission, such as notified bodies in Turkey on the basis of Decision 2006/654/EC.[1] The main task is to carry out conformity assessment of products in the free movement of goods, if this is provided for the product in question according to EU directives, and thus to minimise the risk for users of the tested products.


Notified Bodies perform the tasks related to the conformity assessment procedures specified in the New Approach directives or regulations of the European Union in cases where the involvement of a neutral body is required. They certify to the manufacturer and the competent surveillance authorities of the contracting states of the European Economic Area (EEA)

  • compliance with the "essential requirements" for product characteristics (e.g. design, construction, safety and function), which are laid down in the "harmonisation directives", as well as compliance with the conformity assessment procedures prescribed in each harmonisation directive.

Furthermore, these bodies thus authorise the manufacturer to issue the "Declaration of Conformity" and to affix the CE marking to his product. The EU member states are responsible for the designation of the bodies, in Germany the respective departmental ministry and the Federal Ministry for Economic Affairs and Energy (BMWi). The main task of a notified body is therefore to provide the services necessary for conformity assessment under the conditions specified in the directives. This is a service in areas of public interest. Within the scope of their designation, Notified Bodies are free to offer their conformity assessment services to any economic operator established inside or outside the Community. They may carry out these activities in any EU Member State or in third countries. Manufacturers of devices are free to choose between the Notified Bodies designated to carry out the relevant conformity assessment procedure according to the applicable directive. Notified Bodies in Germany can be found, among many others, represented for example by the branches of SGS, DEKRA or the various branches of TÜV.

Notification procedure

Notified bodies are "notified" nationally to the European Commission in a "notification procedure" after fulfilling European minimum requirements. In the "medical devices" sector, the Commission Implementing Regulation (EU) No. 920/2013 of 24 September 2013 on the designation and supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices in Council Directive 93/42/EEC concerning medical devices now (2014) regulates the notification procedure.Notified bodies may, but do not have to, be additionally "accredited". However, accreditation is useful if a Notified Body acts as a Conformity Assessment Body (CAB) within the framework of mutual recognition agreements between the EU and third countries. Accreditation can also cover certain requirements for designation, e.g. "organisational and general requirements" and "quality management requirements" (Art. 31 Paragraph 2 Sentence 2 of the proposal for an EU Medical Devices Regulation in conjunction with Annex VI, Sections 1 and 2). Where a Notified Body uses a subcontractor, e.g. a laboratory, to fulfil its statutory tasks, accreditation of this laboratory also makes sense, because accreditation makes it easier for the Notified Body with overall responsibility to demonstrate the suitability of its subcontractor to its national surveillance authority.EU Member States may designate bodies under their jurisdiction that continuously fulfil the requirements of the Directives and the principles laid down in Decision No 768/2008/EC[3].


Notified bodies are liable for the correctness of their assessments within the framework of the applicable technical rules for testing procedures and, in the event of damage, within the framework of national civil law and national criminal law.

See also

  • Central Authority of the Laender for Safety Engineering (ZLS)
  • Central Authority of the Laender for Health Protection with regard to Medicinal Products and Medical Devices (ZLG)

Individual references

  • List of Notified Bodies in Turkey retrieved on 18 June 2015 Decision No. 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products and repealing Council Decision 93/465/EEC. In: Official Journal of the European Union. Series L. No. 218, 13 August 2008, pp. 82-128 (Online at EUR-Lex).

Important internet references

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