Notified body

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Notified bodies , even Notified bodies ( english Notified Bodies ), the European Union are government approved and government-controlled private inspection (Auditier- and Certification Bodies), acting on behalf of the manufacturer, the conformity assessment of manufacturers of industrial products to accompany different types and to control. You are exercising "indirect state administration".

The background to this is that in many areas products may only be sold in EU countries if they meet certain (safety) requirements. In simple cases, the manufacturer certifies that his product meets the requirements ( conformity with the requirements), but often a neutral, competent body must be involved - the Notified Body. State approval is only required in exceptional cases , such as medicinal products .

Notified bodies are neutral and independent organizations that can be nominated by an EU member state if they fall under its sovereignty. Organizations outside the EU can be named by the Commission, for example in Turkey based on Decision 2006/654 / EC . The main task is to carry out the conformity assessment of products of the free movement of goods , provided this is provided for the product in question in accordance with the EU directives , and thus to minimize the risk for users of the tested products.

tasks

In cases in which the involvement of a neutral body is required, notified bodies take on the tasks in connection with the conformity assessment procedures specified in the directives or regulations of the European Union according to the new concept .

They certify the manufacturer and the responsible supervisory authorities of the contracting states of the European Economic Area (EEA)

  • compliance with "basic requirements" for the product properties (such as the design, construction, safety and function), which in turn are specified in the "harmonization guidelines", and
  • compliance with the conformity assessment procedures prescribed by the harmonization directive

and thus entitle the manufacturer to submit the "declaration of conformity" and to affix the CE mark to his product.

The EU member states are responsible for naming the bodies, in Germany the respective ministries 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 the conformity assessment under the conditions specified in the guidelines. This is a service in areas that are of public interest.

As part of their designation, the Notified Bodies are free to offer their conformity assessment services to all economic operators established within or outside the Community. You can carry out these activities in all EU Member States or in third countries.

Manufacturers of products can choose freely between the Notified Bodies, which are designated to carry out the relevant conformity assessment procedure in accordance with the applicable directive.

Notified bodies in Germany can be found, along with many others, for example with DEKRA or the various branches of TÜV .

Naming procedure

Notified bodies are nationally “appointed” to the European Commission in a “designation procedure” after meeting minimum European requirements.

In the "Medical Devices" sector, the Commission Implementing Regulation (EU) No. 920/2013 of September 24, 2013 regulates the designation and supervision of notified bodies in accordance with Council Directive 90/385 / EEC on active implantable medical devices in 2014 of the Council Directive 93/42 / EEC on medical devices the designation procedure.

Notified bodies can, but do not have to be additionally "accredited". However, accreditation makes sense if a notified body is active there as a Conformity Assessment Body (CAB) within the framework of mutual recognition agreements between the EU and third countries . An accreditation can also cover certain requirements for the designation, e.g. B. "Organizational and general requirements" and "Quality management requirements" (Art. 31, Paragraph 2, Clause 2 of the proposal for an EU Medical Device Regulation in conjunction with Annex VI, Sections 1 and 2).

As far as a notified body is to fulfill its legal tasks of a subcontractor, e.g. B. a laboratory, an accreditation of this laboratory also makes sense, because the accreditation makes it easier for the overall responsible Notified Body to prove the suitability of its subcontractor to its national monitoring authority.

The EU member states can designate bodies that are subject to their jurisdiction and that continuously meet the requirements of the directives and the principles laid down in Decision No. 768/2008 / EC .

liability

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

See also

Individual evidence

  1. ↑ List of Notified Bodies in Turkey
  2. ↑ zlg.de accessed on June 18, 2015
  3. ↑ Decision No. 768/2008 / EC of the European Parliament and of the Council of 9 July 2008 on a common legal framework for the marketing of products and to repeal Council Decision 93/465 / EEC . In: Official Journal of the European Union . Series L . No. 218 , August 13, 2008, p. 82–128 ( online at EUR-Lex ).

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