Notified Body

Notified Bodies (English Notified Bodies ) of the European Union are defined as follows 20 MPG in § 3 No.:

" Notified Body is provided for conducting audits and issue certificates relating to conformity assessment procedures provided for in the ordinance pursuant to § 37 paragraph 1 point, the Commission of the European Union and the States parties to the Agreement on the European Economic Area by a Contracting State of the has been named the Agreement on the European Economic Area. "

They are neutral and independent organizations, which may be identified by an EU Member State, if they fall under its sovereignty. Organizations outside the EU can be named on the Directive 2006/654/EC of the Commission, for example, in Turkey. Main task is to carry out the conformity assessment of products of the free movement of goods, where this is provided for the product in accordance with the EU directives.

Tasks

The European Commission defines the " Guide to the implementation of directives based on the New Approach and the Global Approach" (Section 6.1 " principles for designating ", as of 2000, zz in revision. ) The role of Notified Bodies as follows:

"Notified bodies shall carry in the cases in which the involvement of a neutral body is required, the. In the guidelines under the new approach tasks mentioned in connection with the conformity assessment procedures "

Notified bodies are according to the specifications

> DIN EN ISO / IEC 17000 (March 2005) and

> The relevant Annexes in each sectoral EU harmonization directives

Nationally designated and monitored " auditing and certification bodies ".

You certify that the manufacturer and the competent supervisory authorities of the Contracting States of the European Economic Area ( EEA):

> Compliance with " essential requirements " on product quality ( eg in the interpretation, construction, safety and function), which in turn are defined in the " harmonization directives ", and

> Compliance with the prescribed depending on the harmonization directive conformity assessment procedure and so entitle the manufacturer to submit the " Declaration of Conformity" and to affix the CE marking to his product.

Responsible for the designation of bodies are the EU Member States, in Germany: the respective competent ministry and the BMWi.

The main task of a Notified Body, therefore, is to provide the information necessary for conformity assessment services under the conditions specified in the guidelines. This is a service in areas that are of public interest.

The Notified Bodies are free as part of their designation to offer their conformity assessment services all within or outside the Community established economic actors. You can perform such activities in all EU Member States or in third countries.

Manufacturers of products are free to choose between the Notified Bodies that are appointed to carry out the relevant conformity assessment procedure in accordance with the applicable directive.

Designation process

Appointments take place - as Accreditations - national, that is, according to national ( Accreditation ) Rules (this is the German accreditation body or DKD in Germany ), are mutually recognized by national accreditation bodies of the EU.

Notified bodies are " called" to a " naming process " after meeting European minimum requirements towards the European Commission nationally. They can, but they need not be additionally " accredited ".

An accreditation does however make sense if a Notified Body in the framework of the EU mutual recognition agreements with third countries shall act as " Conformity Assessment Body" (CAB ) there. Also, an accreditation to cover certain conditions for the appointment with, such as " organizational and general requirements " and " requirements of the quality management " (Article 31, paragraph 2, sentence 2 of the proposal for an EU Medical Device Regulation in conjunction m. Annex VI, sections 1 and 2).

To the extent that a notified body to carry out its statutory duties of a subcontractor, such as a laboratory operated an accreditation for the laboratory also makes sense, as the accreditation makes the principal responsible Notified Body to demonstrate the suitability of its subcontractor against their national supervisory authority.

The EU Member States may designate bodies under their jurisdiction and who meet the requirements of the directives and laid down in Decision No 768/2008/EC principles continuously.

The Commission may designate appropriate organizations in accordance with Directive 2006/654/EC located outside the EU but also.

In Germany, since 1 January 2010 under the Law on the Accreditation Body ( AkkStelleG ) of 31 July 2009 ( Federal Law Gazette I p 2625 ) in connection with the AkkStelleG - lending regulation for all accreditations, as well as for the accreditation of Notified Make only the German accreditation Service ( DKD ) is responsible. The AkkStelleG serves the national implementation of Chapter II ( " accreditation " Articles 3 to 14 ) of Regulation ( EC) No 765 /2008.

Based on an assessment of the bodies to the designation body will decide whether it is technically competent and able to carry out the conformity assessment procedure, and whether it has the necessary independence, impartiality and integrity. In addition, the competence of the notified body should be regularly monitored according to established procedures of the accreditation bodies.