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Conformity assessment and designation of conformity assessment bodies

Designation of Conformity Assessment Bodies (CABs) represents a core function in the operation of the MRA. EU Member States are enabled to designate CABs that will assess and certify products, in specified sectors, which are exported to the third country signatory of an MRA with the EU. The legislation of reference comprises the regulations and technical requirements of the third country. Similarly, third country signatories can designate CABs that in practice will operate as Notified Bodies in the context of the EU internal market.

Council Resolution of 21.12.1989 български (bg) czech (cs) dansk (da) Deutsch (de) eesti (et) ελληνικά (el) español (es) Français (fr) Gaeilge (ga) hrvatski (hr) italiano (it) latviešu (lv) lietuvių (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv) , on a Global Approach to certification and testing, states the guiding principles for Union policy on conformity assessment. The Global Approach was completed by Council Decision 90/683/EEC, which was replaced and brought up to date by Council Decision 93/465/EEC. These Decisions lay down general guidelines and detailed procedures for conformity assessment that are to be used in New Approach directives.

You wish to become a CAB ... then you will need to follow one of the procedures outlined below:

  • if you operate within the EU, follow Procedure (I) 
  • if you operate outside the EU, follow Procedure (II)

Procedure (I) - Designation of CABs by EU Member States

Designation enables European CABs to conduct assessments, in line with the legislation in a non-member country, on products to be placed on the market in that country. It will basically take the form of indicating the details (address, etc.) of the body, the country in question and its legislation, and the detailed technical qualifications - as requested by the third country - on the basis of which the designation is made. An identification number is not assigned to an EU CAB, which may nevertheless already possess identification number as an EU notified body.

The specific requirements that need to be checked for CABs designated by the EU Member States with respect to each MRA have to be listed in the designation dossier - in particular, evidence of the knowledge by the applicant body of the applicable third country legislation/regulations and all other relevant documentation needed to perform certification as indicated in the legislation.

For the purpose of designation, all relevant documentation and information, in line with the requirements of the third country legislation, must be provided - in particular:

(1) Details of the CAB - name, address, contact references;

(2) The criteria used for designation, with evidence and/or certificates providing information on all relevant qualifications (e.g. accreditation);

(3) The scope of designation, with reference to the legislation and the type of products, sectors or standards referred to in the legislation, when appropriate;

(4) The indication of the standards to which the designated body is qualified to test/certify.

This information/documentation will be requested for decision in the Joint Committee.

Procedure

The Member State communicates the dossier pertaining to the applicant CAB, using the appropriate form (designation or renewal of designation) to:

The European Commission
Directorate-General for Enterprise
Unit ENTR/C/1
B-1049 Brussels

Procedure (II) - Designation of CABs by non-EU countries

Designation in this case enables non-EU CABs to assess, in line with EU directives and in accordance with the provisions of the MRA, products to be placed on the EU market. In certain sectors these CABs receive identification numbers (which will feature next to the CE marking where a CAB intervenes during the production phase).

Such designation takes place according to the relevant terms of the MRA - broadly on the basis of the same criteria as for Notified Bodies. In certain sectors, according to the terms of the MRA Framework Agreement and the relevant Sectoral Annexes, these CABs will be performing the same tasks as the EU Notified Bodies. In this case, and in line with the European Commission procedures applicable for Notified bodies, they will be included in the data base of Notified Bodies.

All relevant documentation and information, in line with the requirements of the EU legislation, must be provided - in particular:

(1) Details of the CAB - name, address, contact references;

(2) The criteria used for designation, with evidence and/or certificates providing information on all relevant qualifications (e.g. accreditation);

(3) The scope of designation, with reference to the legislation and the type of products, sectors or standards referred to in the legislation, when appropriate;

(4) The indication of the standards to which the designated body is qualified to test/certify.
This information/documentation will be requested for decision in the Joint Committee.

Procedure

The non-EU country sends the application for a conformity assessment body under the MRA to :

The European Commission
Directorate-General for Trade
Unit TRADE/G/3
B-1049 Brussels

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