Designation of conformity assessment bodies

Government Office of the Capital City Budapest

Metrology and Technical Supervisory Principal Department

Technical Supervisory Department

Address: H-1124 Budapest, Németvölgyi út 37-39.
Phone: +36-1-458-5862

E-mail: mfo--.at.--bfkh.gov.hu

Website: http://www.kormanyhivatal.hu/hu/budapest; https://mkeh.gov.hu/

General information on designation of conformity assessment bodies

Legislations falling within the scope of harmonization or national competence stipulate the control, inspection and certification of compliance with the marketing requirements of certain products in order to protect the safety, life and health of consumers and users and to protect the environment, the safety of property.

A conformity assessment body (CAB) is a body that performs conformity assessment, such as calibration, testing, certification and inspection.

Notified bodies are conformity assessment bodies which have been officially designated by the designating authority to carry out the procedures for conformity assessment within the meaning of applicable Union harmonisation legislation when a third party is required.

Notification is the act of the notifying authority informing the Commission and the other Member States that a CAB has been designated to carry out conformity assessment according to an European Union harmonisation act, and fulfils the requirements relating to notified bodies set out in the Union harmonisation act. ‘The notification of a notified body is sent to the Commission and the other Member States via NANDO, an electronic notification tool, where a list of all notified bodies can be found. This way a designated body becomes a ‘notified body’.

Certain designated bodies are also conformity assessment bodies which have been officially designated by the designating authority to carry out conformity assessment procedures within the meaning of applicable national legislation when a third party is required. These bodies are not notified bodies.

The decision on designation is based on accreditation or an assessment of the documents submitted. Accreditation is the preferred way to assess the technical competence of notified bodies. Only Hungarian legal entities can be designated in Hungary.

The designating authority assesses the conformity of the CAB, whether it is technically competent and capable of carrying out the conformity assessment procedures in question, and whether it can demonstrate the necessary level of independence, impartiality and integrity.

The designating authority is obliged to regularly control the CABs to make sure that staffing and equipment required for designation are available and that the procedural rules and the independence requirements are satisfied. The designated bodies shall submit an annual report on their activities related to their designation and must inform the authority about any changes in the conditions of designation. The authority shall also carry out on-the-spot checks and documentary checks to control the continuous maintenance of competence of CABs.

Government Decree 365/2016. (XI. 29.), 24. § points (d)-(f) designates the Government Office of the Capital City Budapest (BFKH) as the designating authority for the categories listed in Table 1.

A detailed information on the designation procedure is available in the official home page of the Authority.

You can find the list of valid designated bodies here.

Designating and notifying procedure rules are controlled by the following regulations

• Act CXXXIII of 2009 on the Activities of Conformity Assessment Bodies, and the regulations issued for its implementation.
• Government Decree 315/2009. (XII. 28.) on the designation of conformity assessment bodies and the detailed rules for the procedure.
• NFGM Decree 5/2010. (I. 14.) on the special rules for organizations acting in the field of conformity assessment of products regulated by the minister responsible for the conditions for the marketing of products under his responsibility.

Table 1. BFKH designates CABs in accordance with the following legislation