Conformity Assessment of Machinery
Directive 2006/42/EC is the basis of the European legislation regulating the machinery sector of the machine building industry. It provides the normative basis for the harmonization of the essential requirements for health and safety regarding the machinery across the whole European Union.
A basic requirement for the machines to be placed on the European single market is to meet the requirements of the Directive. The participation of a third independent party - notified body is required when machinery falls within the scope of Annex IV.
What does the CTEC service include?
1. CTEC is a notified body with the identification number NB 1871 in the Official Journal of the European Commission for Machinery Directive 2006/42/EC and is authorized by the State Agency for Metrological and Technical Surveillance (SAMTS). It performs conformity assessment of machines within the scope of Annex IV of the Directive under the EC type examination procedure.
Machinery in the scope of Annex IV for which CTEC provides conformity assessment services
2. For machines not covered by Annex IV, the manufacturer must apply the conformity assessment procedure Factory Production Control (Module A) which includes:
- preparation of a technical file;
- take all necessary measures to ensure that the production process ensures compliance with the requirements of the technical file and the Directive;
- issuing an EC declaration of conformity;
- affixing the CE marking in accordance with the applicable requirements of the Directive.
The department for Conformity Assessment of Technical Products within CTEC performs machine assessments outside the Annex IV of Directive 2006/42 / EC at the request of an economic operator and issues a certificate after the machinery has been found to comply with the applicable essential requirements. The conformity assessment process involves performing the necessary tests. In cases where the assignor requests an assessment of the machine technical file, CTEC shall issue a certificate of conformity of the technical file for the established compliance. The certificate in the voluntary area is not mandatory but creates prerequisites for greater trust in the product and provides a significant competitive advantage to the manufacturer.
Basic documents and information
Adopted in the national legislation by:
- Ordinance on essential requirements and machinery conformity assessment, Adopted by Government Decree No. 140 of 19.06.2008, promulgated in SG 61 of 8.07.2008, in force from 29.12.2009, amended in SG 71 of 12.08.2008
- Guide to application of the Machinery Directive 2006/42/EC
- List of harmonised standards, supporting 2006/42/EC Directive
- ЕC type examination procedure
- Technical File
- Principles for use of the Identification Number of CTEC in the Official Journal of the European Union - NB1871
- Procedure applications, complaints and objections
- Changes in the conditions of certification (coming soon...)
- Register with issued certificates (coming soon...)
Whom does the conformity assessment service refer to?The obligation to certify compliance with the requirements of the Directive applies to individuals or organizations who place the machinery on the market for the first time within the European Union and to those who make modifications to the machinery.
Benefits for you
The conformity assessment ensures that your machine is designed and executed in accordance with health and safety requirements;
It makes you confident that the machine meets the requirements of the Machinery Directive;
It provides you with a competitive advantage;
It facilitates the free movement of machinery in the EU and the European Economic Area (EEA)
CTEC Ltd. is authorized by the State Agency for Metrological and Technical Surveillance with permission No. 027-OS from 19.08.2010