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Conformity Assessment

Conformity assessment is the process carried out by a manufacturer to demonstrate whether specific requirements relating to a product have been fulfilled.

In the EU legislation, conformity assessment procedures, called also “modules”, cover both design and production phases of a product.

The main reference document on conformity assessment is Decision 768/2008/EC, which, besides setting down the rules for the EC marking of products, lays down the modules that can be used for all regulated sectors. The specific nature of the railway sector requires a specific set of “modules” implementing the generic provisions of Decision 768/2008/EC. This set of specific modules are defined in Decision 2010/713/EU.

Most railway specific modules require a third-party independent conformity assessment performed by bodies notified by Member States to the European Commission. These bodies are known as Notified Bodies (NoBos).

The European Commission has established the NB-RAIL Coordination Group to ensure appropriate coordination and cooperation between NoBos.

ERA supports the activities of the NoBos and actively participates to the activities of NB-RAIL.

Furthermore, ERA is also tasked with monitoring NoBos and, for this purpose, has developed an assessment scheme which details the requirements against which NoBos can be assessed. This monitoring system for NoBos supports the activities already carried out by each Member State.

Point 5.2.3 of the abovementioned ERA assessment scheme requires that ‘ERA shall be included in the list of bodies to which the mechanism to safeguard impartiality shall address communication of independent actions undertaken’: mechanisms to safeguard impartiality shall use the NOBOs Monitoring topic on the Contact us form to ensure that this information is provided to the Agency.

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Related documents

Decision of the executive Director of the ERA, adopting the Technical Document 000MRA1044 ver. 2.0 providing requirements for conformity assessment bodies seeking notification and making further provisions for audits and inspections

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DECISION n°156 of the Management Board of the European Union Agency for Railways adopting the provisions on auditing notified conformity assessment bodies in the framework of Article 34 § 3 of Regulation (EU) 20

English (136.67 KB - PDF)
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Annex_ Provisions on auditing notified conformity assessment bodies in the framework of Article 34 § 3 of the Agency Regulation

English (173.78 KB - PDF)
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Technical Document Requirements for NoBos ver 2.0

English (759.84 KB - PDF)
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Technical Document Requirements for NoBos ver 1.1

English (1.01 MB - PDF)
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ERA1209-186 Clarification Note on the acceptance by a NoBo of the results of an independent assessment carried out by an AsBo

English (956.69 KB - PDF)
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