CE marking on railway products

CE Marking is the symbol affixed in a product by the manufacturer in order to legally sell it in the European Union. CE Marking is mandatory for products being affected by European Directives meeting all European requirements for health, safety, performance, railway interoperability and environmental standards being applicable. CE Marking is mandatory in the 28 EU Member States, as well as in Iceland, Norway, and Liechtenstein. CE marking gives access to a market of more than 500 million consumers.

The process to obtain CE Marking on a new product can be complex and expensive, especially the first time the marking process of a product is carried out in a company.

Unlike other certifications, CE marking is not based on the fact that the European organizations will grant the authorization to use CE marking, unlike for example UL certification. This is due to the fact that this mark is not owned by any particular body. The manufacturer is the person in charge of using it in a responsible manner. Also, he/she can self-certify his/her products.

The letters "EC" are the abbreviation of the French phrase "Conformité Européene ", which literally means "European Conformity ": the product complies with the essential requirements of European legislation on health, safety, environmental protection, and railway interoperability.

CE marking of a product allows the withdrawal of any non-compliant product, according to customs authorities and market surveillance. The process of CE Marking is complex, both for new companies and for manufacturers with long experience.

CE MARKING PROCESS in 6 STEPS

Step 1: Analysis of the applicable directives.

The first step is to identify whether or not your product should have the CE marking. Not all products are required to have the CE marking, only products that fall within the scope of at least one of the CE Marking Guidelines. There are more than 20 Directives and Regulations of products that cover a range of products.

Step 2: Compliance with essential requirements

Each Directive has slightly different methods to demonstrate compliance . This generally depends on the classification of the product and its intended use. Each Directive has several "essential requirements" that the product must meet.

The best way to demonstrate that these essential requirements are respected is to comply with the requirements of the harmonised standards. The harmonised standards give presumption of conformity , with the essential requirements of the applicable legislation. However, it should not be forgotten that the use of the standards is generally voluntary. The harmonised rules can be found on the website of the 'official journal' of the European Commission.

Step 3: Conformity assessment procedures

CE Markingprocess is always a self-declaration process. However, a third party may be needed to be involved. This is set out in the 'certification system' and varies according to the Directive. For example, in the case of the Interoperability Directive 2008/57/EC and its TSIs (Technical Specification for Interoperability), certification by a third party is quite common: Notified Body or NoBo.

In order to demonstrate compliance with Technical Specifications for Interoperability, the EC verification procedure must be carried out by a Notified Body (NoBo) of Conformity Assessment Body (CAB).

Step 4: Technical construction file

When all the requirements have been established, it is necessary to have evidence that the product complies with the essential requirements of the Directives. This usually involves some evaluation or testing. This often involves ensuring that the requirements of the applicable harmonised standards, which were identified in step 2, are met.

Step 5: Elaboration of EC Declaration of Conformity

Technical documentation related to the product or range of products must be compiled. This information must cover all aspects of conformity and may include details of the design, development, and manufacture of the product. Technical documentation is also known as the Technical Construction File , in which it is included:

• technical description, drawings, circuit diagrams and photos,
• material list.
• specifications and conformity declarations for critical components and materials used.
• details of any design calculation.
• test reports and evaluations and instructions.

Step 6: CE marking on the product.

When the manufacturer, importer or authorised representative is convinced that his product complies with the Directives being applicable to CE marking, he must complete a Declaration. In most of the Directives this is known as the EU Declaration of Conformity , but there are other terms, such as the Declaration of incorporation of partly completed machinery and the Declaration of performance for construction products.

TECHNICAL DOSSIER

The meaning of placing the CE marking on a product goes beyond simply labelling it with these two letters. Keeping the documentary record of compliance with its obligations in this field, in addition to a legal obligation imposed by the Directives in case it is requested by the Administration in a market control. This is a security measure for the manufacturer. The Technical Construction File is the documentary justification of compliance with the applicable Essential Requirements, and of following the conformity assessment methods admitted for the product. The competent authority may ask the manufacturer or his/her representative for this justification. In most cases, this documentation must be kept for at least 10 years.

Once the product is in production, it must be ensured that the product maintains conformity with all declared on the Directives. The manufacturer's internal procedures must take into account that any change to the product that may affect its conformity with any Directive is under control.

Furthermore, it should not be forgotten that the competent Authorities carry out market surveillance through which inspections can take place.

DIRECTIVES, STANDARDS AND ETIs

A Directive is a legislative act of the European Union . It is, therefore, a mandatory law. It therefore requires Member States to adapt their national laws (transposition) to achieve a result that is harmonised with EU rules in this area.

For example, Electromagnetic Compatibility Directive (2014/30/EU) requires Member States to ensure that electrical and electronic devices comply with certain requirements, such as limits on electromagnetic emissions from equipment to ensure that such equipment does not interfere with radio/ TV and telecommunications, nor with other equipment. The Directive also requires the level of immunity of such equipment and seeks to ensure that such equipment is not affected by external interference.

Determining whether a product is under one or more Directives can be difficult. There is no reference tool or database listing which Directives might be applicable to each product.

In order to comply with the Directives, the new product must undergo a series of tests established in some standards or ETIs. A test plan should be prepared for the new product. In this way, the designer knows the objectives to be met in terms of standards or TSIs. Often, the standards or TSIs are not made explicit in the Directives and the designer must know how to select the most appropriate ones.

There are several ways to select these standards. One of these is to select them from the lists of harmonised standards. A harmonised standard is a technical specification, with non-binding compliance, which has been approved by a European Standardisation Organisation(CEN, CENELEC, etc.).

COMPLIANCE OPTIONS

The applicable generic or product-specific Directive sets out the range of compliance options as follows:

• Self-declaration: The self-declaration route is available for products or machines that do not require a mandatory examination, which is the case for most products and machines. The manufacturer assumes full responsibility for evaluation, testing, documentation, declaration of conformity and application of the CE Marking. The Technical Construction File must be made available on request to the authorities. Please note that this process is an internal self-assessment resulting in the issue of the manufacturer's own declaration of conformity to the CE marking. The buyer may require from the manufacturer a proof or report of compliance with the Directives that he/she declares to be in compliance.

• 3th party checked: Leedeo checked. With an independent specialist company such as Leedeo, manufacturers demonstrate and ensure the diligence and accuracy of the confirmation and certification process, beyond a self-certification.

• Compulsory certification: the EU does not require mandatory certification for most products and machines, although this is the case for many railway products due to their Interoperability conditions. After positive tests, the EU NoBo or Notified Body will issue a "type examination certificate".

Our company is a specialist to provide comprehensive support for the whole procedure of CE marking of railway products. Including service 3rd party checked: Leedeo checked.

At document level, selection of directives and regulations, drafting and execution of tests, compliance with the Railway Interoperability Directive and Technical Specifications for Interoperability (TSIs), as well as interface with NoBo.