Step by step to CE marking

CE declaration of conformity

1. Review the EU directives and identify the right ones for your product.

To begin with, ask yourself "what is my product in the light of directives?" and look for answers in the definitions in the directives. For example - the Machinery Directive (MD) 2006/42/EC applies to and defines: machinery, interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, removable mechanical transmission devices, and partly completed machinery.

The Electromagnetic Compatibility Directive (EMC) 2014/30/EC (replacing 2004/108/EC) concerns and defines: ‘equipment’,’ apparatus’,’ fixed installation’ and more. Review these and other directives to determine what your product is and what requirements refers to it. The directives also state what they do not refer to, so you need to check it your product is not listed in the exclusions from the directive.

Reading of the regulations will allow you to become familiar with the scope of application of the directive, exclusions from its application and the essential requirements contained in the directive as well as with the conformity assessment procedures that can be used in the process of proving conformity and CE marking of product.

2. Develop an analysis of the risks related with the use of your product.

It is necessary to perform a risk analysis. The analysis allows the identification of hazards associated with the use of the machine (to specific functions/features) at every stage of its life (from commissioning to utilization) and the introduction of safety measures to reduce hazards to reasonable level. The method of developing the hazard analysis / risk assessment is given in the standard EN ISO 12100:2010 (type C standard which replaced the EN 14121: 2009 standard).

The purpose of risk analysis is reduction of the risk and preventing hazard. Protective measures need to be incorporated where a significant hazard can occur. Protective measures.

3. Select harmonized standards

Lists of harmonized standards (constantly updated can be found on the websites of the European Commission).

The directives only set out the essential requirements that must be met by finished and non-finished products before they are placed on the market or put into service (when own use is considered). The means of achieving conformance with the requirements remains the responsibility of the person placing the product on the market. So you can:

  • Voluntarily apply standards harmonized with the directive related to the product.
  • Choose your own technical solution and prove the product's compliance with the requirements of the directive.

The use of harmonized standards enables presumption of conformity with certain essential requirements of the directive provided that we apply the type C standard to a specific product.

Harmonized standards to Machinery Directive 2006/42/EC

4. Select and perform the appropriate conformity assessment procedure

It is the duty of the person placing the product on the market or putting it into service (according to the machine directive it may be the manufacturer or his authorized representative having address in the EU) to prove the compliance of the product with the essential requirements contained in the directive. There are several possible procedures (so-called modules) marked with letters from A to H (see Regulation of the Minister of Economy on conformity assessment procedures). If the product is subject to several directives allowing different conformity assessment procedures, it is possible to use different procedures demonstrating compliance with each directive separately.

In the case of products that may pose a significant risk (listed in Annex IV of the Machine Directive), it may be necessary to involve a notified body as an independent institution - a participant in the conformity assessment process.

Interesting fact: in the case of the R&TTE Directive 1999/5/EC, you may not agree with the opinion of the notified body and still CE mark your product.

5. Wright the EC declaration of conformity

A declaration of compliance must be attached to each product, stating that the product complies with the relevant essential requirements of each applicable directive.

The declaration together with the relevant technical documentation should be kept for 10 years and presented for the request of authorized market surveillance authorities.

6. Place the CE marking

After processing all the above, the manufacturer or his authorized representative shall apply the CE mark to the product. The design of the mark is strictly defined in the directives.

DO NOT HESITATE TO SEND US AN E-MAIL WITH YOUR QUESTIONS, EVEN IF YOU ARE JUST CONSIDERING A PROJECT. IT COSTS YOU NOTHING.

Machinery Design Office
INBIURO Ltd / UNITED KINGDOM
Companies House registration number: 11950373

Tomasz Sienczak MSc. eng.
mob. UK +44 7427755022 (WhatsApp available)
mob. PL +48 504910343

© Machine Design Services Inbiuro 2019
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