Do you require a CE Marking file for your newly developed machine?

Do you need to apply a CE marking, but have no idea what it is, why it matters and how to get started? Is your knowledge of applicable European CE directives non-existent or insufficient? We will gladly explain it to you from scratch!

 

CONTACT US

Why CE Marking?

In the European Union, it is mandatory for manufacturers and importers to comply with the relevant CE directives and regulations. These legal texts stipulate all the essential safety, health and environment requirements. The primary purpose of CE marking is to ensure user safety at all times. Secondly, CE marking levels the playing field in a competitive market by having everyone play by the same rules.

A valid CE marking, well supported by the required documentation, will cover your back in case of any legal action against you. Giving you peace of mind, the label confirms you have marketed your products or machines in a professional and “state-of-the-art” manner.

What is CE Marking?

The CE symbol stands for: Conformité Européenne. Any products introduced to the European market by any manufacturer, producer, designer or importer must bear this marking.

A CE marking involves a lot more than just applying a symbol, however. The CE marking is linked to a technical construction file that proves it is in conformity with the rules and regulations. A CE compliant technical construction file is required to draw up a CE conformity declaration and place the label on your product or machine.

TEN has plenty of expertise in preparing these CE files and associated markings for machinery or complete production lines, medical equipment, electrical appliances and construction products. In other words, we ensure that your machine or product complies with European directives and can therefore be introduced to the European market.

Each product is covered by its unique combination of directives, and each directive in turn has its unique requirements and administrative obligations. Can’t see the wood for the trees anymore? Let TEN be your guide to the other side!

A CE file that demonstrates conformity has other advantages, as well:

  • Analysis of all life stages
  • Clear assessment of the risks of your product
  • CE compliant manual on operation, installation, repair and maintenance
  • A basis for training new employees
  • A foundation for additional documentation like sales folders

What are the benefits of having TEN support you?

1.     Shorter time to market

2.     Certified compliance

3.     Experts at work

4.     Possibility of consultancy

5.     Saving money

Let TEN Agency assist you

Do you lack proper knowledge about CE marking? Are you in the dark about how to tackle a CE file? Why not let TEN Agency assist you with drawing up an accurate and comprehensive file and bringing your product to market safely? Avoid wasting time or money by putting our certified experts to work.

In addition to the globally recognized TÜV NORD certificate, our specialists also boast the ‘CECE - Certified Expert in CE Marking’ title, which is the highest possible qualification in the domain of CE marking.

To obtain this certificate, our experts have already successfully completed the Machinery Directive Incorporating CE marking training. In other words, not only are they up to date with the most important European directive, with a detailed understanding of processes and compliance via the latest standards, this certification also grants them consultancy qualifications.

 

CONTACT US

What can our experts help you with?

TEN can assist you with the creation of your file from scratch, help you submit it to a notified body, and provide follow-up. The client’s expertise is advisable when it comes to performing the tests and listing all the properties and features.

Our experts can assist you with:

  • Understanding and complying with CE marking directives
  • Verification of compliance at the design and production stages
  • Drawing up technical documentation according to CE requirements
  • Declaration of conformity or incorporation
  • The placement and use of the CE label
  • Assessment by notified bodies

TEN’s plan of action

Every product category requires a different approach. Each file requires a specific collaborative approach depending on the information available and the ability of developing certain elements independently.

For this reason, we offer two-tiered CE files: 

Tier 1: Consultancy

The first tier involves a short consultancy process during which one of TEN’s CE specialists maps out the product or machine and / or the existing information. During this process all relevant standards, directives and required information are collected and the status of each component part is named in the TCF = Technical Construction File. This consultancy phase yields a clear checklist with remarks about all the steps that are required to arrive at a comprehensive and complete file. With this information in hand, we can also draw up a clear and correct quotation for completing the file.  

Tier 2: Full CE audit

Using the above consultancy process as a guideline, we then discuss what information is missing and who will handle the tasks. These tasks include:

  • Writing up a technical file
  • Performing calculations
  • Organizing tests
  • Organizing audit by notified body
  • Writing a CE compliant manual
  • CE label and labeling

 During this process, we not only complete the technical file in compliance with all the obligations from the directive / regulation, but we also check whether all essential safety requirements are met. We have all the necessary checklists for this exact purpose. The ultimate goal of this process is to generate a compliant file that legally permits the application of the CE Marking.

In need of a CE file? Need a hand with CE marking? Need a manual that fully complies with the law?

 

CONTACT US