How to get CE Approval

General steps for getting CE Mark Approvals are:

1. Identify all applicable European Directives (laws)

2. Assess your product to the “essential CE approval requirements” contained in the Directives

3. Choose the appropriate assessment path i.e. CE self certification or third party testing

4. Determine the applicable CE certificate standards (international, European, national)

5. If required, perform CE Compliance testing on your product(s) by a “competent body”

6. If you are based outside the EU, get your company an authorized representative in the European Union

7. Prepare a technical file including a users manual

8. Assemble the required CE Mark approvals and CE certificates and a Declaration of Conformity for each applicable Directive

9. Affix the CE Approval Logo in accordance with the laws

Directives and laws

An EU directive is a legislative act of the European Union requiring member states to achieve a particular result. The directive does not dictate the means of getting that result. They are binding on the member states to whom they are addressed. Directives usually leave member states with some leeway as to the exact rules to be adopted.

• The Machinery Directive (98/37 EC)

• The Low Voltage Directive (72/23/EEC)

• The EMC Directive 89/336/EEC, amended by 91/263/EEC, 92/31/EEC, 93/97/EEC.

• The Pressure Equipment Directive (97/23/EC)The ATEX Directive (94/9/EC)

CE Mark

The CE Mark (an acronym for the French “Conformite Europeene” ) certifies that a product has met the health, safety and environmental requirements of the European Union, thereby ensuring consumer and workplace safety.

All manufacturers in the EU and abroad must meet CE mark requirements where applicable in order to market their products in Europe. Once a product has earned the Conformite Europeene Mark, it may be marketed throughout the EU without having to undergo further modifications in each member state. That’s why the CE Mark has been called the “trade passport” for Europe.

EMC Compliance and testing

EMC Directive 89/336/EEC refers to Electro-Magnetic Compatibility. This EU Directive describes the ability of an electrical product to be immune from interference directed to it as well as its ability not to interfere with the operation of other electrical products. If the product satisfies these criteria, then the product is said to be electro-magnetically compatible.

Mechanical design

Lotus Automation provides project leadership and mechanical engineering design support in the planning and execution of new product development, line extensions, and product and manufacturing processes improvements. Our 20 years experience includes product investigation, invention, prototype, design, testing and validation using existing and new technology processes. Our approach is to apply first engineering principles, advanced engineering methods, data and analysis to enhance machine development activities. Our skilled engineers identify, break down and solve complex problems in machine design. Our teams are cross functional and work closely with customers for machine design concepts and input requirements.

Project Management

If you are a machine manufacturer or importer into Ireland/UK/Europe, we can help you with your machine's compliance to the European Machine Safety Regulations.

Consultancy

Our Compliance Management Services was developed through the experience gained during our many Consultancy projects.

Please contact us to see how we can assist you in all your consultancy needs.

Support

We support the following and more..

• CE Marking Technical Files

• Risk Assessment and Hazard Analysis

• Declaration of Conformity

• Authorized Representative

• CE Mark Training

• Pre-Purchase Audits

• Incident Investigations

Technical Files

• The requirements of many of the CE Marking Directives and in particular under the Machinery Directive 98/37/EC, you are required to create a Technical File

• Lotus Automation can compile your Technical Files, enclosing all the relevant documentation.

• We have direct access to many equipment and component manufacturers and suppliers to assist in retrieving their Declaration of Conformity for their parts used in your product or machine.

• Lotus Automation ensures that you can demonstrate compliance to all the essential health & safety requirements set out in the appropriate Directives.

• (To be retained for 10 years by the manufacturer).

• Preparation and submission of CE Technical file(s) and CE Design dossier(s)

• Advice on and evaluation of the Risk Management system

• Advice on and review of the Essential Requirement(s)

• Labeling and language compliance

• Declaration of Conformity

• Expert reports and other technical documentation

We can also provide a Full management and updating service.

Production line Certification

• Lotus Automation offers a scheme to assist major industries who install, modify and maintain small, medium and large scale production facilities.

• Using the Machinery Directive and our skills we appropriately assess almost any combination of machinery, to create a master technical filing system covering the entire line.

• We have successfully CE Marked production lines in many industry sectors, from food processing, brewing and bottling through to large scale industrial production facilities Pharmaceutical and Healthcare sectors.

• Please contact us, and we will be happy to assist you in all your process line assessment needs.