What is CE Marking?
CE Marking is a process by which a manufacturer declares that their product conforms to all essential requirements of the ‘CE Marking’ Directives/Regulations which are applicable to their product.
By CE Marking their product, manufacturers can trade their product anywhere within the extended Single Market in the European Economic Area (EEA).
What are ‘CE Marking’ Directives & Regulations?
There are approximately 25 ‘CE Marking’ Directives/ Regulations which specify health, safety and regulatory requirements for a broad range of products. The Directives/ Regulations were introduced by the European Union to harmonize product legislation requirements between all European countries, to enable free movement of goods between European countries.
Is CE Marking mandatory?
If the description and/or intended use of your product matches the description(s) included in the scope of a ‘CE Marking’ Directive/Regulation, then your product must be CE Marked by law.
If your product does not fall within the scope of any ‘CE Marking’ Directive/ Regulation, then it does not require CE Marking. Furthermore, it is forbidden to CE Mark products which do not fall within the scope of a CE Marking Directive/Regulation.
What European Legislation is applicable to my product if it does not fall into the scope of any ‘CE Marking’ Directive?
The General Product Safety Directive (GPSD) applies to consumer products when no CE Marking Directives/Regulations are applicable. In general, it states that a product is safe if it meets all statutory safety requirements under European or national law.
A product’s compliance requirements are determined by other European Standards, national or international standards, European Commission recommendations, or codes of practice.
What products can Project Engineering assist with CE Marking?
Project Engineering specialise in the CE Marking of machinery and mechanical products. For examples of the sectors we specialise in click here.
How do I know if my product requires CE Marking?
Each ‘CE Marking’ Directive/Regulation has a ‘Scope’ which defines the type of products that fall within the requirements of that directive. Project Engineering can complete a CE Marking Classification Report which will identify the applicable directives, regulations, harmonised standards and clarify the actions required to achieve the CE Mark. If CE Marking is not required, the report will provide an explanation why. This can then be provided to clients/ customers to explain why the product has not been CE Marked.
I have old/ existing machinery and I am concerned about its safety, what can I do?
In the Republic of Ireland old/existing machinery falls into the scope of the Safety, Health and Welfare at Work (General Application) Regulations 2007 Chapter 2 of Part 2: Use of Work Equipment.
Under Regulation 28 (a) it states: “An employer shall ensure that any work equipment provided for use by employees at a place of work complies, as appropriate, with the provisions of any relevant enactment implementing any relevant Directive of the European Communities relating to work equipment with respect to safety and health,”
However, in the guidance on this regulation, it is clarified that “The Regulation does not require employers to change their existing equipment to meet the same standards as new equipment, although these standards can be a source of guidance for dealing with particular problems.”
Project Engineering can complete a Design Risk Assessment of old/ existing machinery to assist with compliance with the requirements of the Safety, Health and Welfare at Work (General Application) Regulations 2007, or similar national regulations, for example PUWER regulations in the UK.
I need to CE Mark structural steel fabrications (EN 1090), can Project Engineering help?
No, unfortunately the route to CE Marking of structural steels is quite different to the type of assessment completed for CE Marking of machinery/mechanical products.
I need to CE Mark an electrical device, can Project Engineering help?
If the electrical device has actuated moving parts and is primarily intended for commercial use (rather than domestic use), Project Engineering should be able to assist.
How do I CE Mark my product?
The CE Marking process consists of the following general steps: Ensure your product conforms with all relevant ‘CE Marking’ Directive/Regulation requirements, determine whether you can assess your product by yourself or if you have to involve a notified body, put together a technical file documenting conformity with all relevant ‘CE Marking’ Directive/Regulations, and draft and sign an EU declaration of conformity for your product.
Some products are subject to several ‘CE Marking’ Directives at the same time. You must make sure that your product complies with all the relevant requirements before affixing the CE marking.
You must be able to produce the technical file for your product and any supporting documentation if it is requested by the competent national authority.
Do I need approval from a Notified Body to achieve CE Marking?
The ‘CE Marking’ Directives applicable to your product will determine if notified body involvement is required, however the involvement of a notified body is not required for many product categories. For example, the vast majority of products which fall into the scope of the Machinery Directive do not require the involvement of a notified body for CE Marking.
Project Engineering can complete a CE Marking Classification Report which will identify the applicable directives and harmonised standards, which in turn will identify any required testing by a notified body.
I have imported a machine from outside the EU (e.g. China or America), can I CE Mark it?
If the machine is not CE Marked by the manufacturer, you can assume the role of manufacturer of the machine and complete the CE Marking process. This course of action will require you to take full responsibility for ensuring the machine conforms to all relevant ‘CE Marking’ Directive/Regulation requirements.
How much is a CE Marking Assessment?
Depending on the product, the requirements of Directives/ Regulations and Standards which apply can vary widely in complexity, therefore it is impossible to have standard pricing for CE Marking Assessments.
For pricing, please send details of your product, including pictures and a description of its makeup and intended use.
How long does it take to complete a CE Marking Assessment for a machine/ mechanical product?
For an average machine/mechanical product, after all information required to complete the assessment has been received, a mechanical product CE Marking Assessment typically takes about 2 weeks. This timeline can vary depending on the complexity of the product/ machine.
I have modified a CE Marked machine, what do I need to do?
After modification of machinery, an assessment of modifications is required to determine if the modifications are so substantial that they in effect create ‘new’ machinery, subject to the Machinery Directive. If the modifications are substantial, then the machinery is considered to be ‘new’ and subject to the Machinery Directive (re-CE Marking). A full Technical File must be assembled incorporating all relevant compliance actions as set out in the Machinery Directive.
If after assessment the modifications are considered not to be substantial, then the persons responsible for the modifications must ensure the modified machinery remains in conformity with the relevant Essential Health & Safety Requirements.
Project Engineering can complete an Assessment of Modifications Report which will include a recommended course of action.
Do I need to CE Mark each machine manufactured or imported?
If you intend to trade a series of identical machines, a single CE Marking Assessment may be suitable for all machines in that series.
It is less likely that a single CE Marking Assessment will be suitable if your machines are similar but not identical, i.e. different sizes, various options/extras available.
Project Engineering can review your machine range and provide a CE Marking solution to ensure all your machinery is CE compliant.
I have created a line of Machines or integrated Machines together; do I need to CE Mark the assembly?
A group of two or more machines arranged together are not necessarily an Assembly of Machinery as defined in the Machinery Directive.
For a group of machines arranged together to be an Assembly of Machinery under the Machinery Directive, all of the following criteria must be fulfilled: the individual machines must be assembled together to carry out a common function (for example to produce a product), the individual machines are functionally linked so that the operation of each individual machine directly effects the operation of other individual machines or the assembly as a whole, and the individual machines have a common control system.
If all the criteria above are met, then the line of Machines or integrated Machines is an Assembly of Machinery, subject to the Machinery Directive. The assembly of machinery must be assessed for compliance with the Machinery Directive & relevant harmonized standards, a full Technical File must be assembled, and the CE Mark must be affixed to the assembly.
I have purchased a machine that has been provided with a Declaration of Incorporation, what do I need to do to achieve the CE Mark?
Machinery supplied with a Declaration of Incorporation is partly completed machinery, and is intended to be incorporated into, or assembled with other machinery/equipment to form complete machinery. The assembly of partly completed machinery and other machinery/equipment, must be assessed for compliance with the Machinery Directive & relevant harmonized standards, a full Technical File must be assembled, and the CE Mark must be affixed to the finished machine.
CE Marking Projects
Projects International automation brand needed a safe cell for testing of robots, manipulators and end-of-arm tools. Needs The client, an international automation brand, is at the forefront of factory automation technology with a wide range of robotic products and end-of-arm systems. To enable safe testing of robot systems the client required a standalone cell with pedestal for securing numerous variations of robotic arms. Approach Project Engineering engaged with the client to gain a full understanding of their requirements and project constraints. After digesting this information, a scope of work was developed for delivery of a CE marked robotic test system
Projects Project Engineering support Somex Automation, one of Irelands leading factory automation providers with CE Marking and machinery safety expertise. Needs Somex Automation are a leading supplier of robotic, automation & test solutions to the pharma and medical device sectors as well as general industry. With a growing business, ever increasing system complexity and the need for detailed system specific safety documentation, Somex were seeking a partner to assist with European Directive & Standard compliance and preparing CE Marking documentation. Approach Project Engineering machinery safety engineers engaged with Somex Automation during the design process of the system, extensively reviewing the