CE Marking Process
The CE Marking Process relies on five steps performed accurately and in a timely manner. Technology International is a CE Marking expert that will help ensure that your product carefully completes each step and gets to market faster.
Read on to understand each step you must complete for your product to obtain a CE Marking.
The 5-Step CE Marking Process
Let’s look at the five-step journey a manufacturer will need to take to obtain a CE Marking for their product. To explain how this works in a real-life scenario, we’ll use the example of commercial catering equipment used for processing and cutting vegetables.
Step 1: Determine which EU Directives apply to the equipment
The first step is to identify the applicable legislation. For this, you will need the machine specifications and then determine which of the CE Marking Directives and Regulations apply.
This stage is crucial. If you incorrectly identify the applicable legislation, all the subsequent work becomes invalid. This creates product changes and delays with corresponding financial implications.
The equipment has rotating blades powered by electricity. So, the Machinery Directive (2006/42/EC) is then applicable considering the safety of the equipment. In particular, guarding and operator protection is paramount.
There are no wireless interfaces of any kind (even if they just support data logging and service), so the Radio Equipment Directive (2015/53/EU) is not applicable.
All electrical equipment under the EMC Directive (2014/30/EU) must comply with emissions and immunity requirements, so the EMC Directive is applicable.
Electrical equipment must comply with the RoHS Directive’s substance restrictions (2011/65/EU), which in part ban the use of certain toxic substances.
As the equipment uses an electric motor, there may be Ecodesign (2009/125/EC) requirements. It depends on whether the motor technically falls within the specifics of Regulation 2019/1781.
At this stage, we have identified the necessary CE Marking legislation. All sorts of non-CE legislation may need to be complied with before placing the product on the EU market, such as WEEE, REACH, and Batteries. These are all things that you need to research outside of the CE Marking requirements.
Step 2: Conformity Assessment
This step is critical as it determines how to comply.
The Machinery Directive requires a Risk Assessment, which is done against its Essential Health and Safety Requirements (EHSRs). Since commercial catering equipment is not an unusual type of machinery, there are likely several applicable standards that we could use to support the manufacturer’s claim of meeting the EHSRs. For the Machinery Directive, there are three classes of Harmonised Standard.
- Type-A standards concern the principles of safety and the associated risks. These standards apply to all machines and are almost invariably used.
- Type-B standards cover specific natures of hazards in a broad manner.
- Type-C standards are specific to products.
Typically, most assessments involve using the Type-A Risk Analysis standard in general support of the EHSRs.
In this case of commercial catering equipment, it’s advisable to check for an applicable Type-C standard and, after making a selection, review its coverage against the EHSRs to ensure that all product hazards are addressed. We can address any remaining hazards directly or with the applicable Type-B standards.
The use of standards is not mandatory, but using harmonised standards is the only way to achieve a “presumption of conformity”, the strongest legal position you can get in CE Marking. Beware that selecting the wrong standards could mean the equipment is not deemed safe in its intended environment, and such a setback can cost time and money.
In our example, as food is being processed, there are additional ESHRs regarding contamination, cleaning, materials used, and other hygiene considerations.
For this equipment, we could address the safety aspects by using EN 13870:2015 on the safety of portion-cutting machines, with a risk assessment to EN 12100:2010. There are likely several other standards we could consider to ensure all risks are taken care of correctly. This is significant when a piece of equipment falls within the scope of several standards due to its unique properties and features.
We repeat this process for EMC and other legislation by determining the requirements, limits, and suitable standards. Where possible, product-orientated standards should be used rather than generic—as the product use environment is an essential part of this consideration.
Ideally, all the above is done at the design stage so that the results are “correct as designed” regarding the actual assessment. Usually, this is not the case, especially if the manufacturer has not designed to CE before.
You should address all findings from the assessment so that the equipment and product conforms to the applicable Directives. This is usually the most expensive and time-consuming aspect of achieving CE for the first time.
Most manufacturers prefer to get 3rd party equipment assessment performed unless they are 100% sure about CE. The most cost-effective way is to engage an independent inspection body such as Technology International, an EU-accredited notified body. This is optional but gives an unbiased and independent expert opinion, which an internal team may not be able to provide.
Step 3: Create a Technical File
The law mandates the creation of a technical file. If you cannot produce one in a reasonable time frame when requested by a European Authority, you risk an enforced product recall, amongst other penalties.
The Technical File contains everything the Authorities may need to deconstruct an accident and determine if the equipment was compliant. It includes all technical design information from the point the equipment was put on the European Union market or into service and the compliance assessment information.
You must also produce the instructions in the country’s official language where the equipment will be sold or used.
Step 4: Draft and sign your Declaration of Conformity
The EU Declaration of Conformity can be signed, and the commercial catering equipment obtains an official CE Mark.
Since July 2021, a representative within the EU must be present for the equipment manufacturer. This could be one of the manufacturer’s EU-based companies or a separate entity representing the manufacturer under an Authorized Representative agreement.
Breathe a sigh of relief as the journey has now almost ended.
Step 5: Affix the CE Mark
Getting a CE Marking on the equipment and achieving a suitable compliance level is excellent, but if you are going to make more of the product, you need to ensure at this final stage that all ongoing production remains compliant. A quality management system (QMS) typically incorporates this aspect, which covers the production aspects and anything else that applies to your product.
The QMS must ensure production remains compliant in the face of a changing world. For example:
- Components change
- Suppliers change
- Directives change
- Standards change
- Products change with improvements in cost, features, and specifications
Ensure any changes do not affect product compliance and are signed off by a suitable staff member before being made. Remember that production line tests will continue to be carried out.
It’s also important to analyze and respond to customer feedback about potential safety and other issues. Be prepared to advise the authorities if the product presents a risk.
Lastly, you should formally review the technical documentation periodically while ensuring its security access level is appropriate for your organization. Remember that the authorities may request a copy of your technical documentation.
Helpful Resources
Check out the below resources for more helpful information on CE Marking:
- Does the CE Marking Machinery Directive Apply to My Equipment?
- How Long Does CE Certification Take?
- CE Marking vs. CE Certified? Are These The Same or Different?
- What Impacts the Cost of CE Marking?
Let Technology International Guide You Through the CE Marking Process
Hopefully, this brief CE Marking and compliance description has helped you understand what goes into the CE Marking process. Keep in mind that once you obtain the CE Marking on a product, there is a constant stream of ongoing compliance work that you must maintain to remain compliant.
Partnering with Technology International gives you peace of mind that genuine experts with real-world experience will be with you to steer you through the whole process. We understand that your business drives the CE Marking process as much as your product, and we tailor our support to how you work and your unique situation. We also stand by all our clients for the duration, all 10-plus years. Call us for a no-obligation quote, and see why our clients keep coming back.