Does my product need the CE marking?
Your product must be CE marked if:
- Your product falls within the scope of at least one EU directive/regulation that requires the CE marking
- Your product European Economic Area or Turkey is placed on the market.
- Whether your product is placed on the market or used exclusively by yourself makes no difference
If your product does not fall within the scope of harmonization regulations according to 1., then the CE marking is prohibited.
You simply apply the CE mark and sign the Declaration of Conformity, worry-free
Willy Lebherz
Director & founder of easyCE GmbH
Declaration of conformity done!
Receive your CE declaration of conformity ready for signature.
Risk assessment completed!
CE mandatory risk analysis conducted.
Relevant directives & standards applied!
Your product evaluated against relevant directives and standards.
Technical documentation created!
Receive a pragmatic, user-friendly operating manual.
CE mark attached!
Simply affix the CE mark and you're done.
FAQ
Does my product fall within the scope of a harmonisation regulation?
All products subject to at least one of the harmonisation regulations (EU directive or regulation) may only be placed on the market with CE marking. Currently, there are more than 20 EU directives and regulations requiring the CE marking [3].
Since January 2014, there are actually 25 different EU directives and - regulation requiring CE marking [4]. Simply put, most products fall within the scope of one of these regulations and are therefore subject to labelling. There are vertical regulations that apply to certain product families (for example, toys, pleasure boats, personal protective equipment) and horizontal regulations that more generally regulate certain aspects such as low-voltage devices, explosion-protected area [3].
Do I market my product in the EEA or Turkey?
he CE marking is legally binding in all member states of the European Economic Area and Turkey. The European Economic Area includes the member states of the European Union (EU)
and the member states of the European Free Trade Area (EFTA). These include Switzerland, Liechtenstein, Norway and Iceland. In all other countries of the world, the CE marking is of importance at most within the framework of contractual regulation [4].
In blue the member states of the European Union and in green the EFTA states without Switzerland [5].
Do I market my product or do I use it myself?
The CE marking is of course necessary for products that you sell publicly and offer on the market (put on the market). However, this also applies if your product is only used for personal use [4]
Is CE marking prohibited for my product if none of the above applies?
Therefore, distributors can not choose whether they want the product CE marking or not, but either CE marking is required by product safety law in conjunction with one or more EU directives or if it is not mandatory
it is automatically banned [1]. You expose yourself to at least 4 risks if you do not CE mark your product although this would be necessary or if you are not allowed to CE mark your product. A traffic ban by the supervisory authority is one of the smallest problems here.
Hundreds of companies trust easyCE
With easyCE, product compliance is really 'easy'
Approach to CE marking
Type and manner of support
Scope of support
Contact during project processing
Find the easiest way to obtain the CE mark
Abbreviated process for CE derived directly from CE
All-inclusive or modular – whatever you prefer
Personal contact with experts who take your wishes into account
other CE service providers
Often lacking in sound judgement and unnecessarily complicated
Mostly flexible but often bureaucratic
Mostly flexible in terms of support scope
Mostly personal contact
CE Software
Follows standardised process; special circumstances not taken into account
Double burden for you: software management + no support during processing
Only according to software scope and purchased modules
No contact
You want support that lightens your workload and doesn't create more work.
Reference Projects
CE marking of laboratory machines developed in-house
In the course of an upcoming ISO 45001 occupational health and safety audit, easyCE supported a laboratory technology manufacturer in ensuring CE conformity for its internally used validation machines for medical equipment. Our specialists conducted a comprehensive assessment of occupational health and safety aspects and integrated these into the CE documentation. Particular attention was paid to safe operation by laboratory staff and the documentation of risk assessments that meet both CE and ISO 45001 requirements.
Takes into account, among others: 2006/42/EU, 2014/35/EU, 2014/30/EU, 2011/65/EU EN ISO 12100, EN 60204-1
CE marking for a laboratory robot
In the course of an upcoming ISO 45001 occupational health and safety audit, easyCE supported a medical technology manufacturer in achieving CE conformity for its coagulation robot—a specialized laboratory machine for the automated performance of coagulation cycles for testing purposes. Our specialists conducted a comprehensive assessment of occupational health and safety aspects and integrated these into the CE documentation. Particular attention was paid to the safe handling of electrosurgical components and the documentation of risk assessments that meet both CE and ISO 45001 requirements.
Takes into account, among others: 2006/42/EU, 2014/35/EU, 2014/30/EU, 2011/65/EU, EN ISO 12100, EN 60204-1, etc.
CE marking and consulting for laboratory equipment
In the context of an upcoming ISO 45001 certification, easyCE supported a medical technology manufacturer with the CE documentation for a specialized testing and calibration machine for insufflators in the laboratory sector. Our specialists developed integrated documentation that covers both the CE requirements and the occupational health and safety aspects according to ISO 45001. Particular attention was paid to the safety requirements for handling various hose systems and connections, which can vary depending on the insufflator model.
Takes into account, among others: 2006/42/EU, 2014/35/EU, 2014/30/EU, 2011/65/EU, EN ISO 12100, EN 60204-1 etc.
CE marking for electrical equipment in medical laboratories
As part of the ISO 45001 certification preparation process, easyCE supported a manufacturer of electrical laboratory equipment in the correct classification and CE conformity of its products. Our experts carried out a precise analysis to distinguish between medical devices and electrical equipment in order to ensure correct classification in terms of occupational health and safety. This clarity was crucial for the ISO 45001 requirements regarding hazard identification and risk assessment in the workplace. Successful documentation and conformity assessment enabled the customer to operate its laboratory equipment in full compliance with occupational health and safety guidelines and to pass the ISO audit without any objections.
Takes into account, among others: EN 55032, EN 55035, EN 60335-1 etc.
CE marking for test station for low-pressure units
In the run-up to an ISO 45001 occupational health and safety audit, easyCE supported an industrial company in compiling CE documentation for an internal test bench for low-pressure units in accordance with occupational health and safety regulations. Our experts first analyzed the regulatory classification of the test bench and were able to prove through precise measurements that the Pressure Equipment Directive was not applicable. This clarification was crucial for the correct risk assessment within the framework of the ISO 45001 management system. The CE documentation subsequently created took particular account of occupational health and safety aspects such as operational safety and emergency procedures. This enabled the customer not only to demonstrate CE conformity, but also to pass its ISO 45001 certification without any deviations in the area of work equipment.
Takes into account, among others: 2006/42/EG, EN ISO 12100, EN 60204-1, EN ISO 4414, EN ISO 13849-1 etc.
Learn more about our project references and success stories
Get CE-marking done in 3 simple steps
Step 1
Request expert opinion
Ask for our expert opinion free of charge and find out what is necessary for the CE marking of your product. Be prepared to describe your product in broad terms.
Step 2
Receive our offer
If your product is subject to CE marking, we offer you our support with the CE marking and all accompanying measures. We will be happy to explain necessary steps on the phone.
Step 3
We get it done
When you place an order, you will be assigned your own personal CE expert who will carry out your CE marking and accompany you throughout the entire process. Your expert will also be at your side after the CE marking has been successfully completed.
Get CE-marking done, worry-free
Trust the experts of product safety and conformity
Willy Lebherz - Founder and Managing Director of easyCE
- Expert in product safety and conformity since 1995
- Recipient of the "Medal of the Order of Merit of the Federal Republic of Germany", awarded in 1983 by the then Federal President Carl Carstens
- Master of measurement and control technology
- Captain (ret.), Project Officer for Technical Logistics in the Army Material Office and Chief of the Telecommunications Repair Company
easyCE is a digital, dynamic engineering office with a focus on product safety and product conformity - especially CE-marking. We support manufacturers, operators and dealers in designing products safely and offering them on the market in compliance. We are a "full-service provider" and can take over the entire conformity assessment process for you if you wish. To do this, we support you in carrying out risk assessments, researching standards, product analyses, developing suitable safety precautions, preparing user-friendly technical documentation, coordinating tests and all other accompanying measures. easyCE was founded in southern Germany, but is now active globally.
We know what you need to do to get CE-marking done, worry-free.