CEAUDIT according to ISO 45001 completed!
SUPER "EASY" with our help
You simply apply the CE mark and sign the Declaration of Conformity, worry-free
Willy Lebherz
Director & founder of easyCE GmbH
Conformity Check!
We check your in-house built and modified machines for CE compliance before the audit
Conformity Update!
We bring your existing CE documentation up to date with the latest standards and directives
Gap filling!
We professionally prepare all missing CE documentation for your internal machines
Expert advice!
We answer your critical questions about machine safety in the context of the ISO 45001 audit
Pass the audit!
All done! With your new CE documentation, you will pass the audit without any problems
Options for action: If the audit reveals CE gaps
CE quick check: Determining the need for action
CE-Update
Full CE certification for self-built machines
Our recommendation: Preventive CE strategy
If machines without valid CE documentation were identified during the audit, swift action is required. easyCE offers an efficient CE quick check to determine the actual need for action.
We analyze which of your machines fall under the Machinery Directive and which are subject to other directives. We check machines that have already been labeled for the validity of the existing documentation and identify any necessary additions. This gives you a precise overview of the measures required.
Over 300 CE markings for machines since 2021 and more every day...
Only with easyCE, CE marking is worry-free
Approach to CE marking
Flexibility and concept of support
Scope & scale of support
Contact during project work
Simplified and pragmatic approach to CE marking to ensure compliance
In line with to your needs, our experts will take you along the CE marking journey
You choose our support model: From "One-stop-shop full service", to partial and modular - whatever you prefer
First things you receive your dedicated, personal CE expert who will support you along the entire process
Other CE service providers
Often without a sense of proportion and unnecessarily complicated
Mostly flexible but often bureaucratic
Mostly flexible in the extent of support
Mostly personal contact
CE software
Follows a standardised process that does not take special features into account
Double burden for you: Software administration + no support for processing
Only according to software scope and purchased modules
No contact
We simplify CE-marking not the opposite
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.
We support you with CE marking and all accompanying measures
Frequently asked questions
Which machines require CE marking in the context of an ISO 45001 audit?
As part of an ISO 45001 audit, the CE conformity of all machines covered by the Machinery Directive 2006/42/EC is checked. These include:
- Commercially purchased machines after 1995
- Self-built machines for personal use
- Significantly modified existing machines
- Interlinked machines or systems consisting of several individual machines
Interchangeable equipment that changes the basic function of a machine Exceptions may include simple hand tools, very old machines (pre-1995) without significant modifications, or certain laboratory equipment. However, during an audit, documented justification is expected as to why a machine does not bear the CE marking.
What happens if missing CE documentation is identified during the ISO 45001 audit?
If an auditor finds missing CE documentation, this usually leads to a documented nonconformity. Depending on the severity, this can be:
- Minor non-compliance (e.g., minor documentation deficiencies) that must be corrected by the next audit
- Serious non-compliance (e.g., complete absence of CE marking on high-risk machines), which must be rectified prior to certification
In both cases, you must submit an action plan that shows how and by when you will remedy the deviations. In the case of serious deficiencies, a follow-up audit is often necessary to verify implementation. easyCE supports you in remedying these deviations quickly and efficiently.
Trust the experts of product safety and compliance
Willy Lebherz - Founder and Managing Director of easyCE
- Expert in product safety and compliance, 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. 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 the special features that you need to take into account when CE marking your product and we are happy to help you.