CE Certifications
Technical dossiers for industrial machinery
At Enginext, we support manufacturers in obtaining CE Certification, which is legally required for the distribution and commercialization of machines within the European Union.
We handle the preparation of the technical dossier and risk analysis, whether for industrial products, equipment, systems, or machinery, providing our clients with all the necessary documentation to achieve CE Marking.
We can carry out testing activities independently or engage our specialized partners, ensuring everything required for compiling the CE Declaration of Conformity technical dossier is completed.
We operate across all industrial sectors, verifying that machinery is safe and compliant for sale and use.
For CE Certifications, we provide our clients with the following services:
- Technical and regulatory consulting during the design and development phase;
- Machine risk analysis, formalized in a dedicated document to be included in the technical dossier;
- Testing execution, necessary to verify compliance;
- Preparation of the technical dossier, ensuring the correct completion of the CE Declaration of Conformity, which the client must retain and present in case of inspections;
- Coordination of all CE declarations, to be delivered at the time of sale along with the machine and its user and maintenance manual.
What is it?
The CE marking, according to the former Machinery Directive 2006/42/EC of December 29, 2009, now repealed by Regulation EU/2023/1230, is a legally required procedure through which the manufacturer certifies that the product sold in the European market complies with the health and safety requirements set forth by EU directives and regulations.
Article I of the Machinery Directive specifically defines what is classified as “machinery”, including interchangeable equipment, safety components, and lifting accessories, and establishes the essential safety and health protection standards they must meet. Additional articles outline the procedures for compliance assessment.
The manufacturer assumes full civil and criminal liability for their declaration. For this reason, the Declaration of Conformity must be accompanied by supporting documents, including the risk analysis and technical dossier, prepared by accredited certifiers to verify the accuracy of the declaration. The CE Compliance Statement must also be included in the user manual of every sold machine.
For certain high-risk goods (such as machines involved in handling flammable materials), the CE Certification cannot be self-declared by the manufacturer. Instead, it must be issued by Notified Bodies, also known as “Notified Organizations.”
At Enginext, in addition to preparing the technical dossier, we provide our clients with comprehensive technical and regulatory consulting to ensure full compliance with CE certification requirements.
How we can help you
Enginext applies its full expertise to verify the machinery intended for commercialization in the European market, ensuring that it complies with all current regulations and providing clients with guaranteed compliance.
Specifically, we handle:
Evaluation of the correct certification process
The preliminary phase with the client allows us to analyze their needs and recommend the best path to meet them. We carefully assess the type of machinery and the related regulations that must be followed in the European market.
Machinery verification and testing
We ensure that the machine or industrial product meets all safety and health standards required by EU directives, performing all necessary inspections and tests. When needed, we also engage trusted partners to assist in the verification process.
Technical dossier preparation
We compile the technical dossier, which is essential for the manufacturer to issue the CE Declaration of Conformity. This document must be included in the user and maintenance manual of each sold machine and retained as proof in case of inspections.
Who is this service for
- Manufacturing companies operating in various industrial sectors within the European Union that require verified safety support to produce their self-certification;
- Manufacturers of hazardous machinery that, by law, require the assistance of a Notified Body to verify whether the machine complies with CE regulations;
- Converters, upfitters, and startups that have partially or fully modified an existing machine and need CE Certification to sell it in the European market.
Why choose Enginext
The CE Certification service for the industrial sector requires a thorough understanding of EU directives, along with a meticulous and precise certification process.
Here’s how we stand out:
Expertise
Our experience as consultants and certifiers, combined with our extensive network of professionals, enables us to cover the entire regulatory framework for the certification and verification of industrial machines and systems.
Innovation
We stay constantly updated on the latest technological and IT advancements, including cybersecurity and AI. We work on efficiency improvement projects and the integration of artificial intelligence systems.
Flexibility
No project is the same, and each requires a customized consulting approach.
We design and implement tailored operational and management solutions to meet every need and achieve the desired results.
Precision
By nature and professional inclination, we are as passionate as we are precise.
We combine our genuine enthusiasm for our work with the renowned rigor of engineers, ensuring accuracy and reliability.
Frequently asked questions
Which authority issues the CE Certification?
In the industrial sector, CE Certification is not issued by any authority. The manufacturer is responsible for self-declaring that the machine is safe, after consulting with a qualified certification body, and assumes full responsibility for the declaration.
I own a company in India and sell machinery in the European Union. Do I need self-certification even if my company is based outside the EU?
Yes, the document is required if the product is sold within the EU, even if the manufacturer’s headquarters are outside the European Union.
I want to sell machinery in Europe and ensure it complies with regulations. Can I rely on you to obtain CE Certification?
At Enginext, we handle the consulting, verification, and testing of industrial machinery. We do not directly issue CE Certification—that is the responsibility of the manufacturer. However, we provide a technical dossier necessary for self-certification preparation.
I manufacture potentially hazardous machinery. Is a CE self-certification enough?
In this case, self-certification is not sufficient under European law. You must involve certified external bodies, known as Notified Bodies. Our team can coordinate the entire process, engaging these professionals to ensure you obtain the necessary certification within the required timeframe.
Is CE Certification required if I sell in Switzerland?
CE Certification is mandatory only for countries within the European Union. Since Switzerland is not part of the EU, CE marking is not required for sales in this market.
What documents are needed for CE self-certification?
The certification process is based on the technical dossier, which includes risk analysis, verification reports, and test documentation.
I need CE Certification for a loader bucket to be mounted on a tractor. Do I also need to homologate the vehicle?
If the loader bucket is installed on a vehicle operating within a construction site or private area and is transported using other vehicles, such as articulated trucks, homologation is not required. However, if the machine needs to move independently on public roads, then both CE Certification and vehicle registration are necessary.
Do you also create user manuals that include CE self-certification?
No, in this case, you would need to contact a specialized company that exclusively provides this service.
How much does the technical dossier for CE Marking cost?
Costs vary depending on the requested service and the complexity of the project. We provide personalized quotes after an initial preliminary assessment.
Do you have experience with international clients?
Absolutely! We work with national, European, and international clients, ensuring compliance with global regulatory requirements.
How can I request the verification of a machine for CE Certification?
You can simply contact us through the dedicated form, send us an email, or call us during our business hours.
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