CE Certification for Machinery: Requirements and Compliance

11 June, 2026

What Is the CE Certificate and What Does It Guarantee?

The CE marking — from the French Conformité Européenne — is the manufacturer's declaration that a product complies with the essential safety, health, and environmental protection requirements established by the applicable European legislation. In the case of industrial machinery, the reference framework has been the Machinery Directive 2006/42/EC, which sets out the criteria that any equipment must meet in order to be marketed and put into service within the European Economic Area.

The CE Certificate (technically, the EU Declaration of Conformity) is not automatically issued by any external body: it is the manufacturer itself who, after carrying out the conformity assessment and preparing a technical file, issues the document and places the marking on the equipment. In cases where the machinery presents high risks, an independent notified body must intervene to validate the process.

One vital clarification: CE marking guarantees that the machine was designed and manufactured in compliance with minimum safety standards at the time it was first placed on the market. It does not guarantee that it continues to comply after years of use, structural modifications, or lack of maintenance.

CE Marking Requirements: What Compliance Demands

For a machine to bear the CE marking, the manufacturer must complete a series of steps that form the core of regulatory compliance:

• Conformity assessment. Determine whether the machine complies with the applicable essential health and safety requirements. Depending on the risk category, this assessment may be carried out by the manufacturer or may require the intervention of a notified body.
• Risk analysis and assessment. Identify the hazards associated with the machine and apply safe design principles to eliminate or reduce them.
• Technical file or documentation. Prepare and retain the documentation that demonstrates conformity. Regulations require it to be available for at least ten years.
• EU Declaration of Conformity. Sign the legal document certifying compliance with the applicable legislation.
• CE marking and identification. Affix the marking visibly on the machine and include product identification information and the manufacturer’s contact details.
• Operating and safety instructions. Supply the equipment with an instruction manual in the language of the Member State where it is marketed.

The New Regulation: From Regulation (EU) 2023/1230 to 2027

The framework is changing, and it is important to understand it. Regulation (EU) 2023/1230 on machinery will replace Directive 2006/42/EC as the general framework from 20 January 2027. It entered into force in July 2023 and provides a transitional period during which manufacturers must adapt their machinery and processes.

Although around 90% of the provisions remain unchanged compared to the previous directive, there are significant developments:

• Greater third-party assessment requirements. For certain high-risk machines, the manufacturer’s self-declaration is no longer sufficient and assessment by a notified body is required.
• Digital documentation. Documentation is permitted in electronic format throughout the equipment’s lifecycle, including manuals.
• Software as a safety component. The regulation recognizes the risks associated with new technologies (artificial intelligence, connectivity) and includes software as a safety component, with cybersecurity requirements.
• Clear definition of “substantial modification.” This is one of the most relevant points for anyone repairing, upgrading, or refurbishing machinery, as discussed below.

An important nuance: the regulatory change does not retroactively require recertification of machines that were already legally placed on the market. Directive 2006/42/EC remains the reference framework for machinery marketed before that date.

CE Certification for Second-Hand Machinery

This is where most doubts arise, because the situation of used equipment is rarely as simple as “it has it or it does not.”

Why Some Used Machines Do Not Have CE Certification

Not all absences of CE marking imply serious illegality. There are several operational reasons:

• Age. The Machinery Directive became effectively applicable in 1995. Equipment manufactured before then was not required to obtain CE marking.
• Loss of documentation. The equipment originally had its certificate, but it has been lost over the years. The physical marking remains valid, but proving it during an inspection without the document can be difficult.
• Substantial modifications. When significant changes affecting safety or essential functionality are made, the original certification becomes invalid. Whoever modifies the machine legally assumes the role of manufacturer and must recertify it. Regulation 2023/1230 precisely defines what constitutes a substantial modification: essentially, any change that alters the level of risk identified in the original assessment.
• Non-EU origin. Some equipment from markets outside the EU never obtained CE marking because it was not intended for the European market.

Resale of Used Equipment: When the Obligation Reappears

It is important to distinguish between two legal dimensions: CE marking regulates commercialization, while equipment already in use is governed, in terms of occupational risk prevention, by national regulations such as Royal Decree 1215/1997 in Spain (on minimum safety and health requirements for the use of work equipment).

In practice, this means:

• If a machine was legally introduced into the EU and has not undergone a substantial modification, its simple resale does not automatically generate a new obligation to issue CE marking.
• The obligation does arise when the machine is imported second-hand from a third country (it is considered “new” for EU market purposes) or when it has been substantially transformed.

What Are the Consequences of Operating Without CE Marking?

The implications of putting into service a machine without the required CE marking are serious and affect both the buyer and the employer using it:

• Legal consequences. The Occupational Risk Prevention Act and Royal Decree 1215/1997 require employers to ensure that work equipment is safe. Operating machinery without the required marking may result in substantial administrative penalties.
• Civil and criminal liability. If an accident occurs involving a machine that does not meet requirements, the owning company faces significant legal exposure, and the absence of certification is a determining factor in establishing negligence.
• Insurance implications. Many insurance policies exclude coverage for incidents involving equipment that does not comply with regulations, potentially leaving the company unprotected against significant compensation claims.

How to Regularize a Machine Without a Certificate

The situation is not necessarily a dead end, but it requires rigor. Depending on the case:

• If the machine predates 1995 and was never required to have CE marking, the buyer must still ensure compliance with the minimum requirements of Royal Decree 1215/1997 before putting it into service, which may involve technical adaptations and a compliance report signed by a qualified technician.
• If the documentation has been lost but the original marking exists, it may be possible to recover it through the manufacturer or its authorized representative; in some cases, a notified body may inspect the equipment and issue documentation certifying its conformity.
• If the equipment has been substantially modified, a new conformity assessment will be required, which, depending on the risk category, may require the intervention of a notified body and a new EU Declaration of Conformity.
• If the machine originates from a non-EU market, the importer assumes the role of manufacturer for regulatory purposes and is responsible for obtaining certification before marketing or putting it into service in Europe.

Checklist: Verify the CE Certificate Before Purchasing

Before finalizing the purchase of used equipment, audit the following documentation points:

• Physical marking. Check that the CE marking plate is present, legible, and includes the manufacturer’s identification details.
• EU Declaration of Conformity. Request the original document. It is the key piece of evidence proving conformity; without it, the physical marking is difficult to support.
• Instruction manual. Verify that the machine is supplied with operating and safety instructions, ideally in Spanish.
• Year of manufacture. Determine whether the equipment was manufactured before or after 1995, as this changes the applicable obligations.
• Modification history. Ask whether the machine has undergone transformations that could be considered substantial and therefore invalidate the original certification.
• Origin. Find out whether the equipment was manufactured for the European market or imported from a third country, as this determines who is responsible for conformity.
• Compliance with Royal Decree 1215/1997. For equipment already in use, confirm that it meets the minimum safety requirements as work equipment.
• Seller’s documentary transparency. Ensure that the seller clearly discloses the real documentary status of the equipment.