Key takeaways:
This article explains what an EC Declaration of Conformity for machinery is and provides a template and a completed example, together with a list of the required information and conformity assessment procedures.
- The EC Declaration of Conformity confirms compliance with the requirements of EU directives, including the Machinery Directive 2006/42/EC, as part of the CE process.
- Required elements of the document: manufacturer’s name and address, product description, reference to the directives and standards, date, and the signature of the authorized person
- The product description should allow unambiguous identification: type, model, serial number, and other identifiers (e.g. production line, robot)
- The harmonized standards applied are indicated, for example EN ISO 12100:2010, EN 60204-1:2018, EN ISO 13849-1:2015
- The conformity assessment procedures discussed were: internal production control, EC type-examination, full quality assurance, and combined variants
EC Declaration of Conformity template: the EC Declaration of Conformity is a fundamental document in the product certification process, especially in the industrial automation sector. It confirms that the product meets the requirements set out in the applicable EU directives, such as the Machinery Directive 2006/42/EC. In this article, we outline the key aspects of preparing a declaration of conformity and provide a detailed template you can use.
What Is an EC Declaration of Conformity?
The EC Declaration of Conformity is a formal statement by the manufacturer that a product complies with all applicable requirements of EU directives. It is a key part of the CE certification process for machinery and must be signed by the responsible person. The declaration must include essential information about the product, its compliance with the relevant standards, and the manufacturer’s details.
Declaration of Conformity Template: Legal Requirements
Under the Machinery Directive 2006/42/EC, every manufacturer placing machinery on the EU market must draw up an EC Declaration of Conformity. In practice, this obligation is closely linked to the manufacturer’s wider compliance responsibilities, including those discussed in the new realities for machine manufacturers under Regulation (EU) 2023/1230. This document must include:
- The manufacturer’s name and address
- A description of the product
- A statement of conformity with the relevant directives and standards
- The date the declaration was issued
- The signature of the authorized person
Declaration of Conformity Template: Key Elements
Manufacturer Information
The manufacturer’s name and full address must be stated clearly so that the responsible entity can be identified without ambiguity. This is particularly important when machinery is placed on the EU market and the declaration forms part of the compliance file.
Product Description
The description should be precise and include the product type, model, serial number, and any other identifiers that allow it to be clearly identified. In industrial automation, this may be, for example, a production line or an industrial robot. It is also good practice to ensure consistency between the declaration and the technical documentation for the machine.
Statement of Conformity
A statement must confirm that the product complies with the relevant EU directives and harmonized standards. For products covered by the Machinery Directive 2006/42/EC, all applied standards must be listed. Where EN ISO 13849-1 applies, the declaration should align with the safety-related control system approach described in EN ISO 13849-1 principles for safe control systems.
Date and Signature
The declaration must include the date of issue and the signature of the person authorized by the manufacturer. It is important that the signature is authentic and legible.
Declaration of Conformity Template:
| Declaration Element | Description |
|---|---|
| Manufacturer’s name and address | ABC Manufacturing LLC, 15 Technologiczna Street, 00-200 Kraków, Poland |
| Product description | Refrigeration unit assembly production line, model LPC-3000 |
| Model, type, serial number | Model: LPC-3000, Type: Assembly line, Serial No.: 789123 |
| EU directives and harmonized standards | Machinery Directive 2006/42/EC, EN ISO 12100:2010, EN 60204-1:2018, EN ISO 13849-1:2015 |
| Date the declaration was issued | 5 August 2024 |
| Signature of the authorized person | Jan Nowak, Technical Director |
XYZ Machines LLC
12 Przemysłowa Street,
00-100 Warsaw, Poland
We declare under our sole responsibility that the following product:
Automatic production line model APL-5000
Model: APL-5000, Type: Production line, Serial No.: 123456
complies with the following directives and standards:
- Machinery Directive 2006/42/EC
- EN ISO 12100:2010 – Risk assessment according to EN ISO 12100
- EN 60204-1:2018 – Safety of machinery — Electrical equipment of machines — Part 1: General requirements
Date the declaration was issued: 5 August 2024
Signature of the authorized person:
Jan Kowalski
Technical Director
XYZ Machines LLC
Declaration of Conformity Template: Conformity Assessment Procedures
Internal Production Control
Internal production control is the simplest conformity assessment procedure and may be used for low-risk products that are not listed in Annex IV of the Machinery Directive 2006/42/EC.
Steps:
- The manufacturer ensures that the product meets the essential health and safety requirements set out in the directives.
- The manufacturer prepares technical documentation including, among other things, drawings, descriptions, test results, and risk analysis.
- The manufacturer issues the EC Declaration of Conformity and affixes the CE marking to the product. At the same time, it is worth checking whether the product identification data also meet the requirements set out for the CE nameplate under Regulation 2023/1230/EU.
EC Type-Examination
EC type-examination is a procedure in which a notified body assesses whether a product prototype complies with the essential requirements. If your case requires third-party involvement, understanding the role of a CE notified body helps clarify how this stage fits into the broader conformity assessment process.
Steps:
- The manufacturer submits an application to a notified body together with the product prototype and technical documentation.
- The notified body carries out tests and assessments to confirm that the prototype complies with the requirements.
- If the product meets the requirements, the notified body issues an EC type-examination certificate.
- The manufacturer applies internal production control to ensure that the products manufactured conform to the approved prototype.
Full Quality Assurance
Full quality assurance is the most comprehensive procedure. It covers the manufacturer’s quality management system and is used for high-risk products. This approach becomes particularly relevant when assessing obligations for particularly hazardous machines under Regulation 2023/1230/EU.
Steps:
- The manufacturer implements a quality management system covering design, production, final inspection, and product testing.
- The manufacturer submits an application to a notified body for assessment of the quality management system.
- The notified body audits the quality management system and assesses whether it complies with the requirements.
- If the quality management system meets the requirements, the notified body issues a certificate approving the quality management system.
- The manufacturer applies the approved quality management system and conducts regular internal audits.
- The notified body carries out regular inspections to ensure that the manufacturer continues to meet the requirements.
EC Type-Examination Procedure Combined with Internal Production Control
This is a combination of two procedures: EC type-examination is used to assess the prototype, while internal production control is used to assess series production.
Steps:
- The manufacturer submits an application to a notified body for EC type-examination.
- The notified body examines the prototype and issues an EC type-examination certificate if the product meets the requirements.
- The manufacturer applies internal production control for series production.
- The manufacturer issues the EC Declaration of Conformity in the prescribed format and affixes the CE marking to the product.
Selecting the Appropriate Procedure
The choice of the appropriate conformity assessment procedure depends on several factors, such as:
- The product category and risk level (whether it is listed in Annex IV of the Machinery Directive 2006/42/EC).
- The complexity of the product and the degree of risk associated with its use.
- The requirements of the relevant EU directives, including the broader changes between Directive 2006/42/EC and Regulation 2023/1230.
The Importance of the EC Declaration of Conformity
Issuing the declaration of conformity in the prescribed format is a key part of ensuring the safety of products placed on the EU market. This is especially important in sectors such as production automation, industrial machine building, and process automation, where compliance with standards and directives is essential for both safety and operational efficiency.
Manufacturers are advised to work closely with design offices, notified bodies, and certification specialists to ensure full compliance with legal requirements. This becomes even more important where machinery is supplied through distribution channels that also involve the role of importers under Regulation (EU) 2023/1230.
As production processes become more automated and regulations continue to evolve, manufacturers need to stay up to date with the latest requirements and standards. In particular, hazard identification and ISO 12100-based hazard identification remain central to demonstrating compliance. This allows companies not only to meet legal obligations but also to strengthen their competitive position in the market.
It is also worth reviewing the Machinery Regulation 2023/1230, which will soon become the main legal instrument governing the machinery market. You may also want to follow how the Machinery Regulation 2023/1230 has evolved over its first year. This document also expands the list of machines that require special treatment in the certification process.
Declaration of Conformity Template
This is the manufacturer’s formal declaration that the product meets the applicable requirements of the EU directives. It is a key element of CE certification for machinery and must be signed by an authorized person.
Under the Machinery Directive 2006/42/EC, a manufacturer placing machinery on the EU market must draw up an EC Declaration of Conformity. This document is required as part of the conformity assessment process before CE marking.
It must include the manufacturer’s name and address, a description of the product (type/model/serial number), a declaration of conformity with the directives and standards, the date of issue, and the signature of an authorized person. The text must specify the applicable directives and harmonized standards (e.g. EN ISO 12100:2010, EN 60204-1:2018).
These include internal production control, EC type-examination, full quality assurance, and the EC type-examination procedure combined with internal production control. The choice of procedure depends, among other things, on the product category and risk, and on whether it is listed in Annex IV of the Machinery Directive 2006/42/EC.
The declaration is signed by a person authorized by the manufacturer. The signature must be genuine and legible and include the document issue date.