Conformity Assessment Modules – Which Certification Path to Choose?

Are you planning to introduce a machine to the European Union market? That’s fantastic! However, one of the most crucial steps lies ahead: the conformity assessment and obtaining the CE mark. This is not just a formality; it’s a confirmation that your machine meets stringent EU safety, health, and environmental standards. This opens doors to free trade across the EU and builds trust among users.

For years, we relied on the Machinery Directive 2006/42/EC. But as the world advances with new technologies, cybersecurity challenges, and the need for more precise regulations, a new EU Regulation 2023/1230 concerning machinery has emerged. This significant change replaces the Directive, introducing directly applicable rules and a refreshed approach to certification.

As a manufacturer, you must understand and choose the right conformity assessment path, which means selecting the appropriate certification module. This is the foundation of success. In this article, we will guide you through the available modules, help you understand their specifics, and show you how to make the best choice to ensure a smooth, legal, and safe certification process for your machines.

CE – Your Passport to Europe!

Think of the CE mark (Conformité Européenne) as a passport for your machine. It’s not just a symbol. It’s your declaration as a manufacturer that the machine has been designed and built according to the essential health and safety requirements applicable throughout the European Union. Without this “passport,” if required, you cannot legally sell your product in the EU. It’s a straightforward path to legal and financial troubles.

The conformity assessment is the entire process in which you prove that you have met these requirements. It’s a responsibility, but also your business card. A machine with a properly assigned CE mark signifies reliability and safety. This builds customer trust and opens doors to European markets.

New Rules: EU Regulation 2023/1230 on Machinery

The European machinery industry is entering a new era. The Machinery Directive 2006/42/EC served us well, but it’s time for changes. From January 20, 2027 (with some provisions already in effect), it will be replaced by Regulation (EU) 2023/1230. What does this mean for us? Primarily, it means that the regulation is directly applicable. It no longer needs to be “translated” into national law. This is great news – everywhere in the EU, we will have the same, uniform rules. No more differences in interpretation!

The new Regulation also places much greater emphasis on machines using artificial intelligence, machine learning, and, importantly, cybersecurity. It introduces detailed requirements in these areas. Many of the basic principles of conformity assessment remain similar to those you know from the previous machinery directive, but their legal basis and some procedural nuances change.

Basics of Conformity Assessment – Your Responsibility as a Manufacturer

As a manufacturer, according to Article 10 of the new Regulation (EU) 2023/1230, you have one clear obligation: conduct a conformity assessment of each machine before even thinking about placing it on the market or putting it into service. This process involves several key steps:

• Conduct a thorough risk assessment: This is the absolute foundation! You must systematically identify all possible hazards associated with your machine – mechanical, electrical, ergonomic, noise, vibrations. Then assess the risk and implement appropriate protective measures. Details can be found in Annex III of the Regulation.
• Meet the essential health and safety requirements (EHSRs): These set the standard. The machine must be designed and built to minimize risk. Annex III of the Regulation is your bible on this topic.
• Prepare solid Technical Documentation (TD): Articles 44 and Annex IV clearly state what it must contain. It’s your proof that the machine meets all the requirements of the Regulation. You must keep it for 10 years from the moment the machine is placed on the market.
• Draft an EU Declaration of Conformity: According to Article 45 and Annex V, you issue a declaration stating that the machine complies with the Regulation.
• Affix the CE mark: End of the process! The machine must have a visible, legible, and durable CE mark (Article 46, Annex VI).

Conformity Assessment Modules in Regulation (EU) 2023/1230 – Which Path to Choose?

Regulation (EU) 2023/1230 provides for various conformity assessment procedures, or modules. The choice of the appropriate module primarily depends on the type of machine, the level of risk, and sometimes… your strategic decision.

The most important division is of machines according to Annex I of the Regulation.

Machines Outside Annex I (“Low Risk”)

• Legally Required Path: For these machines, the only legally required path is Module A: Internal Production Control (Article 26).
  • What does this mean for you? You have full responsibility for the conformity assessment process. You assess conformity based on your technical documentation and compliance with essential machine safety requirements. You are not required to involve a Notified Body.
• Voluntary Path: Despite the lack of obligation, many manufacturers voluntarily choose to involve a Notified Body. Why? To increase customer trust, obtain an independent expert opinion (especially for innovative or complex machines), or optimize internal processes. In such cases, you can choose, for example:
  • Module G: Conformity Based on Unit Verification (Article 29) for individual machines.
  • Utilize the services of a Notified Body for voluntary type examination or verification of parts of the Technical Documentation without going through the entire certification procedure.

Machines from Annex I, Part A (“High Risk – Always Notified Body”)

• Legally Required Path: If your machine is on this list (e.g., certain presses, mobile platforms), you must involve a Notified Body. This is mandatory.
  • Available Modules (Notified Body’s Choice):
    • Module B: EU Type Examination (Article 27) + Module C: Conformity to Type Based on Internal Production Control (Article 28): Ideal for series production, where the notified body assesses the design, and you ensure production compliance with that design.
    • Module G: Conformity Based on Unit Verification (Article 29): If you produce single, unique machines, the notified body checks each unit individually.
    • Module H: Conformity Based on Full Quality Assurance (Article 30): For manufacturers with a comprehensive, certified quality management system covering the entire process from design to testing.

Machines from Annex I, Part B (“High Risk – with Self-Certification Option”)

• Alternative Path (Without Notified Body): You can apply Module A: Internal Production Control (Article 26), BUT ONLY IF you fully apply all relevant harmonized standards that cover all essential health and safety requirements (EHSRs) from Annex III for your machine. If even one standard is not fully applied or there are no appropriate standards for all EHSRs, you cannot take this path.
• Legally Required Path (if you do not fully apply standards): If you do not meet the conditions to use Module A (i.e., you do not fully apply harmonized standards or they do not exist), you must involve a Notified Body and choose one of the modules:
  • Module B + C
  • Module G
  • Module H
• Voluntary Path: Even if you could apply Module A (because you fully apply standards), you can voluntarily choose to involve a Notified Body and one of the modules B+C, G, or H. Such a decision may result from the desire to build trust, the complexity of the machine, market expectations, or internal procedures of your design office.

Conformity Assessment Modules: Role of the Notified Body – Your Independent Verifier

Notified Bodies are independent, accredited institutions authorized by member states to conduct conformity assessments. Their role is invaluable, especially for high-risk machines. They act as a “third party,” objectively verifying whether you meet all safety requirements, which increases trust in your product on the market.

It’s important to remember: the notified body does not bear responsibility for the conformity of your machine – that responsibility always rests with you, the manufacturer. Their task is only to confirm that you have correctly fulfilled your obligations in the conformity assessment process.

Conformity Assessment Modules: Technical Documentation and EU Declaration of Conformity – Your Evidence

Regardless of which certification path you choose, solid and compliant Technical Documentation is the foundation. This collection of information must contain everything that allows the conformity of your machine to be assessed. What should it include? Among other things:

• General description of the machine.
• Drawings and diagrams (electrical, hydraulic, pneumatic).
• Design calculations.
• Results of machine risk assessment.
• Applied harmonized standards.
• Test and examination reports.
• Machine operating instructions.

Once you have a positive conformity assessment, you create the EU Declaration of Conformity (Article 45 of the Regulation). This is a very important legal document! In it, you declare that your machine meets all relevant requirements of the Regulation and other applicable EU regulations (e.g., Low Voltage Directive, EMC, and if the machine is in an explosive atmosphere – ATEX). Remember, the declaration must always be current and available to market surveillance authorities.

CE Mark and What’s Next? Your Responsibility Doesn’t End with the Sale

After successfully completing the entire conformity assessment process and preparing the declaration, you can affix the CE mark on your machine. It must be visible, legible, and durable. But beware! This is not the end of your obligations. Your responsibility for the conformity of the machine lasts throughout its presence on the market. This includes:

• Maintaining up-to-date technical documentation.
• Monitoring machine safety (e.g., reporting any incidents).
• Taking immediate corrective actions if it turns out the machine has any non-conformities.
• If you plan significant machine modernization, you must be prepared to conduct a new conformity assessment and possibly obtain a new CE mark.

Harmonized Standards – Your Ally in Machine Safety

Harmonized standards (for example, those from the series PN-EN ISO 13849-1 or PN-EN ISO 12100) are your allies in the conformity assessment process. While their application is voluntary, they provide you with something very valuable: presumption of conformity. What does this mean? If you comply with all the requirements of the relevant harmonized standards, it is assumed that your machine meets the essential health and safety requirements specified in the Regulation.

This significantly facilitates machine design and machine construction, as well as the preparation of technical documentation. As a result, you shorten your path to market introduction.

Industrial Automation and Safety – New Challenges

In the era of dynamic development of industrial automation and increasingly complex control systems, safety becomes even more important. The new Machinery Regulation places a strong emphasis on machine cybersecurity, protection against unauthorized manipulation, and software reliability. This has a direct impact on the certification process.

Designing and integrating advanced safety systems, such as safety-related control systems (SRP/CS), requires deep knowledge of mechanics, electronics, and software. Only properly designed and implemented systems guarantee achieving the required level of machine safety. In this area, the knowledge and experience of your design office play a key role, capable of combining innovation with strict safety requirements. Companies involved in machine design and construction must stay up-to-date with these changing requirements.

Choosing the right conformity assessment path for a machine in light of Regulation (EU) 2023/1230 is a strategic but also crucial decision. Whether your machine requires mandatory involvement of a notified body or you can conduct self-certification, remember a comprehensive approach. Base it on a reliable risk assessment, prepare precise technical documentation, and ensure you meet all essential health and safety requirements.

The CE mark is not just a “market pass,” but above all a solid guarantee of safety. In the face of increasing legal and technological requirements, it’s worth seeking support. Collaboration with experienced experts can significantly streamline and secure the entire machine certification process. This minimizes the risk of non-compliance and ensures the smooth and legal introduction of your machines to the European market.

FAQ: Conformity Assessment Modules