Type examination of machinery - EU type examination under the Machinery Regulation
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Danish Technological Institute is a notified body and performs EU type examination and unit verification of machinery under the Machinery Regulation, so you can CE mark and market your product with confidence that it meets the requirements.
If you manufacture a machine listed in Annex I to the Machinery Regulation (EU) 2023/1230 and you have not applied harmonized standards in full, or if the machine falls under Annex I, Part A, legislation requires that an independent notified body verifies that the machine meets the essential health and safety requirements.
For many manufacturers, this raises a number of questions: What must the technical documentation contain? Is our risk assessment sufficient? How does the actual type examination proceed? And what happens when the Machinery Regulation replaces the current directive?
Danish Technological Institute's certification body, Dancert, is a notified body (Notified Body No. 1073) and performs EU type examination of machinery. We help you navigate the process safely, from initial evaluation of documentation to the issuance of the certificate.
Here you can download our guide to CE marking under the Machinery Directive:
Situations that typically trigger a need for type examination or unit verification
We often meet manufacturers who reach out in one of these situations:
- The machine is listed in Annex I, Part A. The manufacturer must always involve a notified body.
- The machine is listed in Annex I, Part B, and harmonized standards are not fully applied. The manufacturer is aware that type examination or unit verification may be required, but is uncertain about what the process entails.
- Doubt as to whether the machine is covered by Annex I. It can be unclear whether a specific machine type falls within the Annex I categories, especially where the machine or safety system applies self-learning behavior (AI).
- Inadequate technical documentation. The risk assessment, calculations, or design documentation are not at the level expected by a notified body.
- Transition from the Machinery Directive to the Machinery Regulation. The manufacturer is uncertain about what the new regulation changes and whether existing certificates remain valid.
- Market surveillance or authority inquiries. An authority has questioned the product's documentation, and the manufacturer needs to strengthen the foundation.
- New markets or customers require documentation. A customer or market requires that the machine be type-examined by a notified body, even if the manufacturer has previously self-certified its CE marking without involving a notified body.
How Danish Technological Institute helps you
As a notified body, Dancert performs EU type examination and unit verification of machinery in Annex I and issues the certificate that entitles you to CE mark and market the product in the EU. Our services typically include:
- Initial assessment and sparring. We review your starting point and help you assess whether the documentation is ready for formal type examination, or if there are gaps that should be closed first.
- Review of technical documentation. We evaluate the risk assessment, design documentation, calculations, test results, and instruction manual in accordance with the essential requirements.
- Testing of the machine. Where relevant, we carry out physical testing or inspection of a representative sample of the machine.
- Issuance of EU type examination certificate. The certificate documents that the machine meets the essential health and safety requirements and serves as the basis for your CE marking.
- Advisory services on the Machinery Regulation. We help you understand what the transition from the Machinery Directive to the Machinery Regulation means for your product and existing certificates.
Why undergo type examination or unit verification?
An EU type examination or unit verification is a legal requirement for certain machines where the manufacturer does not have a fully certified Module H quality system. But the right partner can make the process more than just a formality:
- Secure market access. An EU type examination certificate from a notified body is your documentation that the machine meets the requirements. Without certification, an Annex I machine may not be CE marked and sold in the EU.
- Strengthened product documentation. The process often reveals gaps in the risk assessment or technical documentation, which the manufacturer then gets the opportunity to close before the product hits the market.
- Peace of mind during market surveillance. If an authority asks questions about your product, you stand stronger with a certificate from a recognized notified body.
- Professional sparring, not just inspection. We do not just review the documentation to find errors. We help you understand the requirements and find the best path to compliance.
- Preparation for the Machinery Regulation. By collaborating with Danish Technological Institute, you simultaneously gain insight into what the upcoming regulation means for your products.
- Impartial and independent evaluation. Danish Technological Institute is a self-owning institution with no commercial interests in how the machine is designed or sold.
From the Machinery Directive to the Machinery Regulation: what is changing?
The Machinery Directive (2006/42/EC) is being replaced by the Machinery Regulation ((EU) 2023/1230), which applies from January 20, 2027.
For manufacturers of Annex I machinery, the transition means, among other things:
- End of self-assessment for certain machines: High-risk machinery (Annex I, Part A) now always requires approval from a notified body.
- Digital instruction manuals: It is now permitted to provide the instruction manual digitally (e.g., via QR code), provided the customer can receive a paper version free of charge upon request.
- Cybersecurity requirements: Machinery must be designed and protected against hacking, ensuring that unauthorized external access cannot lead to hazardous situations.
- Rules for AI and software: The regulation sets new safety requirements for machinery with artificial intelligence, machine learning, and autonomous functions.
- Transitional period for type examination certificates: Existing certificates issued under the old directive remain valid until their expiration date if the manufacturer's GAP analysis shows that the new requirements are not relevant to the machine.
Danish Technological Institute monitors developments closely and already advises manufacturers on how best to prepare for the transition.
Which machines require type examination?
Type examination or unit verification by a notified body is required for machinery listed in Annex I to the Machinery Regulation when the manufacturer has not fully applied harmonized standards or does not have a certified quality assurance system under Module H.
Dancert is accredited to certify the following products:
- A.02: Guards for removable mechanical transmission shafts.
- A.03: Lifts for servicing vehicles.
- A.05: Safety components with fully or partially self-evolving behavior using machine learning/AI approaches ensuring safety functions.
- A.06: Machinery embedding systems with fully or partially self-evolving behavior using machine learning/AI approaches ensuring safety functions.
- B.01.01: Circular saws for working with wood and material with similar physical characteristics or for working with meat, with fixed blade during cutting, having a fixed bed or support with manual feed of the workpiece.
- B.01.02: Circular saws for working with wood and material with similar physical characteristics or for working with meat, with fixed blade during cutting, having a manually operated reciprocating table or carriage.
- B.01.03: Circular saws for working with wood and material with similar physical characteristics or for working with meat, with fixed blade during cutting, having a built-in mechanical feed device for the workpieces, with manual loading and/or unloading.
- B.01.04: Circular saws for working with wood and material with similar physical characteristics or for working with meat, with movable blade during cutting, having a mechanical movement of the blade, with manual loading and/or unloading.
- B.02: Hand-fed surface planing machines for woodworking.
- B.03: Thickness planers having a built-in mechanical feed device, with manual loading and/or unloading for woodworking.
- B.04.01: Band-saws having fixed or movable bed and band-saws having a movable carriage, with manual loading and/or unloading, for working with wood and material with similar physical characteristics or for working with meat.
- B.04.02: Band-saws with blade mounted on a carriage for working with wood and material with similar physical characteristics or for working with meat.
- B.05: Combined machines of the types referred to in points B.01 to B.04 and point B.07 for working with wood and material with similar physical characteristics.
- B.07: Hand-fed vertical spindle moulding machines for working with wood and material with similar physical characteristics.
- B.09: Presses, including press-brakes, for the cold working of metals, with manual loading and/or unloading, whose movable working parts may have a travel exceeding 6 mm and a speed exceeding 30 mm/s.
- B.14: Devices for the lifting of persons or of persons and goods involving a hazard of falling from a vertical height of more than 3 meters.
- B.17: Logic units to ensure safety functions.
Contact us
Do you need to have a machine type-examined, or do you have questions about the process? Contact Danish Technological Institute's specialist and technical lead, Frits Fynbo, for an initial discussion about your product and documentation.
The new Machinery Regulation requires EU type examination of all vehicle lifts from January 2027