From 20 January 2027, six machinery categories can no longer self-declare.
The Machinery Regulation (EU) 2023/1230 applies from 20 January 2027 and replaces Directive 2006/42/EC. For most machines the path stays familiar: build the technical file, run the risk assessment, apply the harmonised standards, CE mark through internal production control. For six high-risk categories the regulation closes the self-declaration door. Those machines must pass conformity assessment involving a notified body, an EU type-examination, before they are placed on the market.
For a manufacturer in China, the Gulf, or anywhere outside the bloc, this is not a form to file. It is a route to plan and conduct, with a notified body, a complete technical file, and operating instructions that hold. Begun late, it becomes the reason a machine waits at the border. Begun in time, it is simply the cost of being marketable. Market surveillance under Regulation (EU) 2019/1020 reads the file either way.
A notified body issues the certificate. We coordinate the route to it.
Examines and certifies
An accredited notified body examines the technical design and issues the EU type-examination certificate. It carries that examination. Only it can issue the certificate. The manufacturer contracts it directly; we help prepare the engagement and never sit in its chair.
Structures and coordinates
We review the manufacturer's technical file against the applicable requirements and deliver a gap list. Where a notified body is required, we coordinate the engagement and the timeline. The manufacturer prepares the technical documentation, the risk assessment and the operating instructions. We are not a testing or certification body, and the product liability stays with the manufacturer, where the law puts it.
Industrial manufacturers who treat a machine as a product to be made marketable, not a shipment to be cleared.
You build machinery outside the EU and intend to place it on the European market, for the first time or at a larger scale.
Your product falls, or may fall, into one of the high-risk categories that lose self-declaration under the 2027 Machinery Regulation.
Your team is preparing the technical file and a notified-body type-examination, and you want an independent gap review and a coordinated timeline before a market surveillance query.
You are a B2B and industrial manufacturer, not a high-volume consumer seller, and you want the conformity route structured and coordinated from the start.
The route to a marketable machine, planned backward from the certificate.
We work the route from the result backward, together with the manufacturer's engineers. Where the manufacturer's technical file shows gaps against the requirements its team has identified. Whether the machine may fall into a high-risk category that triggers mandatory type-examination under the Machinery Regulation (EU) 2023/1230, flagged for confirmation by the manufacturer and its notified body. Where the notified body enters, and on what evidence. The manufacturer keeps design, documentation, risk assessment and operating-instruction responsibility throughout. We carry the structure, the sequence and the coordination.
You receive one clear plan you can act on: the route, the open points in the file, the notified-body engagement and the milestones toward CE marking, with the conditions named openly and never buried. We keep the wider frame in view too, market surveillance Regulation (EU) 2019/1020 and the revised Product Liability Directive (EU) 2024/2853 from 9 December 2026, because conformity and liability now move together.
No legal advice. Where legal assessment is required, we work alongside your counsel.
Where our role begins and ends.
This is built for industrial and machinery manufacturers, not for high-volume consumer sellers. A clear scope protects both sides.
We provide technical, regulatory-organisational and commercial consulting. We do not prepare technical documentation, risk assessments or operating instructions, and we do not act as an expert assessor.
Where a notified body is required, the manufacturer contracts it directly. We prepare the engagement and coordinate the timeline. Legal questions are referred to independent counsel, whom the manufacturer instructs directly.
We are not a testing or certification body. The certificate is issued by the notified body, and the product liability stays with the manufacturer, where the law puts it.
What manufacturers ask before they commit to the route.
What is EU type-examination (Module B) for machinery?
EU type-examination, also called Module B, is the conformity assessment procedure in which a notified body examines the technical design of a machine and verifies that it meets the essential health and safety requirements. Under the Machinery Regulation (EU) 2023/1230 it becomes mandatory for the high-risk categories that can no longer self-declare from 20 January 2027.
When does the EU Machinery Regulation 2023/1230 apply and what changes in 2027?
The Machinery Regulation (EU) 2023/1230 applies from 20 January 2027 and replaces Directive 2006/42/EC. It removes the option of manufacturer self-declaration for six high-risk machinery categories, which must instead pass conformity assessment involving a notified body. Non-EU and global manufacturers placing such machines on the EU market must rebuild their route before that date.
Do I need a notified body to CE mark my machine?
Not always. Most machinery can still be CE marked through internal production control once the technical file and risk assessment are complete. A notified body becomes mandatory only where the regulation requires type-examination, which from 20 January 2027 covers the six high-risk categories named in the Machinery Regulation (EU) 2023/1230.
What is the difference between conformity assessment and certification?
Conformity assessment is the full route a machine travels to demonstrate it meets EU requirements, including risk assessment, technical documentation and, where required, type-examination. Certification is one act within it, the notified body issuing the EU type-examination certificate. Under Seal coordinates the route with the manufacturer. The notified body, and only it, issues the certificate.
Does Under Seal issue the CE certificate or carry product liability?
No. Under Seal is not a testing or certification body. Product liability stays with the manufacturer, where the law puts it, and the notified body is responsible for its examination. We coordinate the conformity route; where a notified body is required, the manufacturer contracts it directly.
What technical documentation does a machine need to enter the EU market?
A machine needs a technical file with risk assessment, design and manufacturing drawings, applied harmonised standards, test reports, the operating instructions, and the EU declaration of conformity. The Machinery Regulation (EU) 2023/1230 also permits digital documentation. The file must stand up to market surveillance under Regulation (EU) 2019/1020 before the machine ships.
