From Directive to Regulation: What Changes on 20 January 2027
From 20 January 2027, the Machinery Directive (2006/42/EC) is fully replaced by the Machinery Regulation (EU) 2023/1230. The shift from a Directive to a Regulation is not just a change of label. A Directive must be transposed into each member state's national law, which historically produced meaningful differences in interpretation and enforcement across countries. A Regulation applies directly and identically across all 27 member states. Interpretations accepted in Germany will less often be rejected in France — but the room for grace periods and national discretion disappears along with that inconsistency.
In practice, the decisive reference point is when a machine is "placed on the market" in the EU. Any machine first placed on the EU market on or after 20 January 2027 can only be assessed for conformity under the new Regulation. Technical files and EC Declarations of Conformity prepared under the old Directive remain valid only for units placed on the market before that date. Because the trigger is market placement rather than the date of manufacture, units produced in the second half of 2026 but shipped in 2027 will require compliance with the new Regulation.
The scope is broad. It covers not only complete machinery but also partly completed machinery, safety components, interchangeable equipment, chains, ropes and webbing, and removable mechanical transmission devices. Korean equipment makers often conclude that "we only supply part of the line, so this doesn't apply to us." In fact, partly completed machinery simply follows a different track — a Declaration of Incorporation and assembly instructions instead of CE marking — and remains fully within the Regulation's scope.
One more item deserves a review: the EU authorized representative. The new Regulation spells out obligations for manufacturers, importers and distributors individually, and requires non-EU manufacturers to maintain a point of contact inside the EU for technical documentation and authority requests. Check whether your existing agreements with local sales subsidiaries or distributors actually assign this role in writing.
When AI Performs a Safety Function, the Machine Becomes "High-Risk"
For Korean smart manufacturing companies, the single most consequential provision is the Annex I list of high-risk machinery. That list now includes "safety-related software and systems with fully or partially self-evolving behaviour." The clause targets exactly the architecture where a machine learning model continues to learn from field data, causing its decision logic to change after shipment.
Use these examples to judge whether your products fall in scope:
The two decisive questions are "does the AI perform a safety function?" and "does its behaviour change after shipment?" AI used for quality inspection or predictive maintenance is not a safety function and therefore falls outside this clause, while a model whose weights are frozen before shipment is unlikely to qualify as self-evolving.
Once classified as high-risk, self-declaration is no longer available and third-party Notified Body conformity assessment becomes mandatory. This is where the schedule risk really sits. Notified Body assessment typically takes 6 to 12 months, and waiting times are stretching further as applications have concentrated through the second half of 2026. Starting certification after design freeze pushes your launch date out, so the practical fix is to work backwards from the Notified Body submission date and build it into the design schedule itself.
You also need to understand how the EU AI Act now interacts with this. The Digital Omnibus on AI (Regulation (EU) 2026/1744), in force since July 2026, moved the Machinery Regulation from Section A to Section B of AI Act Annex I. As a result, the AI Act's high-risk requirements — risk management, data governance, logging, human oversight — do not apply directly to machinery; the Commission is instead to build them into the Machinery Regulation through a delegated act by 2 August 2028. For now, run certification on the Machinery Regulation track alone, but prepare training-data, logging and human-oversight documentation in anticipation of those AI requirements being added.
Technical Files, Digital Manuals and Cybersecurity: Three Paperwork Traps
First, the depth of risk assessment records. Korean manufacturers have commonly relied on summary-style technical files — a table of hazards with a one-line countermeasure each. The new Regulation requires the entire iterative process to be traceable: hazard identification, applied risk reduction measures, residual risk evaluation and user warnings. This is also among the most common grounds for rejection by Notified Bodies.
Second, digital manuals. The Regulation permits digital delivery of instructions for the first time — with conditions attached. You must provide a paper copy free of charge on request, safety-related information receives special treatment, and the digital manual must remain accessible for ten years after the machine is placed on the market. If a website redesign quietly removes links to legacy model manuals, that alone constitutes non-compliance.
Third, cybersecurity. The Regulation introduces a requirement to protect control systems against corruption. The critical distinction here is that this is a design requirement for the product you ship, not a rule about your own factory's OT security. The target is the PLC and HMI inside the machine you sold, not the firewall in your plant. In practice, use IEC 62443-4-1 (secure development process) and 62443-4-2 (component security requirements) as reference frameworks, and build firmware signing, access control and parameter change logging into the design.
One further provision deserves attention: substantial modification. If a machine is modified in a way that creates a hazard not originally intended, or that existing safety measures can no longer cover, the party performing the modification assumes the full obligations of a manufacturer. Companies importing used equipment for automation retrofits, and system integrators adding AI safety functions to existing lines, are directly exposed. This is a point to revisit in your contractual scope of liability.
Roadmap for the Time Remaining: Where to Start
Only about four months remain until full application — and given Notified Body backlogs, companies that have not yet started should treat the effective deadline as already passed and reprioritise around high-risk products and their inventory strategy.
Stage 1 — Product portfolio screening (1–2 months). Classify every product shipped to the EU as (i) complete machinery, (ii) partly completed machinery, or (iii) a safety component, then determine whether learning-based AI participates in any safety function to establish high-risk status.
Stage 2 — Gap analysis (2–3 months). Compare current technical files against the Regulation clause by clause. Most gaps emerge in three areas: risk assessment records, manual delivery arrangements, and control system security design.
Stage 3 — Technical file rewrite and Notified Body booking. If even one product falls into the high-risk category, submit to a Notified Body immediately, and if certification before 20 January 2027 looks unrealistic, reconsider the market placement timing for that product. With six to twelve months of assessment plus time to respond to findings, the margin is thinner than it looks.
You should also plan an inventory strategy. Units placed on the market just before 20 January 2027 remain valid under the old Directive, so deciding in advance when — and through which legal entity — transitional stock enters the EU can materially reduce the compliance burden.
Cost support is available. The Overseas Certification Acquisition Support Program covers testing, assessment and consulting costs for CE certification at a scale of tens of millions of won per company per year, and the Export Voucher program's international certification menu can also absorb Notified Body fees. Both see applications concentrate around the annual call at the start of the year, so it is worth checking now for any additional 2026 rounds and the early-2027 announcement schedule.
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KITIM supports the full EU Machinery Regulation transition, from product classification through government funding applications. We assess how the Regulation applies to each of your product lines and whether any fall into the high-risk category, rebuild risk assessments and technical files to the new standard, support Notified Body selection and assessment response, and handle applications to the Overseas Certification Acquisition Support Program and Export Voucher scheme — all as one connected process. If you export equipment, automation systems or robots to the EU, even a portfolio screening at this stage will give you a clear picture of the work ahead. Please feel free to get in touch for a consultation.