Article 54: the countdown to 14 January 2027 — a preparation checklist for the Machinery Regulation

Article 54 of Regulation (EU) 2023/1230 sets out the timetable that, until now, had been scattered across scattered references throughout the text: the Regulation entered into force twenty days after its publication in the Official Journal of the European Union — that is, in July 2023 — but it will apply in full from 14 January 2027, with a handful of exceptions that have already been enforceable since 2023 and 2024. As of today, there is just over six months left until that full application, and the experience of other regulatory transitions — GDPR, the Medical Device Regulation — shows that companies that begin preparing in advance avoid both the sanction risk under Article 50 and the last-minute bottlenecks with notified bodies overwhelmed by requests.

This article serves as the practical closing piece of our series on the Machinery Regulation: here, in the form of an actionable checklist, we bring together what should be resolved at each stage of the timetable, drawing on the articles we have analysed in depth — definitions (Art. 4), essential requirements (Art. 10), risk assessment (Art. 12), EU Declaration of Conformity (Art. 16), technical documentation (Art. 22), and transitional provisions (Art. 52).

Why do some articles come into effect ahead of general application?

The logic followed by the European legislator is consistent: the articles that come into effect early are, for the most part, those that build the institutional infrastructure needed for the rest of the Regulation to function on the day it applies in full. Articles 26 to 42 govern how a Member State designates and notifies notified bodies; if those articles did not enter into force until January 2027, there would be no notified body qualified to issue certificates under the new framework precisely when companies need them. That is why they come into effect early, in January 2024: they provide a three-year window for the network of notified bodies to become operational before demand surges.

The same applies to Article 6, on the criteria and procedure for amending Annex I — the list of high-risk machinery, which now includes the categories of self-evolving behaviour we analysed in our article on Annex I —: it comes into effect early so that the European Commission can begin assessing, from 2023 and 2024, whether it is necessary to add or move machinery categories before the substantive regime takes full effect. And Article 50(1) on penalties comes into effect early so that Member States have material time to transpose their national penalties regime, as we discussed in our article dedicated to that provision.

Preparation checklist: what to do between July 2026 and January 2027

With six months left until full application, we propose a structured four-phase work plan. Each phase draws on an article of the Regulation that we have already analysed in detail in this series.

1. Phase 1 — Catalogue audit (July–August 2026). Classify each machine model according to its expected placing-on-the-market date (before or after 14 January 2027, under the transitional regime of Art. 52) and according to whether it falls under any Annex I category — in particular, check whether any product line incorporates embedded systems with self-evolving behaviour or safety functions based on machine learning, since those categories require mandatory intervention by a notified body.
2. Phase 2 — Update the risk assessment (August–October 2026). Review the risk assessment methodology under Part B of Annex III, explicitly incorporating the risks arising from behaviour that is "totally or partially self-evolving" and from the interaction between machines operating as an integrated set, as required by the new wording of point 1 of the general principles of Annex III — a direct development of the methodology we already described in our article on Article 12.
3. Phase 3 — Technical documentation and EU Declaration of Conformity (October–November 2026). Update the technical file (Art. 22) to reflect the new requirements of Annex III — including section 1.1.9 on protection against software corruption — and prepare the EU Declaration of Conformity template under Article 16, checking which current harmonised standards you will need to cite.
4. Phase 4 — Certification and final testing (November 2026–January 2027). If your machinery requires intervention by a notified body (Annex I, Part A or Part B), book an appointment well in advance: notified body capacity is limited, and demand has historically concentrated in the final months before a regulatory deadline. Complete CE marking under the practical rules of Article 24 only once all documentation has been finalised.

IgeraIndustria in action: tracking the regulatory countdown

Case study: how a packaging machinery manufacturer got organised

A Valencia-based manufacturer of automated packaging lines — which we'll call EnvaTech, anonymised — began auditing its catalogue of 18 models in January 2026. It found that three of them incorporated a machine-vision module with adaptive classification that could fall within the definition of "partially or totally self-evolving" behaviour under Annex I, Part A. Rather than waiting until 2027, the company contacted a notified body in March 2026 for a preliminary consultation, which allowed it to secure an audit slot in October 2026 — three months before the deadline — avoiding the surge in requests that, according to industry sources, will be concentrated between October 2026 and January 2027. The rest of its catalogue, with no self-evolving functions, follows the internal production control procedure (Module A) without needing a notified body.

Frequently asked questions about Article 54

What is the difference between "entry into force" and "application" in Article 54?

Entry into force is the moment a European rule begins to exist legally — in this case, twenty days after its publication in the OJEU, in July 2023. Application is the moment its specific obligations become enforceable for those addressed by it — manufacturers, importers, distributors. Article 54 sets general application at 14 January 2027, with the exceptions already noted for certain articles that apply earlier.

If my machinery already complies with Directive 2006/42/EC, do I need to do anything before January 2027?

It depends on whether you will keep placing new models on the market after that date. If your current stock has already been placed on the market and only remains to be sold, the transitional regime under Article 52 protects you. But if you will continue manufacturing and placing that model — or an evolved version of it — on the market after 14 January 2027, you need to adapt the technical documentation, risk assessment and Declaration of Conformity to the new Regulation before that date.

Can notified bodies already certify under the new Regulation?

Yes. Since Articles 26 to 42 on notification and notified bodies apply from 14 January 2024, the network of notified bodies under the new framework has been operational since that date, giving companies a window of approximately three years to complete their certifications before general application.

What happens if my machine is not ready by 14 January 2027?

If your machine does not have a valid EU Declaration of Conformity, a complete technical file and CE marking compliant with the new Regulation at the time you intend to place it on the market for the first time after that date, you will not be able to lawfully market it in the EU or the EEA until you correct those shortcomings. In addition, you will be exposed to the penalties regime under Article 50 and to the market surveillance corrective measures under Articles 43 and 45.

Should I wait for Spain to publish its transposition legislation before starting to prepare?

No. Regulation (EU) 2023/1230 is directly applicable throughout the Union, with no need for transposition of its technical and substantive content — unlike a directive. Only the penalties regime under Article 50 requires national development. Waiting for that transposition before starting to adapt the technical file or the risk assessment is, simply, wasting time you don't have to spare.

What should an SME with limited budget prioritise?

With limited resources, the priority should be: first, identify whether any product falls under the high-risk categories of Annex I (because that determines whether you need a notified body, the slowest and most costly part of the process); second, update the risk assessment under Annex III; and third, review the EU Declaration of Conformity and the technical file. Products with no special risk can follow the internal production control procedure, which is considerably faster.

Sources: Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery (OJEU L 165, 29.6.2023), Article 54 and Articles 6, 26-42, 47, 48, 50, 52 and 53; Directive 2006/42/EC (repealed with effect from 14.1.2027). This article is for informational purposes only and does not constitute legal or engineering advice.