From Machinery Directive to Machinery Regulation
A hard cutover on 20 January 2027, and most of your existing work survives it. The essential health and safety requirements are recognisably the same family. What changes is the legal instrument, the high-risk list, the digital requirements, and the paperwork that cites them. Plan an update project, not a rebuild.
Side by side
| Directive 2006/42/EC | Regulation (EU) 2023/1230 | |
|---|---|---|
| Legal form | Directive — transposed into national law by each Member State | Regulation — directly applicable, identical everywhere |
| Scope terms | Machinery, partly completed machinery, interchangeable equipment, safety components, lifting accessories, chains ropes and webbing, removable mechanical transmission devices — listed separately | Machinery and "related products", a single defined set; partly completed machinery still separate |
| High-risk list | Annex IV | Annex I, split into Part A (notified body mandatory) and Part B (self-assessment with standards) |
| EHSRs | Annex I | Annex III — restructured, with new digital, cybersecurity and machine-learning provisions |
| Technical file | Annex VII | Annex IV, Parts A and B |
| Declaration | Annex II | Annex V, Parts A and B |
| Instructions | Paper | Digital permitted, with paper on request free of charge; paper safety information required for non-professional users |
| Substantial modification | Not defined in the Directive; addressed through guidance | Defined in the Regulation, with consequences for whoever makes one |
What survives
- Your risk assessment method. The iterative approach and the three-step hierarchy are unchanged. The record needs reviewing against the new requirements, not replacing.
- Most of your test evidence. Mechanical, electrical and noise testing done against harmonised standards remains valid evidence; what changes is which standard reference you cite.
- Your drawings, calculations and instructions. Content-wise, largely intact.
- Your overall file structure, if it was organised around requirements rather than around the Directive's annex numbering.
What has to change
- Every citation. Declarations, file indexes and instructions that reference 2006/42/EC and its annex numbers must be rewritten to reference 2023/1230 and its annex numbers. This is tedious, it is unavoidable, and it is the work most often left to the last month.
- Your conformity assessment route, if your product moved between the old Annex IV and the new Annex I Parts A and B. Check this first — it is the only change that can add months. The lists →
- Digital and cybersecurity evidence. If your machinery has a control system that could be interfered with, the file now needs to show what you did about it. For most manufacturers this is genuinely new work.
- Machine learning in safety functions. If present, expect Part A and a notified body.
- The authorised representative arrangement, if you are outside the EU. Check the mandate is current and that the named person can actually produce the file.
- Instructions supply method, if you intend to move to digital. Add the access instructions and the free paper-on-request process.
On harmonised standards. A standard that gave presumption of
conformity under the Directive does not automatically do so under the Regulation. Standards are
being revised and cited progressively. Track the ones your product depends on, and do not assume a
citation will exist on 20 January 2027 — design against the essential requirements themselves so
that a missing citation is an inconvenience rather than a blocker.
A twelve-month plan from today
- Sep–Nov 2026: classify every product against Annex I Parts A and B. Identify any that changed route. Contact a notified body immediately for those.
- Dec 2026–Feb 2027: gap assessment of each technical file against Annex III, focusing on the digital and cybersecurity requirements.
- Mar–Jun 2027: close engineering gaps. This is the last window where a design change is cheap.
- Jul–Oct 2027: rewrite files, declarations and instructions against the new citations. Update the requirement-to-evidence index.
- Nov–Dec 2027: sign-off, declarations reissued, marking checked, retention arrangements confirmed.
If you are reading this after mid-2027 with nothing done, start with step one anyway — knowing which of your products changed route is the information that determines whether you have a problem or a paperwork exercise.
Get told when the requirements change
None of the 35 CRA harmonised standards is published yet. When they land — and when deadlines move — we email you. No more than twice a month.