Machine safety is not just a legal obligation, it's the pillar of trust between manufacturers and users. With the advent of the new Machinery Regulation (EU) 2023/1230, Europe is taking a decisive step towards the digital era and cybersecurity - and with Reesly you can face the change without starting from scratch: the platform is already ready for the new Regulation, Essential Requirements checklist included.
Why Machinery Regulation Is Changing
Regulation (EU) 2023/1230 entered into force in July 2023 and will become the sole legal reference from 20 January 2027, repealing Directive 2006/42/EC. It's not a simple formal update: the structure of the annexes changes, the way safety requirements are assessed changes, and for the first time the legislation explicitly treats software, artificial intelligence and cybersecurity as an integral part of machine safety. Those who prepare today, with a tool designed for both regulatory frameworks, will reach 2027 without having to redo the work from scratch.
Directive vs Regulation: The Complete Comparison
While Directive 2006/42/EC has served the industry for over 15 years, the new Regulation introduces substantial changes to address modern technological challenges. Here are the main differences:
| Area | Directive 2006/42/EC | Regulation (EU) 2023/1230 |
|---|---|---|
| Application | Requires national transposition | Direct and uniform application across the EU |
| Structure and annexes | Annex I: generic essential requirements | Annex III: 163 indexed Essential Safety Requirements |
| Requirements analysis | Free-form assessment, often on scattered sheets | Point-by-point checklist, requirement by requirement - automatable with Reesly |
| Instructions | Predominantly paper-based | Digital format allowed (with right to a paper copy) |
| Declaration of conformity | EC declaration of conformity (Annex II.A) | EU declaration of conformity (Annex V) |
| Safety components | Annex V: physical components (relays, guards, sensors) | Annex II: also includes software and self-evolving (ML) safety components |
| Substantial modifications | Interpretive grey area | Clear definition and specific obligations |
| Cybersecurity | Not explicitly addressed | Essential safety requirement |
| Artificial Intelligence | Not addressed | Specific requirements for AI-based safety functions |
| Market surveillance | Less harmonised controls between Member States | Strengthened, uniform powers and control procedures |
Reesly ProTip
Did you know the new Regulation allows a digital manual? With Reesly you're already ready: our manuals are digital-native, QR-code ready and always accessible.
Discover the manual generator →Essential Safety Requirements: From a Generic Annex to 163 Indexed Points
Under the Directive, Annex I listed essential requirements in narrative form: it was up to the manufacturer (or their consultant) to interpret them and figure out which ones applied to the specific machine. The Regulation changes approach: Annex III structures everything into 163 specific, indexed Essential Health and Safety Requirements (ESR), designed to be verified one by one.
It's a positive change for documentation quality, but also more time-consuming: 163 points to examine, for every machine, every time. We've indexed and made searchable the entire list in our guide to Essential Safety Requirements.
New on Reesly
The analysis of the 163 ESRs, already filled in for you
Reesly automatically generates the checklist of Essential Safety Requirements applicable to your machine under the new Regulation, and for each requirement it already inserts the starting regulatory text: you don't start from a blank page, but from a ready-made base to verify, complete and sign. What used to take days of reading and transcribing the standard becomes an immediate starting point for your technical assessment.
- Checklist of the 163 ESRs generated automatically
- Regulatory text pre-filled for each requirement
- Linked to the Technical File and the Declaration of Conformity
Safety Components and Software: Annex V Expands
Annex V lists safety components. The most significant novelty of the Regulation is the inclusion of software performing safety functions, which must now be treated with the same documentary rigour as a relay or a physical guard: certificates, supplier traceability, verified technical data. Our safety components database is already organised to handle both types, with standardised datasheets ready to link to the Technical File.
What Manufacturers Should Do Today
There's no need to wait for 2027 to prepare. Here are the concrete steps, and how Reesly covers each one:
- Map the applicable ESRs for your machines across the 163 points of Annex III - with Reesly the checklist is generated automatically, text included.
- Take stock of your safety components, software included - with Reesly you have a single, always up-to-date database.
- Check the manual's format and prepare for the digital option - with Reesly the manual is digital-native, QR-code ready.
- Keep the Technical File and the Declaration of Conformity aligned as the regulation evolves - with Reesly they're linked to the same data, always consistent.
In short: the regulatory transition is not a single event to endure in January 2027, but a process to manage with the right tool starting now. This is exactly why Reesly was built as a CE compliance management software and not a simple document generator: compliance changes over time, and the platform has to change with it.
Frequently Asked Questions (FAQ)
When does the new Regulation come into force?
It entered into force in July 2023, but will become the sole legal reference from 20 January 2027. Until then, there's a transition period.
Do I have to reprint all the manuals?
No. If you apply the new Regulation, you can provide the manual in digital format (web download, USB drive), but you must clearly indicate how to access or download it.
What happens to older machines?
The Regulation applies to machines placed on the market after the date of application. Existing machines continue to be governed by the rules in force at the time they were placed on the market.
What is Essential Safety Requirements (ESR) analysis and how does Reesly automate it?
It's the requirement-by-requirement assessment of which of the 163 ESRs in Annex III apply to your machine. Reesly generates the checklist with the relevant requirements and already inserts the starting regulatory text for each one: a ready-made base to complete, not a blank page.
Can I already prepare for Regulation (EU) 2023/1230 with Reesly?
Yes. Reesly handles both Directive 2006/42/EC and the new Regulation: Technical File, Declaration of Conformity, digital manual, safety components and the automatic ESR checklist are already available on the platform. Request a demo.
To learn more: Essential Safety Requirements, Safety Components Database, CE Compliance Software, CE Marking Software, Technical File Software.