Machinery · Regulation (EU) 2023/1230 · applies from 20 January 2027 · looking for packaging?
Regulation (EU) 2023/1230 · replaces Directive 2006/42/EC

Are your machines ready for 2027?

Your customers will ask for the new declaration: with the old one, the machine does not ship.

From 20 January 2027 the Machinery Directive is replaced by a directly applicable regulation. Technical file, declaration of conformity and instructions must be rebuilt to the new annexes. We check what is missing and put it right, at a fixed price.

  • Done by Tom Riby, Gaiole in Chianti
  • Check €1,900, fixed price
  • Report in 10 working days
Request the 2027 CheckWhat changes in 2027
Applies from
20.01.2027

No transition period for machinery placed on the market from that date.

What changes

This is not a formatting update.

Moving from a directive to a regulation removes national transposition: the same text applies across the EU. The content changes too.

The technical file is rebuilt

The required contents are listed in Annex IV of the regulation and do not match those of the directive. A file that complies with 2006/42/EC is not automatically compliant.

Software and functional safety

The regulation explicitly addresses software performing safety functions and systems that evolve over time. If a PLC governs a safety function, it must be documented as such.

Cybersecurity

The essential requirements cover protection against accidental or intentional corruption of software and data affecting safety. This is new ground compared with 1993 and 2006.

High-risk machinery

The list of categories requiring a notified body has changed. If you fall in scope, self-certification is no longer enough — and notified bodies have queues.

Digital instructions

Instructions for use may be supplied digitally, but on the user's request they must also be provided on paper, at no extra cost. This needs to be designed into the process.

Substantial modification

The regulation defines when a change to a machine already on the market creates a new machine with new obligations. It affects retrofitters and line integrators.

What you receive

A report, item by item.

The 2027 Check compares your current file with Annex IV and the new requirements, and says for each item: compliant, to update, missing. With a fixed quote to fix it.

What is at stake

The first cost is not the fine. It is the delivery that stops.

Penalties are set by Member States. In Italy today Article 15 of Legislative Decree 17/2010 applies: €4,000–24,000 for placing a non-conforming machine on the market, and €2,000–12,000 for failing to produce the technical file on request from the surveillance authority. Italy's decree adapting to the new regulation is not yet published. But the real cost arrives earlier, from three directions.

The customer does not accept delivery

Industrial buyers are already writing 2023/1230 conformity into contracts for 2027 deliveries. Without a correct declaration the machine stays in your workshop and the balance goes unpaid.

Market surveillance

Authorities can prohibit making available, and require withdrawal or recall of non-compliant machinery. A recall on an installed line costs far more than the file.

Liability after an accident

The technical file is the first document requested after an incident. An incomplete or outdated file is the manufacturer's problem, not the user's.

We do not provide legal advice and we do not certify: we prepare documentation and tell you precisely where you are exposed.

The offer

Fixed price per machine family.

A family is a group of machines sharing the same safety architecture and base technical file: dimensional or trim variants belong to the same family.

2027 Check

€1,900
per machine family · 10 working days
  • Review of the existing technical file against Annex IV
  • Analysis of the new essential requirements: safety software, cybersecurity, digital instructions
  • Whether you fall within the categories requiring a notified body
  • A specific report: what is missing, what must be rewritten, what only needs updating
  • Fixed quote for the rebuild, no obligation
  • If you proceed within 60 days, the €1,900 is credited against the quote
Request the Check

File Rebuild

from €5,500
per machine family · fixed quote after the Check
  • Technical file rewritten to Annex IV
  • EU declaration of conformity updated to the regulation
  • Risk assessment (EN ISO 12100) coordinated with a partner engineer, who signs it
  • Instructions for use aligned, including the digital format
  • Notified body coordination where required
  • First 3 months of Machinery Custody included

Machinery Custody

€190
per month, per machine family
  • File kept with every version
  • Updates when harmonised standards and the state of the art change
  • New variants of the same family at a reduced price
  • Authority requests answered within 10 days

€290 per month for machines with software-driven safety functions or notified-body certification.

Prices exclude VAT. Laboratory testing and notified-body fees, where required, are separate and always quoted first. The EN ISO 12100 risk assessment is carried out and signed by a partner engineer under their own professional liability: we handle the documentation and hold the project together.

How it works

Three steps, all remote.

01 · You send the file

You send us the current technical file and declaration for a representative machine. A secure link, no software to install.

02 · Check in 10 working days

You receive a report listing, point by point against Annex IV, what conforms and what does not, with a fixed quote to fix it.

03 · Rebuild

If you proceed, we rewrite the file, declaration and instructions. You review and sign: the manufacturer remains responsible for conformity, as the regulation requires.

Request the 2027 Check

Four fields. We reply within one working day.

We work asynchronously: no surprise phone calls, no hour-long discovery meetings. Tell us what you build, we reply by email with the next steps and a fixed quote. Or write directly to hello@fascicolo.eu.

Prefer to write? hello@fascicolo.eu

No newsletter. We use these details only to answer your request.

Who we are

One person, not a call centre.

Fascicolo is a compliance documentation service for European SMEs, run by Tom Riby from Gaiole in Chianti, Italy. We work asynchronously, at fixed prices, with a limited number of clients at a time: we would rather say no than deliver late. Safety work — the EN ISO 12100 risk assessment — is handled by a partner engineer who signs it and answers for it. Documentation is produced in Italian and English.

Request the 2027 Check

Photo
Tom RibyBritish, 12 years in Tuscany, in Italian industryGaiole in Chianti (SI), Italyhello@fascicolo.euWrite to me
Questions
Do machines already sold have to be redone?

No. The regulation covers machinery placed on the market from 20 January 2027. Machines already placed remain under the rules in force at that time, unless a substantial modification makes them new machines.

My technical file is good under the Machinery Directive. Is that enough?

It is a strong starting point but not sufficient: the required structure changes and there are new requirements, particularly on safety software and cybersecurity. The Check measures the distance between what you have and what is needed.

Is the €1,900 lost if I then order the rebuild?

No. If you proceed with the rebuild within 60 days of the report, the €1,900 is credited against the quote. The report remains yours either way, usable with any provider.

Who signs the risk assessment?

A partner engineer, under their own professional liability and insurance. We do not sign risk assessments: we handle the technical file, declaration, instructions and retention. That line is written into our terms.

Do you sign the declaration?

No, and nobody can do that for you. The EU declaration of conformity is signed by the manufacturer or their authorised representative, who remains responsible. We prepare the documentation that supports it.

We are outside the EU. Does this apply to us?

Yes, if your machines are placed on the EU market. Non-EU manufacturers have the same obligations and generally need an authorised representative established in the Union. We work in English throughout for this reason.

Data collection and document tooling. Not legal advice. The declaration is signed by the manufacturer's legal representative, who remains responsible for it.

EU Machinery Regulation 2023/1230 | Fascicolo