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CE documentation for robot cells, ready for 2027.

CellFile guides integrators through a structured risk assessment, the applicable essential health and safety requirements, the technical file and a draft EU declaration of conformity — built around Regulation (EU) 2023/1230, which applies from 20 January 2027.

Free to join No spam €79 / month at launch

Problem01 / 07

Why it hurts today

  1. P-01

    New rules, fixed date. From 20 January 2027 Regulation (EU) 2023/1230 replaces the Machinery Directive, and most in-house templates were written for the old one.

  2. P-02

    Every cell starts from a blank document. The technical file takes many engineering hours per project, in Word and Excel, and little of it carries over to the next cell. Dedicated safety software exists, but it is priced and designed for large machine builders.

  3. P-03

    When you integrate the cell, you are usually its manufacturer. You sign the declaration and affix the CE marking, so a gap in the documentation is your legal exposure — not the robot vendor's.

Solution02 / 07

What CellFile does

  • Structured risk assessment

    Limits of the machine, hazard identification, risk estimation and risk reduction, in the order the ISO 12100 method describes — every decision recorded and traceable.

    B-01
  • Applicable requirements only

    A checklist of the essential health and safety requirements in Annex III, narrowed to what applies to your cell, with evidence linked to each item.

    B-02
  • Reuse instead of rewrite

    Start each project from your previous cells and a library of components and hazards — robots, end effectors, guards, safety devices — instead of a blank file.

    B-03

Process03 / 07

How it works

  1. Step 1: Describe the cell

    Robot, end effectors, conveyors, guarding, safety functions, operating modes and intended use.

  2. Step 2: Assess the risks

    Work through hazards and risk reduction measures step by step, following the ISO 12100 method.

  3. Step 3: Check the requirements

    Confirm each applicable essential requirement and attach the evidence: drawings, calculations, validation and test reports.

  4. Step 4: Export the file

    Generate the technical file and a draft EU declaration of conformity as PDF or DOCX, for your review and signature.

Audience04 / 07

Who it's for

  • Robot and system integrators who assemble robots, tooling and third-party machines into cells
  • Machine builders moving their CE process from the Directive to the Regulation
  • Small engineering teams (2–50 people) documenting in Word and Excel today
  • Safety engineers and consultants who prepare CE files for their clients

Pricing05 / 07

Simple, early-customer pricing

CellFile is in development. Join the waitlist for free and we’ll email you when it’s ready.

Founding-customer pricing is reserved for people on the waitlist.

Founding integrator

Early access

€79 / month

Founding price for the first teams on the waitlist. Pre-orders open soon: the first month is charged upfront and fully refunded if CellFile doesn't launch.

  • Unlimited cell projects
  • Guided risk assessment following the ISO 12100 method
  • Annex III requirements checklist with linked evidence
  • Technical file and draft EU declaration of conformity export (PDF, DOCX)
  • Reusable library of components, hazards and protective measures
  • Direct line to the engineers building it

FAQ06 / 07

Questions, answered

Q01 Does CellFile make my cell compliant?

No software can do that. CellFile supports the engineer's work: it structures the risk assessment, the requirements checklist and the documents. The safety assessment, the technical decisions and the signature on the declaration of conformity remain yours. CellFile is not legal advice and does not replace a qualified consultant or, where required, a notified body.

Q02 What changes from the Machinery Directive to the Machinery Regulation?

Directive 2006/42/EC had to be transposed into each country's law. Regulation (EU) 2023/1230 applies directly and in the same way in every member state from 20 January 2027, when the Directive is repealed. The essential requirements are updated — for example on protection against corruption (Annex III, 1.1.9) and on control systems, including software — and instructions may be provided in digital format.

Q03 Who is the manufacturer of a robot cell?

In most cases the integrator who assembles a robot and other machinery into an assembly of machinery is treated as the manufacturer of that assembly, and is responsible for its conformity assessment, declaration and CE marking. Your contracts and the specific configuration matter, so check your own situation.

Q04 Do you follow ISO 12100?

Yes. The risk assessment workflow follows the method described in EN ISO 12100 (general principles for design — risk assessment and risk reduction). CellFile is not certified by ISO or any other body, and it does not include the text of the standards: you need your own copies of the standards you apply.

Q05 Where is project data stored, and who can see it?

Your projects are private to your team. We are building CellFile to host data in the EU, encrypt it in transit and at rest, and never use your projects to train models or share them with third parties. You will be able to export and delete everything at any time.

Q06 Which export formats will be supported?

PDF for the finished technical file, and DOCX so you can edit the documents or move them into your own templates. The EU declaration of conformity is exported as a draft for you to review, complete and sign.

Q07 When will it be available?

CellFile is in development. We are onboarding a small group of founding integrators first, in stages ahead of the 20 January 2027 deadline. Join the waitlist and we'll email you when there is something to try.

Q08 Can I pre-order?

Pre-orders open soon, first for people on the waitlist. A pre-order charges the first month (€79) upfront. If CellFile doesn't launch, you get a full refund, and you can ask for a full refund at any time before delivery, for any reason; we process refunds within 14 days.

Access07 / 07

Get early access

We're onboarding a small group of integrators first. Leave your work email and we'll contact you when a pilot slot opens.

Questions? hello@holtrane.com

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