Custom Machinery Regulation conformity file development
Appfront builds file management systems for machine builders preparing for the new Machinery Regulation, which applies from 20 January 2027 and replaces the Machinery Directive. Per machine and variant: the technical file, the risk assessment, the essential requirements with the evidence attached, the applied standards, the conformity assessment and the EU declaration of conformity. With versions, an overview of what is still missing, and a file that is ready when a regulator asks.
What is a conformity file for the Machinery Regulation?
From 20 January 2027 the European Machinery Regulation applies. It replaces the Machinery Directive and sets requirements for machines placed on the EU market. Much stays the same: a risk assessment, essential health and safety requirements, a technical file, a conformity assessment, an EU declaration of conformity and the CE marking. But there are new requirements too, including for software, cybersecurity and machines with self-learning behaviour, and the structure of the annexes changes.
At many machine builders the technical file is scattered: the risk assessment in a spreadsheet, calculations and drawings in PDM, test reports on a shared drive, and the instructions with the technical writer. Which requirement is covered by which evidence is known only to certain people. A variant of a machine gets a different component, and the risk assessment is not updated. For the transition to the regulation, every file needs to be reviewed again.
We build custom solutions because machine builders differ: which machines and variants, how your risk assessment is structured, which standards you apply, which PDM and ERP you use, and whether a notified body is involved. What the regulation requires for your machines is determined with your machinery safety adviser; the system records what is needed for that and shows where it is missing.
File per machine and variant
Technical file per machine and variant, with the components the regulation requires.
Requirements with evidence
Every essential requirement linked to the risk assessment, the evidence and the applied standards.
Ready for the transition
An overview per file of what still needs to be completed for the Machinery Regulation.
How we build your conformity file for the Machinery Regulation
We start with one machine: how the file is structured now, where the components are, and what changes with the regulation.
Your machines, variants, risk assessments, standards, PDM and ERP.
The structure of the technical file, and requirements linked to evidence.
Risk assessment per machine, and what differs per variant.
Conformity assessment, declaration, an overview of open actions, and management.
What a conformity file for the Machinery Regulation actually does
The components below appear in almost every machine builder's work. Which ones you need depends on your machines.
Machines and variants
Machines with variants and their differences.
Risk assessment
Hazards, risks and measures per machine.
Requirements and evidence
Essential requirements linked to evidence and standards.
Technical file
The components the regulation requires.
Declaration
Conformity assessment and EU declaration of conformity.
Versions
Versions of documents, linked to the machine.
Who we build a Machinery Regulation conformity file for
The system is intended for anyone who prepares or manages technical files for machines.
Machine builders
Many machines with variants. The file per variant is the core.
Production line builders
Assembled installations. The risk assessment matters most.
Importers
Machines from outside the EU. The manufacturer's evidence is what is needed.
Advisers
Files for multiple clients. The overview per client is the core.
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This page is about the conformity file for the Machinery Regulation. For machine building in general, see our page on machine building software; for configuring machines, our page on a machine tool configurator; and for medical devices, our page on an MDR technical file. You can read about our approach at building software.
Why choose Appfront for your Machinery Regulation conformity file?
A requirement without evidence is only discovered after an accident or when an inspector asks, not before. We build on that: one file per machine and variant, requirements backed by evidence, and an overview of what is missing.
Gaps spotted early
What is missing is visible before anyone asks.
Variants are accurate
A change to a variant affects the correct risk assessment.
Ready for 2027
Each file shows what the regulation requires.
Security and privacy for a Machinery Regulation conformity file
The system holds confidential information about your machines, such as design, calculations and risks. Access is set by role, and every change is logged.
The system runs in a European data centre or in your own environment, with encrypted storage, daily backups and sign-in with a second factor.
Frequently asked questions about a Machinery Regulation conformity file
Questions machine builders ask before getting started.
It organises the technical file by machine and variant, links the essential requirements to the risk assessment, evidence and standards, manages the conformity assessment and declaration, keeps track of versions, and shows what is still missing.
From 20 January 2027. It then replaces the Machinery Directive. Machines placed on the market from that date must comply with the regulation.
Much of the foundation remains, such as the risk assessment, technical file and declaration of conformity. New elements include requirements for software, cybersecurity and machines with self-evolving behaviour, a different arrangement of the annexes, and the option of a digital instruction manual. Discuss what changes for your machines with your adviser.
For each variant it is recorded what differs from the base machine. A change to a variant shows which parts of the risk assessment and file need revising.
Yes. Existing documents and risk assessments are placed in the structure and linked to the requirements. This shows, for each file, what still needs to be added for the regulation.
Yes, provided it has an interface. Drawings, calculations and bills of materials can come from PDM, so the file refers to the current version.
Ask that first. There are packages for risk assessment and CE marking, and they work well if they fit your way of working. Custom software makes sense if you have many variants, want the file integrated with PDM and ERP, or work as an adviser for several clients.
Are your technical files ready for 2027?
Tell us which machines and variants you build, how your files are currently structured and which software you use. We'll show you what the file, the requirements and the overview look like.