Machinery Regulation guide

Technical documentation: scope, retention and access protection

From risk assessment to declaration of conformity: what must remain deliverable for 10 years — and what may stay protected.

What belongs in the technical documentation

The technical documentation is the evidence that the machinery meets the requirements of the Regulation. It includes in particular the risk assessment, design and manufacturing documents (drawings, circuit diagrams, calculations), the standards applied and test records, the operating instructions and the EU declaration of conformity.

New compared with the Machinery Directive: aspects such as cybersecurity and — for self-learning systems — the intended behaviour must also be considered and documented in the risk assessment, where relevant to the machinery.

10 years of retention, deliverable at any time

The manufacturer must retain the technical documentation for 10 years from the placing on the market and be able to present it to the market surveillance authorities upon reasoned request. That sounds trivial, but in practice it often fails due to organically grown filing: folders on network drives, versions in email attachments, drawings in the CAD system.

A digital machine file with versioning solves this structurally: each machine has a complete, versioned set of documents that even years later proves which version applied at the time of delivery. Archiving thus turns from a search problem into a retrieval problem — and that is solvable.

Public vs. protected

Not everything that is documented is meant for everyone. The operating instructions must be freely accessible to operators and technicians — circuit diagrams, design drawings and costing documents, by contrast, contain know-how that manufacturers want to protect and are entitled to protect.

In practice, this calls for document-level permissions within a machine file: anyone can open the operating instructions via QR code, while protected folders require a PIN or an authorisation. Exactly this pattern — public operating instructions, protected circuit diagrams and drawings — is one of the most frequent requirements from the machinery sector, and docks implements it with permissions per folder and per document.

FAQ

Frequently asked questions

How long must technical documentation be retained?

10 years from the placing of the machinery on the market. During this period it must be capable of being presented to the market surveillance authorities upon reasoned request.

Must circuit diagrams be publicly accessible?

No. It is the operating instructions that must be freely accessible. Detailed documents such as circuit diagrams and design drawings may remain access-protected — for example via a PIN or an authorisation within the machine file.

May the technical documentation be kept purely digitally?

Yes, digital record-keeping is permissible and in practice the more robust option: with versioning and audit-proof filing, it can be demonstrated at any time which version applied at the moment of delivery.

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More chapters of this guide

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