Frequently asked questions on technical documentation

General description, overall drawing with control circuit diagrams, detail drawings with calculations and test results, risk assessment, list of applied standards and legislation, test and measurement records, a copy of the instructions for use and the declaration of conformity. For series production, the internal measures for ensuring conformity are added. Read in full

Everything that demonstrates conformity, from the design through the risk assessment to the test records, plus a file copy of the documents supplied with the machine. The technical documentation is therefore broader than what the customer receives. Its addressee is the market surveillance authority, not the operating company. Read in full

The complete technical file: risk assessment, design drawings and calculations, full circuit diagrams, test and measurement records, evidence for the safety functions including the performance level calculation, the list of standards with their editions, and the declarations and data sheets of bought-in components. For at least ten years. Read in full

Mandatory are the instructions for use and the EU declaration of conformity; for partly completed machinery the assembly instructions and the declaration of incorporation. Added to that are the markings on the machine itself, CE marking and rating plate, plus circuit diagrams to the extent required for operation and maintenance, and the maintenance and spare parts information. Read in full

Risk assessment, design drawings, strength and safety calculations, test and validation records, the complete list of standards and the declarations of conformity of bought-in components. They belong in the technical file and are only submitted to the market surveillance authority upon reasoned request. Handing them over can be agreed contractually; there is no obligation. Read in full

At least ten years from placing on the market, for series products from the last unit delivered. During that time the documents have to remain complete and legible and be unambiguously assignable to the machine in question. In practice this fails less often because a document is missing than because it cannot be matched to the revision status. Read in full

There is no fixed language requirement for the internal file. The market surveillance authority may however request a translation into a language it understands. It is sensible to keep at least the risk assessment and the list of standards in the language of the manufacturer's location. Read in full

Everything addressed to operators, maintenance staff or the operating company in the official language of the country of destination: instructions for use, warnings, markings, HMI texts and the declaration of conformity. Purely project-related documents between specialists, such as interface descriptions or acceptance records, may stay in English if that is agreed. Instructions solely for the manufacturer's own specialists may be written in their language. Read in full

No. It is part of the technical documentation and stays with the manufacturer. What the operating company actually needs are the residual risks, and those are in the instructions for use. If the customer asks for more, a residual risk list is usually the right answer. Read in full

No, the Machinery Regulation does not provide for that. Handing it over completely is purely a contractual service. Anyone agreeing to it should settle scope, confidentiality and rights of use in writing and hand the documents over with a confidentiality and ownership note. Read in full

The complete technical documentation including risk assessment, evidence and instructions for use, upon reasoned request by the market surveillance authority and within a reasonable period. They do not have to sit physically in one place but must be retrievable, complete and assignable. If the manufacturer is based outside the EU, an authorised representative established in the Union takes this on. Read in full

Yes. What matters is that the documents are complete, can be assigned unambiguously to a machine and remain legible throughout the retention period. Pay attention to file formats that can still be opened in ten years, and to a backup that survives the loss of one system. Read in full

The manufacturer within the meaning of the Machinery Regulation, that is whoever places the machine on the market under their own name. That can also be an operating company that links up an installation itself, or a main contractor. The declaration of conformity additionally names the person authorised to compile the technical documentation.

Essentially the same components as for machinery, related to the scope supplied: description, drawings, risk assessment for the hazards covered, evidence, and a statement of which essential health and safety requirements are met and which are not. Plus the assembly instructions and declaration of incorporation as file copies. Read in full

Assembly instructions and a declaration of incorporation. The assembly instructions describe assembly, connection and the conditions for safe incorporation into the final machinery. There is no CE marking under the Machinery Regulation and no declaration of conformity here. Read in full

The basic structure stays. New above all is evidence on cybersecurity and, for machinery with self-evolving behaviour, on keeping that behaviour under control. Added to that are requirements for providing instructions digitally and a changed procedure for high-risk machinery.

First the risk assessment, then everything that follows from it: instructions for use, circuit diagrams, test records, list of standards and, in the case of a substantial modification, the declaration of conformity and CE marking. Changes to software and parameters of safety-related functions have to be documented as well. The revision status should stay tied to the serial number.

Everything required to assess conformity: evidence for the safety functions including the performance level or SIL calculation and validation, electrical tests to EN 60204-1, strength and stability calculations, noise and emission measurements with the method used, and where applicable certificates from a notified body. Read in full

Yes, as far as they are required to assess conformity: overall drawing with control circuit diagrams, plus detail drawings, calculations and test results that demonstrate safety. Of these, only the circuit diagrams to the extent required for operation and maintenance are supplied to the customer. The complete design data set stays internal. Read in full

The market surveillance authority can request the documents, question conformity if gaps persist and order measures up to a sales ban or recall; fines follow national law. Independently of that, an incomplete file works against the manufacturer in a liability case, because the protective decisions taken can no longer be demonstrated. In practice what is missing most often is not the document itself but its assignment to the machine version delivered. Read in full