Technical file gaps: evidence and closing costs

Technical file gaps should be reviewed against a narrow procurement question: is the evidence complete enough to support the manufacturer’s conformity decision for the exact robot being bought? The review is not a CE certificate, and a coloured spreadsheet cannot turn missing engineering evidence into compliance. Its useful output is a controlled list of what is present, what is missing, what is inadequate, who must close each gap, and which commercial commitment depends on closure.

The timing matters. The European Commission says Regulation (EU) 2023/1230 applies on a mandatory basis from 20 January 2027. Machinery placed on the EU market before that date must comply with Directive 2006/42/EC. A hotel reviewing a file in 2026 therefore needs the expected placing-on-the-market date and the applicable legal regime. It should not mark a 2006/42 file against the new Annex IV without explaining that the exercise is a readiness review rather than the mandatory assessment route for that placement.

Start with the product and the legal route

Do not open with a document count. Start with the machine identity: model, variant, serial or batch range, software and safety-control versions, intended use, reasonably foreseeable misuse, accessories, charging equipment, lift or door interfaces, and the economic operators named on the product and declarations. A test report for a similar model may be useful background, but it is not automatically evidence for the purchased configuration.

The 27 July 2026 consolidated text of Regulation (EU) 2023/1230 requires the manufacturer to draw up the technical documentation in Annex IV Part A. The manufacturer must also carry out the applicable Article 25 conformity assessment before placing the product on the market or putting it into service. Part B covers partly completed machinery. The distinction changes the documents and the party that must complete the final machinery assessment.

Record the conformity route beside the product identity. Check whether the product falls within Annex I, whether a harmonised standard route is claimed, and whether a notified body is required or has been used. The common EU conformity-assessment framework explains why technical documentation and supporting evidence sit inside the chosen module. The file review cannot be separated from that route.

Build an Annex IV evidence map

Annex IV Part A is the review index for machinery and related products. Map each requirement to an exact file name, revision, date, author or issuing laboratory, and applicable product version. Start with the general description, drawings, control-circuit descriptions, risk assessment, applicable health and safety requirements, protective measures and residual risks. Then map the standards or other technical specifications, calculations, examinations, test results, instructions, incorporated-product documents and the EU declaration of conformity.

The official European Commission CE-marking overview places technical documentation inside the manufacturer’s conformity work. In practice, the file must show design, manufacture and operation, identify applicable rules and standards, record risk analysis, and explain how risks were addressed. A folder full of certificates without the chain from hazard to requirement, design measure and verification result is not a usable technical case.

For machinery placed before 20 January 2027, use Directive 2006/42/EC and its Annex VII as the mandatory baseline. Keep a separate readiness column for the 2023/1230 changes. This avoids two errors: claiming that the new Regulation already governs every 2026 placement, or waiting until 2027 to identify evidence that will be expensive to reconstruct.

Use three marks, then add an ownership field

Mark	Meaning	Acceptable record	Next action
Present	The required evidence exists, matches the exact product and is internally consistent.	File name, revision, date, product version and reviewer note.	Preserve the controlled copy and check whether later changes affect it.
Missing	No evidence was supplied for an applicable requirement.	The request made, supplier response and due date.	Assign the manufacturer or other responsible party to create or obtain it.
Inadequate	A document exists but cannot support the claimed conclusion.	The defect, affected requirement and consequence.	Revise, repeat, extend or replace the evidence.

Do not use “present” to mean that a filename exists. A risk assessment that omits collision during map loss is inadequate if that hazard is reasonably foreseeable. A test report with no model linkage is inadequate. An unsigned declaration is inadequate. A manual for another software branch is inadequate. The defect note should be factual and specific enough for an engineer or laboratory to act on it.

Add two fields that the traffic-light view usually misses: owner and acceptance condition. The owner may be the manufacturer, importer, integrator, test laboratory, translation provider or hotel. The acceptance condition states what closes the gap, such as a revised risk assessment approved under document control or a test report that identifies the exact hardware and software configuration. Without those fields, the register records concern but does not manage work.

Separate the duties in the supply chain

The manufacturer owns the technical documentation and the conformity assessment. The Commission’s CE guidance for manufacturers lists the core sequence: identify applicable rules and standards, verify requirements, carry out the assessment, set up technical documentation, issue the declaration and affix the marking. A consultant may review or help prepare evidence, but the consultant does not replace the manufacturer or assume the declaration merely by annotating the file.

Under Article 13 of the current Regulation, an importer must check that the manufacturer completed the appropriate assessment and drew up Annex IV Part A documentation. The importer keeps a copy of the EU declaration of conformity for at least ten years and must ensure that the technical documentation can be made available to authorities on request. A distributor performs document and marking checks under Article 15. The hotel’s purchase team should identify which role its supplier actually occupies instead of accepting the word “dealer” as a legal classification.

The hotel is normally the user and employer, not the manufacturer. That can change if it manufactures machinery for its own use or makes a substantial modification under Article 18. Integration decisions involving payload, speed, sensors, maps, APIs, automatic doors or lifts must be screened before they are treated as harmless configuration. Ergasa’s earlier analysis on who is the service robot manufacturer explains the role classification, while the notified-body decision guide covers the Annex I route.

Test quality, not paper volume

A good review follows claims across documents. The intended use in the manual should match the risk assessment. The model on the declaration should match the label and test reports. Protective measures in the risk assessment should appear in drawings, control logic, verification records and user instructions. Residual risks should reach the operator. Software that affects a safety function should have a controlled identity and change history.

Standards need the same treatment. Under Regulation (EU) No 1025/2012, a harmonised standard is adopted following a Commission request, and its reference is published for the relevant legislation. The current implementing decision listing machinery standards for Directive 2006/42/EC is the place to verify published references for the present regime. A supplier’s bare statement that it used “ISO standards” does not establish which requirements receive a presumption of conformity.

The 2022 Blue Guide is useful for checking the horizontal logic of technical documentation, traceability and economic-operator roles. It is guidance, not a substitute for the sector legislation. Record which source controls each conclusion so that a future reviewer can distinguish law, Commission guidance, a harmonised standard and the team’s own interpretation.

Turn technical file gaps into scoped work and cost drivers

Closing cost is not the number of red cells multiplied by a standard fee. One missing declaration may take little time after the evidence is complete. One inadequate risk assessment may require design changes, software work and repeat testing. Price each gap as a work package only after the acceptance condition and responsible party are clear.

Rank technical file gaps by the decision they block, not by how untidy the document looks. A gap tied to an unresolved safety function or conformity route carries a different procurement consequence from a formatting defect.

Work package	Typical trigger	Cost driver to quote
Document reconstruction	Drawings, bills of materials or design calculations are absent or uncontrolled.	Engineering hours, product variants and access to original design data.
Risk-assessment repair	Hazards, applicable requirements or risk-reduction measures are incomplete.	System boundaries, operating modes, interfaces and specialist disciplines.
Verification or testing	A safety claim has no traceable result or the tested configuration differs.	Laboratory scope, samples, fixtures, travel, repeat tests and report revision.
Software evidence	Safety-related versions, logic, validation or update control are unclear.	Code access, architecture review, configuration baseline and regression tests.
Conformity-body work	The chosen Article 25 route requires independent assessment.	Scope, review rounds, testing, audit time and corrective actions.
Instructions and translation	Required information is missing, inconsistent or unavailable for the Greek user.	Source quality, technical writing, languages, review and controlled reissue.

Use a transparent estimate: total gap-close cost equals internal hours at the hotel’s or importer’s loaded rate, plus supplier engineering, external testing, conformity-body fees where applicable, translation, travel, samples, retesting, and operational delay. Keep every input as a quote or named assumption. Do not manufacture a return-on-investment percentage from an unfinished file.

The market-surveillance framework in Regulation (EU) 2019/1020 gives authorities powers to request documents, technical specifications and compliance information, including access to embedded software where necessary. That enforcement exposure is one reason to cost document access and retrieval time rather than assume the supplier will answer later.

Use procurement gates instead of a certificate claim

The mark-up should control commercial decisions. A hotel can tie deposit release, shipment, final payment, site acceptance and go-live to different evidence states. A missing manual translation may block go-live but not factory testing. A missing conformity route or an unresolved safety-control test should block acceptance much earlier. The contract must say which party pays for closure and what happens if the evidence never arrives.

Decision checklist

• Identify the exact model, configuration, software baseline, accessories and intended use.
• Confirm the expected placing-on-the-market date and the applicable machinery regime.
• Classify the product as machinery, a related product or partly completed machinery.
• Record the manufacturer, importer, distributor, integrator and hotel roles.
• Map every applicable Annex IV or Annex VII item to controlled evidence.
• Mark each item present, missing or inadequate and explain the evidence basis.
• Assign an owner, acceptance condition, due date and affected payment or deployment gate.
• Verify the conformity route, standards references and any notified-body involvement.
• Obtain quotes for defined work packages and keep assumptions separate from prices.
• Re-review the file after design, software, interface or intended-use changes.

Keep the review conclusion narrow: “no unresolved gaps were found against the stated scope and documents reviewed” is defensible when true. “CE approved” is not. CE marking is the manufacturer’s declaration after the applicable assessment, not a general approval sold by a reviewer. The original legal act and its consolidated version should remain the reference points for the final legal check.

A procurement review has limits. It may not establish whether hidden source code implements the claimed safety logic, whether a sample represents series production, or whether an interface change is substantial. State unavailable evidence, sampling limits, translations relied upon, software access limits and unresolved legal interpretation. Where the route, Annex I classification or test scope is uncertain, obtain advice from a qualified machinery-safety professional, competent legal adviser or appropriately notified body.

This analysis is not legal advice and does not certify a robot. Its purpose is to stop a hotel from confusing a neat document pack with a demonstrated conformity case. The next decision is practical: freeze payment or deployment at the relevant gate until the named owner supplies evidence that meets the recorded acceptance condition.

Frequently asked questions

Does a complete mark-up prove that the robot is CE compliant?

No. It records the scope and result of a document review. The manufacturer remains responsible for the applicable conformity assessment, technical documentation, EU declaration and CE marking. A reviewer should not describe the spreadsheet as a certificate.

Can we accept a test report for a similar robot model?

Only after the manufacturer shows why the tested configuration represents the purchased product and which claims the report supports. Differences in payload, sensors, brakes, control software, battery or operating environment may make the report inadequate.

Must the hotel receive the manufacturer’s entire technical file?

The Regulation requires the manufacturer to keep the documentation available to authorities, while the importer must ensure it can be made available. A hotel may not have an automatic right to every confidential design detail. It should contract for enough evidence, access and response obligations to complete due diligence and support safe deployment.

How should we price an inadequate risk assessment?

Do not assign a flat price to the label. Define the missing hazards, interfaces, requirements, protective measures and verification work. Then obtain quotes for the engineering, testing, documentation and review needed to meet the acceptance condition.

What happens when software changes after the review?

Screen the change against the risk assessment, safety functions, intended use and configuration baseline. Update affected evidence and repeat verification where necessary. A file that matched version A does not automatically support version B.