Robot manufacturers preparing EU products for 20 January 2027 need a dated decision on product scope and responsibility, the applicable safety requirements, a suitable conformity assessment route and evidence that matches the product they will supply. Regulation (EU) 2023/1230 principally applies from that date. Products placed on the market in conformity with the Machinery Directive before the transition benefit from Article 52, so the change does not create a blanket requirement to recertify every existing robot. (Articles 51, 52 and 54)
The useful starting point is one real delivery. A robot arm, an unfinished assembly and a complete cell may share hardware while carrying different responsibilities. A model first sold before the transition may also have later units first supplied afterwards. A team needs to know which product and event its decision covers before it can decide which evidence to update.
Start with the product and the responsible manufacturer
The Regulation covers machinery, specified related products and partly completed machinery. Its definition of machinery includes assemblies controlled to function as an integral whole and an assembly missing only the application software upload foreseen by the manufacturer. Its safety-component definition can include independently marketed digital components and software. “Robot” is therefore a useful product description, but it is not an applicability decision. (Articles 2 and 3)
Check the specific application, what is supplied and what integration remains. Partly completed machinery cannot itself perform the specific application and is intended for incorporation into machinery. Missing a power connection, site installation or software upload does not automatically establish that category, because the machinery definition addresses those situations too.
The manufacturer can be the person having a product designed or manufactured and marketing it under their name or trademark. The definition also includes manufacturing a product and putting it into service for one's own use. A supplier arrangement or an internal installation therefore needs a clear responsibility record. An importer and distributor have distinct definitions, so the location of the engineering team alone does not settle the role. (Article 3(10)–(21))
Record any exclusion or more specific legislation with its conditions. Article 2 includes exclusions for machinery specially designed and constructed for military or police purposes, and for machinery or related products specially designed and constructed for research purposes for temporary use in laboratories. These are narrower descriptions than “a defence customer” or “a prototype”. Article 9 also addresses risks covered by more specific EU harmonisation legislation. (Articles 2 and 9)
Use a product-scope and market-date decision sheet
The following is a suggested working record. It helps the team retain the facts and reasoning behind a decision, rather than replacing the legislation's requirements.
| Decision field | What to record | Why it matters |
|---|---|---|
| Product identity | Model, unit or batch, supplied configuration and intended application | Identifies the actual product being assessed |
| Supply boundary | Arm, related product, partly completed assembly or integrated machinery, with the definition relied on | Separates product categories and integration responsibilities |
| Manufacturer | Legal entity and the activity establishing its role | Identifies responsibility for design, evidence and declaration |
| EU market event | Facts and supporting records for first EU supply, including supply free of charge where relevant | Establishes placing on the market |
| First use | Intended first use in the Union, where putting into service is relevant | Covers the distinct use event and own-use manufacture |
| Exclusions and other rules | Specific provision, conditions and risks covered | Makes scope reasoning inspectable |
| Applicable date and text | Relevant event date, law version and transition provision | Prevents a build date from standing in for the legal event |
| Decision and open issue | Responsible reviewer, decision reference and unresolved facts | Keeps uncertainty visible before delivery |
Article 3 distinguishes making available, placing on the market and putting into service. Making available is supply for distribution or use on the Union market in a commercial activity, whether paid or free. Placing is the first such making available. Putting into service is the first intended use in the Union. Record the supply facts beside purchase, shipping and commissioning labels, then determine the relevant event. (Article 3(11)–(13))
Treat the transition at product level
Article 51 repeals Directive 2006/42/EC from 20 January 2027. Article 52 protects further making available of products placed on the market in conformity with that Directive before the date. It also states that EC type-examination certificates and approval decisions issued under Article 12 of the Directive remain valid until they expire. The provision includes a market-surveillance transition, so protected earlier placement is not immunity from corrective action. (Articles 51 and 52)
| Situation | Transition question | Record to retain |
|---|---|---|
| Conforming product first placed before 20 January 2027 | Does Article 52 cover this particular product's further supply? | Evidence of compliant earlier placement and the relevant product identity |
| Product first placed on or after 20 January 2027 | Has the Regulation assessment been completed for this product? | Regulation applicability, requirements, assessment and declaration baseline |
| Machinery made for the manufacturer's own use | When is its first intended use in the Union? | Own-use responsibility and putting-into-service facts |
| Existing Directive certificate or approval decision | What does it cover and when does it expire? | Certificate scope, identity and expiry alongside the applicable transition decision |
An earlier sale of the same model does not answer the date question for every later unit. Likewise, a warehouse holding a conforming product already placed before the transition presents a different question from a manufacturer preparing a new unit for its first supply afterwards. The sheet should preserve that distinction.
The principal date is also different from entry into force. Article 54 gives earlier starts for specified provisions. Use its actual application schedule rather than describing all provisions as either already active or wholly deferred to 2027.
Turn the legal transition into an evidence transition
The Directive already required relevant safety compliance, a technical file, information and instructions, conformity assessment, an EC declaration and CE marking before placing machinery on the market or putting it into service. Preparation for the Regulation therefore begins with a controlled comparison of the existing baseline. (Directive Article 5)
Under Regulation Article 10, manufacturers of machinery or related products must address Annex III requirements, prepare Annex IV Part A technical documentation, carry out the relevant Article 25 procedure, then draw up the EU declaration and affix CE marking when conformity has been demonstrated. Article 11 uses a separate route for partly completed machinery, including Annex IV Part B documentation, assembly instructions and an EU declaration of incorporation. (Articles 10 and 11)
Use a transition register to connect each workstream to the actual requirements and evidence affected. The example below is a comparison structure, not a complete technical-file index.
| Workstream | Directive baseline to identify | Regulation review | Evidence transition action |
|---|---|---|---|
| Risk and safety requirements | Annex I applicability and risk assessment | Annex III applicability and risk assessment | Compare hazards, protective measures and residual-risk reasoning |
| Technical documentation | Annex VII Part A or B | Annex IV Part A or B | Review existing material against required content and record gaps |
| Assessment procedure | Article 12 and relevant Directive category | Article 25 and Annex I Part A, Part B or neither | Record category, route and the evidence supporting that choice |
| Declaration | EC declaration or declaration of incorporation | EU declaration of conformity or incorporation | Update legal references and product scope after assessment |
| Instructions | Supplied instructions or assembly instructions | Article 10(7) or Article 11(7) | Review product correspondence, language and delivery format |
| Safety software and data | Existing design and risk evidence | Relevant Annex III 1.1.9 and 1.2.1 requirements | Review identification, protection, interventions and control limits |
Keep an individual row for each material requirement or gap. Add its source locator, affected product configuration, existing evidence reference, proposed disposition, responsible owner and next decision. “Reuse proposed”, “review required” and “new evidence needed” are working states. A file's existence does not establish its adequacy for the new claim.
For a fictional tray-handling cell, a row might connect Annex III 1.1.9 to the identification of safety-critical software. The existing installation record may identify the controller build but leave critical software and data unclassified. The action is to resolve that classification and review the supporting design evidence. A second row might address control-system limits under 1.2.1. Both rows remain open in this teaching example. No product, assessment or test result is being reported.
Annex IV requires risk-assessment documentation, protective measures and relevant residual risks, design information and verification reports or results, among other content. Its sensor-dependent safety-operation provision also calls for appropriate descriptions of system and data capabilities and limitations, and development, testing and validation processes. These requirements explain why renaming the technical-file folder is an inadequate transition task. (Annex IV)
Choose the assessment route before relying on standards
Article 25 separates three category decisions. Annex I Part A uses the listed routes involving EU type-examination followed by conformity to type, full quality assurance or unit verification. Part B permits internal production control only under its specified condition concerning category-specific harmonised standards or common specifications covering all relevant requirements. A category outside Annex I uses internal production control. The product assessment must establish which branch applies. (Article 25)
A catalogue edition, an Official Journal reference and a standard selected in a contract answer different questions. A published edition tells you which document exists. Article 20(1) attaches a presumption of conformity to conformity with harmonised standards or parts whose references have been published in the OJ, and only for the requirements they cover. A contractual edition records the agreed project obligation. Keep all three records where relevant.
The Commission machinery standards page, checked on 21 October 2026, describes its current Directive references and says a Regulation list is being prepared. Its summary is informational and does not itself create legal effects. Before an actual Regulation product assessment, check the published OJ decision, relevant restrictions, covered requirements and dates. The expectation of a future list does not establish the status of any chosen standard.
Keep the AI date and classification decision separate
Regulation (EU) 2026/1744 entered into force on 27 July 2026. Its amendments move the machinery reference to Section B of the AI Act's Annex I and require delegated machinery safety requirements for Article 6(1) high-risk AI, with the delegated acts applying by 2 August 2028. The 20 January 2027 machinery transition is therefore not a universal AI deadline. The actual AI function and use require their own classification and dated-duty assessment. (Amendment Articles 1, 3 and 4, Machinery Article 8)
Start now with one planned delivery. Complete the scope and date sheet, compare its existing requirements and evidence with the Regulation, and assign each unresolved transition row to the person able to close it. That produces a specific readiness decision for a specific product.
For the next engineering step, use the companion guide on turning robot hazards into safety requirements. The existing compliance-matrix guide explains the shared distinction between applicability, a fulfilment position and supporting evidence. Its ECSS obligations are specific to that context.