When talking about EU legislation, the terms ‘Regulation’, ‘Directive’, ‘Communication’, ‘Acts’ and ‘Standards’ are often treated as interchangeable. Spoiler: they are not. Each term tells you how binding a text is and how soon you may need to act.

Regulations are binding in their entirety and apply directly in all Member States, without national transposition. They often apply some years after adoption, so that companies have time to prepare. The Machinery Regulation, the AI Act, the Data Act and the Critical Raw Materials Act are all Regulations, so the same rules apply in Budapest, in Lisbon, and anywhere else in the European Union alike.

Directives set objectives that each Member State must achieve through its own national law by a given deadline. National rules implementing the same Directive can therefore differ in detail, as these instruments allow Member States to regulate up to a certain extent (maximum harmonization), or at least to a certain degree (minimum harmonization). Therefore, we could say that for maximum harmonization, the EU sets a ceiling beyond which national lawmakers cannot regulate, while for minimum harmonization a Directive sets a common basis of rules upon which Member States can legislate according to their needs. Examples relevant to manufacturers include the Right to Repair Directive (EU) 2024/1799, the Product Liability Directive (EU) 2024/2853 and the NIS2 Directive (EU) 2022/2555. 

NB: Always check the national law that implements a Directive in your country. EUR-Lex lists the national transposition measures notified by each Member State.

Communications are not legally binding but provide details on how the EU intends to act on a specific topic (these are usually named Strategy or Action Plan), or, in the case of guidelines, how certain rules should be understood. Examples of recent strategies include the Apply AI Strategy (October 2025), the AI Continent Action Plan (April 2025) and the Competitiveness Compass (January 2025). They often give the first indication of future legislation. In the case of guidelines instead, recent examples include those for the definition of an artificial intelligence system as established by the AI Act, and the guidance on the application of the Cyber Resilience Act. 

NB: Stakeholders can help shape Regulations, Directives and Communications by providing feedback through public consultations and calls for evidence. Published on the Have your say portal, these consultations and calls for input are open to anyone willing to contribute and take place before the relevant Act or Communication is finalised.

Delegated and implementing acts allow the Commission to define the technical details of a law, such as lists, thresholds or procedures. For example, under the Machinery Regulation, the Commission can amend by delegated act the list of machinery in Annex I that requires stricter conformity assessment (Article 6). Notably, following the 2026 amendment of the AI Act, the Commission will also need to adopt a delegated act by 2 August 2028 to integrate the AI Act’s requirements for high-risk AI into the Machinery Regulation.

Harmonised standards translate the essential requirements of EU product legislation into technical specifications. They are developed by the European standardisation organisations (such as CEN, CENELEC and ETSI) upon a request by the Commission. Once the reference of a harmonised standard is published in the Official Journal of the EU, products that comply with it are presumed to meet the requirements it covers. For example, for machinery, EN ISO 12100 sets out the general principles of risk assessment and risk reduction, and other standards deal with specific safety aspects or types of machinery. 

NB: While the technical requirements set out in EU legislation are always mandatory, the use of harmonised standards is usually voluntary. By applying them, manufacturers and service providers can show that their products or services meet EU law requirements. Alternatively, other technical solutions may also be used, provided they achieve the same level of compliance.

The tables below list the EU acts most relevant to machinery and advanced manufacturing, with the dates from which they apply and links to the legal texts and Commission guidance. Whether an act applies depends on the product and on how it is placed on the market, so the tables are a starting point and not legal advice. 

Core product legislation*

Other acts that may apply

* The information reflects the legislation as of September 2026.

• 12 August 2026: the Packaging and Packaging Waste Regulation started to apply.

• 11 September 2026: reporting obligations under the Cyber Resilience Act started to apply. Actively exploited vulnerabilities and severe incidents are reported through ENISA’s Single Reporting Platform.

• 12 September 2026: under the Data Act, newly placed connected products must be designed so that users can access their data.

• 9 December 2026: deadline for Member States to transpose the new Product Liability Directive.

• 20 January 2027: the Machinery Regulation starts to apply and the Machinery Directive 2006/42/EC is repealed.

• 2 December 2027: AI Act requirements start to apply to the high-risk AI systems listed in Annex III.

• 11 December 2027: the Cyber Resilience Act applies in full and the Delegated Regulation (EU) 2022/30 is repealed.

• 2 August 2028: AI Act requirements start to apply to high-risk AI in products covered by the legislation in Annex I. This is also the deadline for the Commission’s delegated act integrating AI requirements into the Machinery Regulation.

The questions below follow the order a manufacturer would normally use to check which EU rules apply to a product. Work through them in sequence and note each ‘yes’. You will end up with a list of acts to examine in more detail, with links to the legal texts and official guidance. For AI systems, the Commission’s AI Act Compliance Checker offers a similar interactive tool.

Q: Is your product machinery?

Article 3(1) of the Machinery Regulation defines machinery as an assembly of linked parts or components, at least one of which moves, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, and joined together for a specific application. The definition also covers assemblies that lack only the connections to the site or to sources of energy, assemblies ready to be installed on a means of transport or in a building, assemblies of machinery that function as an integrated whole, and assemblies that lack only the software needed for their specific application. The Regulation also applies to related products (interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, and removable mechanical transmission devices) and to partly completed machinery.

• If yes: the Machinery Regulation applies from 20 January 2027. Until then, the Machinery Directive 2006/42/EC applies. Continue with step 2 and see ‘What compliance involves’ below.

• If no, or if the product is excluded: the exclusions are listed in Article 2(2). They include spare parts replacing identical components, fairground equipment, machinery specially designed for nuclear purposes, weapons, vehicles covered by EU type-approval rules, means of transport by air, water or rail, seagoing vessels, machinery for military or police purposes, machinery designed for temporary research use in laboratories, mine winding gear, and some electrical and electronic products covered by the Low Voltage Directive or the Radio Equipment Directive (such as household appliances for domestic use, audio and video equipment, IT equipment, ordinary office machinery, low-voltage switchgear and electric motors). For these products, check whether other EU harmonisation legislation applies, such as the Lifts Directive 2014/33/EU, the ATEX Directive 2014/34/EU, the Pressure Equipment Directive 2014/68/EU, the Gas Appliances Regulation (EU) 2016/426, the Personal Protective Equipment Regulation (EU) 2016/425, the Measuring Instruments Directive 2014/32/EU or the Medical Devices Regulation (EU) 2017/745. The full list is on the Commission’s New Legislative Framework page.

If no specific EU legislation applies: the General Product Safety Regulation covers products intended for consumers or likely to be used by them. Products covered only by this Regulation do not bear the CE marking.

Q: Is your product supposed to be used outdoors?

If so, then you should check the Outdoor Noise Directive. The Directive covers 57types of equipment foreseen to be used outdoors, which are listed in Articles 12 and 13 and defined in Annex I OND. In case your product falls within the Directive’s scope, it may be relevant for you to check how to ensure compliance with the requirements included there. Additional guidance is also available.

Q: Can your product connect to a device or network?

If so, it is probably a ‘product with digital elements’ under the Cyber Resilience Act. The manufacturer must design and produce it in line with the essential cybersecurity requirements, handle vulnerabilities throughout the support period and, since 11 September 2026, report actively exploited vulnerabilities and severe incidents. For most products, the manufacturer can assess conformity itself. ‘Important’ and ‘critical’ products listed in Annexes III and IV are subject to stricter procedures. Products covered by certain sectoral rules, such as medical devices and type-approved motor vehicles, are outside the scope.

Q: Does your product use AI?

If so, check whether the AI Act applies, and if so how, given the obligations depend on the nature and classification of the AI system or model, as well as the role of the actor concerned. For machinery, Regulation (EU) 2026/1744 moved the Machinery Regulation from Section A to Section B of Annex I to the AI Act. As a result, the AI Act’s high-risk requirements will not apply to machinery directly. The Commission will integrate them into the Machinery Regulation by delegated act by 2 August 2028. Nevertheless, under the Machinery Regulation, safety components and machinery with fully or partially self-evolving behaviour using machine learning that ensure safety functions are already listed in Annex I, Part A, and require third-party conformity assessment.

Q: Does your product collect or process personal data?

If the product records information about identifiable people, such as operator log-ins, camera images or location data, the General Data Protection Regulation applies to whoever processes, holds or controls the data. Notably, under Article 25, controllers must apply data protection by design and by default. Recital 78 encourages producers to take this into account when designing products, which makes it easier for customers to use them lawfully.

Q: Does your product generate data that it can share?

A product that obtains data on its use or environment and can communicate it is a ‘connected product’ under the Data Act. Users, including business users of industrial machinery, have the right to access this data and to have it shared with third parties. Connected products placed on the market after 12 September 2026 must be designed so that users can access the data directly, where relevant and technically feasible.

Q: Requirements that apply across products

• Product liability: the Product Liability Directive applies to all products, including software and digital manufacturing files.

• Packaging: packaging placed on the EU market must comply with the Packaging and Packaging Waste Regulation.Digital Product Passport: required once an ESPR delegated act covers your product group. Some legislation already provides for a passport, such as the Batteries Regulation for certain batteries from 18 February 2027. See the ESPR Working Plan.

• Chemicals: if your product contains substances of concern, check your obligations under REACH.

• Cybersecurity of your organisation: check whether your company is covered by the NIS2 Directive or supplies companies that are.

• Data sharing: check whether the Data Governance Act offers a way to share data through a trusted intermediary.

• Opportunities: check whether your project could benefit from the Net-Zero Industry Act, the Critical Raw Materials Act or STEP.

Most EU product legislation follows the same approach, described in the Commission’s Blue Guide on the implementation of EU product rules (2022). The Machinery Directive 2006/42/EC applies until 19 January 2027. For machinery placed on the market until then, the main steps are as follows.

• Check the scope: confirm that the product is machinery, interchangeable equipment, a safety component, a lifting accessory, chains, ropes or webbing, a removable mechanical transmission device or partly completed machinery as defined in Article 2 of the Machinery Directive, and that it is not excluded under Article 1(2).

• Carry out a risk assessment: identify the hazards of the machinery, taking into account its intended use and any reasonably foreseeable misuse, and determine which essential health and safety requirements in Annex I apply. Then design and build the machinery to eliminate or reduce the risks in line with those requirements.

• Apply harmonised standards: identify the harmonised standards whose references have been published in the Official Journal under the Directive, such as EN ISO 12100. Machinery built in line with them is presumed to meet the essential requirements they cover (Article 7).

• Choose the conformity assessment procedure (Article 12): for machinery not listed in Annex IV, the manufacturer carries out internal checks on manufacture (Annex VIII). For the categories of machinery listed in Annex IV, if harmonised standards covering all the relevant essential requirements have been fully applied, the manufacturer may choose between internal checks (Annex VIII), EC type-examination (Annex IX) plus internal checks, or full quality assurance (Annex X). If such standards have not been applied, have been applied only in part, do not cover all the relevant essential requirements or do not exist, the manufacturer must use EC type-examination (Annex IX) plus internal checks, or full quality assurance (Annex X). Both procedures involve a notified body. Notified bodies are listed in the NANDO database.

• Compile the technical file: prepare the technical file described in Annex VII, Part A. It includes, among other things, a general description of the machinery, drawings and calculations, test results, the risk assessment documentation, the standards applied, a copy of the instructions and a copy of the EC declaration of conformity. Keep it available to national authorities for at least 10 years following the date of manufacture of the machinery or, for series production, of the last unit produced.

• Prepare the instructions: all machinery must be accompanied by instructions in the official language or languages of the Member State in which it is placed on the market or put into service, with the content set out in section 1.7.4 of Annex I.

• Draw up the EC declaration of conformity and affix the CE marking: draw up the EC declaration of conformity (Annex II, Part 1, Section A), make sure it accompanies the machinery, and affix the CE marking (Article 16 and Annex III) before placing the machinery on the market or putting it into service.

• Partly completed machinery: it does not bear the CE marking. Instead, the manufacturer prepares the relevant technical documentation (Annex VII, Part B), assembly instructions (Annex VI) and a declaration of incorporation (Annex II, Part 1, Section B), as set out in Article 13.

From 20 January 2027, the Machinery Regulation replaces the Directive. The main steps remain similar, but the annexes and some requirements change, as follows.

• Risk assessment: identify the hazards of the machinery, taking into account its intended use and any reasonably foreseeable misuse. Then eliminate or reduce the risks in line with the essential health and safety requirements in Annex III.

• Conformity assessment: machinery listed in Annex I, Part A must be assessed with the involvement of a notified body, through EU type-examination, full quality assurance or unit verification. Part A has six categories, including safety components and machinery with self-evolving behaviour using machine learning that ensure safety functions. For machinery in Annex I, Part B, the manufacturer may use internal production control if it has fully applied harmonised standards or common specifications. Otherwise, a notified body must be involved. All other machinery can be assessed by the manufacturer. Notified bodies are listed in the NANDO database.

• Technical documentation: prepare the technical file described in Annex IV. It includes, among other things, a description of the machinery, drawings, the risk assessment, the standards applied, test reports and the instructions. Keep it for at least 10 years after the machinery is placed on the market.

• EU declaration of conformity and CE marking: draw up and sign the EU declaration of conformity and affix the CE marking before placing the product on the market. Where several EU acts requiring a declaration apply, a single declaration covers all of them. More information is available on Your Europe.

• Instructions: instructions for use may be supplied in digital form. If the user asks for a paper copy at the time of purchase, the manufacturer must provide it free of charge within one month. For machinery intended for non-professional users, the safety information needed to put the machinery into service and use it safely must always be supplied on paper. Digital instructions must remain available online for the expected lifetime of the machinery and for at least 10 years after it is placed on the market.

• After placing on the market: cooperate with market surveillance authorities and take corrective action if the product does not comply. Anyone who substantially modifies machinery after it has been placed on the market is considered its manufacturer and takes on the manufacturer’s obligations.

Obligations under other acts, such as vulnerability handling under the Cyber Resilience Act or data access under the Data Act, apply in parallel. Proposals to digitalise the declaration of conformity and instructions across EU product legislation (the ‘Omnibus IV’ package) were provisionally agreed by the European Parliament and the Council in June 2026. Check whether they have been formally adopted before relying on them.

• Your Europe Business: practical guidance on product requirements and CE marking, with contacts for national assistance services.

• EUR-Lex summaries: short summaries of EU legislation, including the Machinery Regulation.

• AI Act Service Desk: the Compliance Checker, the AI Act Explorer and a form for questions to the AI Office.

• Cyber Resilience Act: a summary of the Regulation and guidance on reporting obligations.

• NANDO database: notified bodies by legislation and conformity assessment procedure.

This section contains the policies and legal acts themselves and is updated when the law changes. Ongoing developments, such as new proposals, calls for evidence or political agreements, are covered in What’s new. To follow a proposal through the legislative process, use the European Parliament’s Legislative Train.