Introduction

The machinery sector is one of the most important and innovative sectors in the European Union (EU), contributing to the competitiveness, growth, and employment of the EU economy. According to the latest statistics, the sector employs more than 2.7 million people and generates a turnover of over 700 billion euros, accounting for about 27% of the EU’s manufacturing output and 15% of the EU’s exports. The sector is also a key driver of technological development and digital transformation, as it produces and uses advanced technologies such as artificial intelligence, internet of things, robotics, and cybersecurity.

However, the sector also faces several challenges, such as the increasing complexity and diversity of machinery and related products, the rapid technological changes and digitalisation, the environmental and social impacts, and the global competition. These challenges pose new risks and opportunities for the health and safety of the users and operators of machinery and related products, as well as for the functioning and competitiveness of the internal market. Therefore, it is essential to have a clear and consistent legal framework that ensures a high level of protection for the health and safety of persons, domestic animals, property, and the environment, and that facilitates the free movement of products in the internal market, while fostering the innovation and sustainability of the sector.

To address these challenges and to modernise and harmonise the legal framework for the design and construction of machinery and related products, the EU has adopted a new regulation on machinery products, which will enter into force on 20 January 2027. The new regulation replaces the previous directive on machinery, which was adopted in 2006 and had become outdated and insufficient to cope with the current and future developments and needs of the sector.

The new regulation aims to achieve the following objectives and benefits:

To improve the health and safety of the users and operators of machinery and related products, by setting out clear and comprehensive essential health and safety requirements that reflect the technological developments and the state of the art, and by providing effective and efficient conformity assessment procedures and market surveillance and enforcement mechanisms.
To enhance the competitiveness and innovation of the machinery sector and the EU economy, by providing a level playing field and a single set of rules for all economic operators, by facilitating the free movement of products in the internal market, and by encouraging the adoption of new technologies and solutions that offer better value for money and higher performance.
To support the sustainability and resilience of the machinery sector and the EU economy, by promoting the circular economy and the green transition, by reducing the environmental and social impacts of machinery and related products, and by increasing the preparedness and responsiveness to unforeseen events and crises.

The new regulation will have significant implications and impacts on the different types of machinery and related products, and on the various actors in the supply chain, such as manufacturers, importers, distributors, and users. Therefore, it is important to understand the changes and challenges that the regulation will bring, and to prepare accordingly. This white paper aims to provide an overview of the main features and requirements of the new regulation, and to offer practical guidance and recommendations for the stakeholders involved in the design, manufacture, import, distribution, and use of machinery and related products in the EU.

Is there a transition Period?

The EU Machinery Regulation will not apply immediately, but after a transition period of 42 months from its entry into force, which was 20 days after its publication in the EU Official Journal. The transition period will end on 20 January 2027 (key date regulation).

During the transition period, there will be no option to choose between the old and the new rules. The transition period is meant to give enough time for manufacturers to adjust to the new rules, and to switch to them on the exact day. For instance, from 20 January 2027, declarations of conformity must follow the new EU Machinery Regulation.

There is a special case for products that were declared under the Machinery Directive before the key date of 20 January 2027, but then remained in stock for some time and were only used in an actual application later. In this case, there is no need to ask the product manufacturer for a new declaration of conformity, as the product was already on the market. The situation may be more ambiguous when products are in stock after the key date at the original manufacturer, have not been sold, and therefore have not been “on the market”. In this case, the new rules apply from the specified key date.

A Summary of Key Changes

Scope	Covered machinery, interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, removable mechanical transmission devices, and partly completed machinery	Same as the previous directive, plus small vehicles used for personal transport and light electric vehicles such as scooters or bikes
Legal form	Directive, requiring transposition into national law by Member States	Regulation, directly applicable in Member States without transposition
Essential health and safety requirements (EHSRs)	Set out in Annex I of the directive, divided into six sections	Set out in Annex III of the regulation, divided into six sections, with some revisions, clarifications, or additions to reflect the technological developments and the state of the art, such as new EHSRs on autonomous mobile machinery, artificial intelligence, cybersecurity, and ergonomics
Conformity assessment procedures	Provided three main routes for conformity assessment, depending on the type and category of the product: the internal production control, the EC-type examination plus internal production control, and the full quality assurance	Provides three main routes for conformity assessment, similar to those of the previous directive, but some have been simplified, harmonised, or updated, such as the abolition of the EC declaration of conformity and the replacement with the EU declaration of conformity, which has a standardised format and content
Obligations of economic operators	Defined and clarified the role and tasks of manufacturers, authorised representatives, importers, and distributors	Same as the previous directive, plus introduces some new obligations, especially for fulfilment service providers, who are involved in online sales of products, and requires that every product has an economic operator established in the Union who is responsible for ensuring the availability of the technical documentation, the conformity of the product, the cooperation with the market surveillance authorities, and the corrective measures in case of non- compliance
Market surveillance and enforcement mechanisms	Provided measures and actions for the competent authorities of the Member States to monitor and ensure the compliance of products on the market or in service and to deal with non- compliant or unsafe products	Strengthens and harmonises the market surveillance and enforcement mechanisms by providing more powers and tools for the authorities, such as the possibility to carry out online checks, to request information from economic operators, to impose penalties, to order recalls or withdrawals, and to destroy non- compliant products, and enhances the cooperation and coordination among the authorities, both at national and EU level, by establishing a single liaison office in each Member State, a Union Product Compliance Network, and a database for information exchange
Role of standards and common specifications	Recognised the importance and value of harmonised standards and common specifications as voluntary means to achieve the presumption of conformity with the directive	Same as the previous directive, plus introduces some changes and improvements in the development, adoption, and use of standards and common specifications, such as the possibility for the Commission to request the development of standards on specific topics, the establishment of a consultation forum for stakeholders, and the publication of references of harmonised standards and common specifications in the Official Journal of the European Union

Topic	Previous Directive	New Regulation
Scope	Covered machinery, interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, removable mechanical transmission devices, and partly completed machinery	Same as the previous directive, plus small vehicles used for personal transport and light electric vehicles such as scooters or bikes
Legal form	Directive, requiring transposition into national law by Member States	Regulation, directly applicable in Member States without transposition
Essential health and safety requirements (EHSRs)	Set out in Annex I of the directive, divided into six sections	Set out in Annex III of the regulation, divided into six sections, with some revisions, clarifications, or additions to reflect the technological developments and the state of the art, such as new EHSRs on autonomous mobile machinery, artificial intelligence, cybersecurity, and ergonomics
Conformity assessment procedures	Provided three main routes for conformity assessment, depending on the type and category of the product: the internal production control, the EC-type examination plus internal production control, and the full quality assurance	Provides three main routes for conformity assessment, similar to those of the previous directive, but some have been simplified, harmonised, or updated, such as the abolition of the EC declaration of conformity and the replacement with the EU declaration of conformity, which has a standardised format and content
Obligations of economic operators	Defined and clarified the role and tasks of manufacturers, authorised representatives, importers, and distributors	Same as the previous directive, plus introduces some new obligations, especially for fulfilment service providers, who are involved in online sales of products, and requires that every product has an economic operator established in the Union who is responsible for ensuring the availability of the technical documentation, the conformity of the product, the cooperation with the market surveillance authorities, and the corrective measures in case of non- compliance
Market surveillance and enforcement mechanisms	Provided measures and actions for the competent authorities of the Member States to monitor and ensure the compliance of products on the market or in service and to deal with non- compliant or unsafe products	Strengthens and harmonises the market surveillance and enforcement mechanisms by providing more powers and tools for the authorities, such as the possibility to carry out online checks, to request information from economic operators, to impose penalties, to order recalls or withdrawals, and to destroy non- compliant products, and enhances the cooperation and coordination among the authorities, both at national and EU level, by establishing a single liaison office in each Member State, a Union Product Compliance Network, and a database for information exchange
Role of standards and common specifications	Recognised the importance and value of harmonised standards and common specifications as voluntary means to achieve the presumption of conformity with the directive	Same as the previous directive, plus introduces some changes and improvements in the development, adoption, and use of standards and common specifications, such as the possibility for the Commission to request the development of standards on specific topics, the establishment of a consultation forum for stakeholders, and the publication of references of harmonised standards and common specifications in the Official Journal of the European Union

Essential health and safety requirements (EHSRs)

The essential health and safety requirements (EHSRs) are the core of the regulation, as they specify the objectives to be achieved by the design and construction of machinery and related products in order to ensure a high level of protection for the health and safety of persons, domestic animals, property, and the environment.

The EHSRs are set out in Annex III of the regulation and are divided into six sections: general principles:

Requirements for certain categories of machinery,
Requirements related to the mobility of machinery,
Requirements related to lifting operations,
Requirements for machinery intended for underground work,
Requirements for machinery lifting

The EHSRs are largely based on those of the previous directive, but some have been revised, clarified, or added to reflect the technological developments and the state of the art.

For example, the regulation introduces new EHSRs on autonomous mobile machinery, artificial intelligence, cybersecurity, and ergonomics.

Conformity assessment procedures

These are the methods by which manufacturers or other economic operators demonstrate that their products comply with the EHSRs and other relevant provisions of the regulation.

The regulation provides three main routes for conformity assessment, depending on the type and category of the product:

the internal production control,
the EU-type examination plus internal production control
full quality assurance

The conformity assessment procedures are similar to those of the previous directive, but some have been simplified, harmonised, or updated to improve their effectiveness and efficiency. For example, the regulation abolishes the EC declaration of conformity and replaces it with the EU declaration of conformity, which has a standardised format and content.

Obligations of economic operators

These are the responsibilities and duties that manufacturers, authorised representatives, importers, distributors, and fulfilment service providers have to fulfil in order to ensure that only compliant and safe products are made available on the market or put into service. The regulation defines and clarifies the role and tasks of each economic operator and introduces some new obligations, especially for fulfilment service providers, who are involved in online sales of products. For example, the regulation requires that every product has an economic operator established in the Union who is responsible for ensuring the availability of the technical documentation, the conformity of the product, the cooperation with the market surveillance authorities, and the corrective measures in case of non-compliance.

Market surveillance and enforcement mechanism

These are the measures and actions taken by the competent authorities of the Member States to monitor and ensure the compliance of products on the market or in service and to deal with non-compliant or unsafe products. The regulation strengthens and harmonises the market surveillance and enforcement mechanisms by providing more powers and tools for the authorities, such as the possibility to carry out online checks, to request information from economic operators, to impose penalties, to order recalls or withdrawals, and to destroy non-compliant products. The regulation also enhances the cooperation and coordination among the authorities, both at national and EU level, by establishing a single liaison office in each Member State, a Union Product Compliance Network, and a database for information exchange.

Roles of standards and common specifications

The role of standards and common specifications is to provide technical solutions and guidance for the implementation of the EHSRs and other requirements of the regulation. The regulation recognises the importance and value of harmonised standards and common specifications as voluntary means to achieve the presumption of conformity with the regulation. The regulation also introduces some changes and improvements in the development, adoption, and use of standards and common specifications, such as the possibility for the Commission to request the development of standards on specific topics, the establishment of a consultation forum for stakeholders, and the publication of references of harmonised standards and common specifications in the Official Journal of the European Union.

Implications of the New Regulation

The new regulation on machinery and related products will have significant implications and impacts on the different types of machinery and related products, and on the various actors in the supply chain, such as manufacturers, importers, distributors, and users. The regulation will introduce new requirements and obligations, but also new opportunities and benefits, for the machinery sector and the EU economy. Therefore, it is important to understand the changes and challenges that the regulation will bring, and to prepare accordingly.

Some of the practical recommendations and guidance on how to comply with the regulation and how to take advantage of the opportunities it offers are:

For manufacturers:

Ensure that the design and construction of machinery and related products comply with the essential health and safety requirements and other relevant provisions of the regulation.
Conduct a risk assessment and choose the appropriate conformity assessment procedure for each product.
Prepare the technical documentation and the EU declaration of
Affix the CE marking and provide the instructions for use in digital
Cooperate with the market surveillance authorities and take corrective measures in case of non-compliance.
Keep up to date with the technological developments and the state of the art, and follow the standards and common specifications that provide technical solutions and guidance for the implementation of the
Innovate and differentiate your products by incorporating new technologies, such as artificial intelligence, internet of things, and robotics, and ensure their safety and security.

For importers:

Verify that the machinery and related products you intend to place on the market have undergone the conformity assessment procedure and bear the CE marking.
Ensure that the manufacturer has prepared the technical documentation and the EU declaration of conformity, and that they are available upon
Provide your contact details on the product or on the accompanying documents.
Cooperate with the market surveillance authorities and take corrective measures in case of non-compliance.
Check the compliance of the products with other applicable EU legislation, such as the REACH regulation or the RoHS directive.
Seek reliable and trustworthy suppliers that can guarantee the quality and safety of the products.

For distributors:

Before making the machinery and related products available on the market, check that they bear the CE marking and are accompanied by the instructions for use and the EU declaration of Do not supply products that you know or should have presumed to be non-compliant.
Cooperate with the market surveillance authorities and take corrective measures in case of non-compliance.
Provide the contact details of the manufacturer, the authorised representative, or the importer upon request. Inform the customers about the digital format of the instructions for use and offer the paper format if requested.
Promote the products that offer the best value for money and the highest level of safety and performance.

For users:

Before using the machinery and related products, read the instructions for use carefully and follow the safety precautions and recommendations.
Check that the products bear the CE marking and are accompanied by the EU declaration of conformity. Report any incidents or accidents involving the products to the manufacturer, the distributor, or the market surveillance
Provide feedback and suggestions to the manufacturer or the distributor on how to improve the products. Benefit from the increased choice and quality of the products on the market, and the enhanced protection of your health and safety.

Conclusion

The new regulation on machinery and related products is a major achievement for the EU, as it will modernise and harmonise the legal framework for the design and construction of machinery and related products, and ensure a high level of health and safety for the users and operators of such products. The regulation will also foster the competitiveness, innovation, and sustainability of the machinery sector and the EU economy, by providing a clear and consistent set of rules and requirements, by facilitating the free movement of products in the internal market, and by encouraging the adoption of new technologies and solutions. The regulation will enter into force on 20 January 2027, and will apply to all machinery and related products that are placed on the market or put into service from that date. Therefore, it is essential that all the stakeholders involved in the machinery sector, such as manufacturers, importers, distributors, and users, are aware of the changes and challenges that the regulation will bring, and are prepared to comply with the regulation and to take advantage of the opportunities it offers.

This white paper has provided an overview of the main features and requirements of the regulation, and has offered practical guidance and recommendations for the stakeholders. However, this white paper is not exhaustive, and does not cover all the aspects and details of the regulation. Therefore, we invite the readers to consult the full text of the regulation, and to contact us for any further information or assistance.