In January 2027, a new EU Machinery Regulation (2023/1230) will come into force to replace the EU Machinery Directive (2006). It will bring changes for equipment manufacturers, suppliers, and owners. We sat down with our in-house regulatory and industry expert, Lars Erik Vågen, to ask him about the changes and what they mean for stakeholders in the equipment and machinery industry.
Read below for his answers to some key questions including what the changes are, who they affect and how to prepare.
The EU Machinery Regulation 2023/1230 is a piece of legislation that sets requirements for the design and construction of machinery placed on the European market. Its objective is to ensure that products sold and used within the EEA are in conformity with the minimum quality requirements, and are accompanied by the correct documentation to protect the health and safety of users.
The EU machinery Regulation 2023/1230 replaces the EU Machinery Directive 2006/42/EC.
After its introduction in 2023, the EU Machinery Regulation is intended as a replacement of the Machinery Directive 2006/42/EC. As common practice with EU legislation, there is a grace period of three years before new legislation is binding. This grace period gives member countries time to prepare for new laws.
The grace period for the EU Machinery Regulation ends on January 1st, 2027. That means that adherence to the Regulation becomes mandatory in all EEA states.
The hard deadline for businesses operating within those states is set to January 20th, 2027.
An EU directive is legislation that needs to be transposed into national legislations, before it is applicable in member states and EEA countries.
An EU regulation is a piece of legislation that is directly applicable in all EU member states and three EFTA countries that make up the EEA (Iceland, Liechtenstein and Norway).
This means a regulation is one universally enforced legislation across nations, whereas a directive is implemented through individual national laws and can be adapted by local governance.
The Machinery Regulation applies to any business/entity/person who manufacturers, imports, sells, owns or uses work equipment within the EEA (EU + Iceland, Liechtenstein and Norway).
The Regulation will automatically apply in all EEA countries.
Yes. Norway is an EEA member, so the Regulation is automatically applicable from January 20th, 2027.
The Machinery Regulation covers machinery, partly completed machinery and related products including interchangeable equipment, safety components, lifting accessories, chains, ropes, webbing and removable transmission devices (Article 2).
This list, along with a list of items not covered by the Regulation, can be found in the scope of the regulation as set out in article 2. Definitions, including machinery and related products, can be found in article 3 of the legislation.
The Machinery Regulation is not a huge departure from the Machinery Directive (2006/42/EC) that it replaces.
The updates implemented through the regulation focus on clarifying complex issues, specifying where responsibility lies and expanding scope to include digital processes, robotics and AI.
Key themes in the legislation include:
The key changes for machinery and equipment manufacturers relate to labelling of products, digital documentation formats and a full lifetime approach.
The Machinery Regulation requires manufacturers to add the manufacturer's address to the product label as well as a link to a digital documentation database or the manufacturer's webpage, where space allows. This is an additional requirement to the Machinery Directive which requires labelling with manufacturer, type, model and weight class. These requirements still apply as of January 2027.
These requirements are a significant change for manufacturers. The Machinery Regulation requires that the Declaration of Conformity (DOC) be made available in a digital format. A paper version can be provided in addition. This means manufacturers will need to start digitalizing documentation and finding a way to deliver it to customers. It also points to a wider transition towards fully digital documentation packages which is supported by the requirement for digital links on products.
Another thing to mention is the implementation of a new requirement, where the regulation now requires the manufacturer to have performed safety evaluations of the product. This evaluation shall take into consideration transport, installation, use, disassembly, destruction/recycling. In addition, this evaluation shall be stored digitally and made available to the appropriate legislative enforcement agencies in the full lifetime of the equipment, or 10 years, whichever ends later.
Approaches to document storage requirements have also changed. Lifetime of a product no longer stops at end of service. Instead, manufacturers must consider full end of life scope including dismantling and destruction. As a result, documentation storage requirements have also changed. Manufacturers must now keep on file product documentation for its full lifetime or 10 years, whichever ends later.
The new Machinery Regulation places a more clearly defined responsibility for correct documentation handling on importers and distributors of equipment.
Importers that bring products into the EEA assume full responsibility for documentation on the same level as any manufacturer of European made products. They must ensure that equipment is compliant with European laws and regulations before sale. This means having the correct documentation, in the correct formats, and in a language understandable to the market it is sold to.
Distributors are the entity that conveys the product to the end user. They also share responsibility for correct documentation and formatting.
For both these actors, it is an explicit infringement of the regulation to sell or forward any equipment that does not have the correct documentation package. This is a hard tightening up of the law that places explicit responsibility on suppliers and removes the excuse that a product is produced elsewhere so responsibility lies elsewhere, or that the equipment users are trained in the use of the equipment and therefore don't need the documentation.
For equipment owners and users that receive equipment, the Machinery Regulation both strengthens rights and responsibilities.
Equipment owners are now able to push suppliers to provide the correct documentation. That means missing documentation should no longer be a problem as suppliers are responsible and purchasers have the right to push back if requirements are not met. This includes for digital documentation. With a digital DOC requirement and implications that digital documentation is the way forward, equipment owners can gain better control of documentation. Requiring delivery of documentation through a document management system like Onix means all compliance documentation will be available from day one. No more risk of missing documentation and the potential consequences of operational shutdown and fines.
Responsibilities do also increase for equipment owners. They must pass on this accessibility of documentation to their workers, the equipment users. Previously it was a requirement through national legislation to provide access to user manuals. Now it is a requirement under EU legislation that all safety information including user manuals and original certification are made accessible to users. Furthermore, the requirement is also that upon inspection, maintenance, or modification, the documentation of such action shall immediately be made accessible to the user. This in turn puts an additional pressure on companies to employ a dedicated system, like Onix, that lets workers easily access the equipment documentation.
The changes indicate that this may be likely in the future. The EU stages major changes to enable member states and businesses working under their jurisdiction to react.
Requirements for a digital DOC can be seen as a first step towards a full digital documentation package.
The new regulation opens the doors for full digital equipment management that is in line with wider EU trends towards digital product lifecycle tracking as seen in the DPP initiative. Requirements for QR codes and links to digital databases also indicate preparations for a transition to paperless equipment compliance management.
However, EU policy is clear that these changes take time given factors such as varying internet coverage, so we should expect changes to be gradual and grace periods to be long.
For suppliers, the short answer is yes, if that equipment is within your normal business scope.
If you supply equipment to a certain region, you must ensure that customers receive documentation in a language that they understand.
If the equipment falls out of your usual scope, for example a pipe supplier selling an individual cable drum, then another language such as English can be acceptable, given that this is a "one-off" trade akin to a special order, and that the translation itself can be considered an unacceptable financial burden.
However, new AI tools are very good at making translations of documents today, so I would personally employ those types of tools to do the translation for me. Most documents can today be translated by AI in a matter of minutes, so there is really no good excuse anymore.
Equipment owners must always ensure that documentation is available to end users in a language the end user can understand.
For example, an employer in Norway must ensure that a crane driver that only speaks Italian, receives user manuals and original documentation for that crane and its associated equipment in Italian.
My short answer is to start early.
Manufacturers and suppliers need to be ready to produce and distribute digital DOCs and full documentation packages on January 1st, 2027. This means establishing processes ahead of time and preparing so that documentation systems aren’t complicated by batches with deliveries on either side of the implementation date.
My advice would be to start setting up the system now and trial with certain products so that you have any issues ironed out by January. Leaving things too late could be complex and costly.
Onix is a ready-to-go system that can be used by all equipment stakeholders (manufacturers, suppliers, owners and users) to manage track and share equipment data and documentation. It handles the whole document transfer process from manufacturer to end user. It also acts as a live database with a complete history for each equipment item’s full lifetime.
With Onix, manufacturers can create digital documentation packages for equipment that are tied to batch numbers. This automates processes and prevents time consuming repeat document work. These documents are delivered instantly into customer accounts, and records are stored for the full period required by the Machinery Regulation.
QR and RFID codes from Onix Tags mean that manufacturers can add required labelling to products that gives customers instant documentation access. Equipment owners can also pass on this accessibility to users with no extra work. All that’s needed is a smartphone to scan the tag and access all legally required documentation. No documentation is ever locked behind a paywall, as long as you have physical access to the equipment and a smartphone or tablet.
Onix offers a simple solution to digital documentation requirements throughout the equipment lifecycle. By implementing a digital equipment management system today, all stakeholders in the value chain can get ahead of EU digitalization requirements while saving time and costs for their businesses.
My top tip would be not to be afraid of looking up regulations.
They may seem complex, but there are a lot of resources out there from national bodies that can help you to prepare for changes, protect your business and engage with industry discussion. Using resources such as www.en-standard.eu and eur-lex.europa.eu can help you stay up to date and prioritize compliance matters.
In relation to the Machinery Regulation, my top tip would be to know your rights and responsibilities. Be vigilant and push documentation responsibilities to suppliers and manufacturers when necessary. At the same time, make sure you are making documentation and safety information accessible to your stakeholders. If you do so with a digital system, you can save time, cost and worry.
There are regularly made changes to laws and regulations that can affect your business. With the AI tools of today, there exist fantastic opportunities to use these to set up automatic monitoring functions of the sources mentioned in this QA, and have the AI regularly check for changes and provide a summary based on your exact business case.