The introduction of a ‘regulation’ means that it must be applied in the same way in all member states. Unlike directives, which require national implementation, this regulation is directly applicable in all EU member states and becomes directly valid and legally binding from 20 January 2027. Such uniformity eliminates potential inconsistencies and ensures a level playing field for manufacturers and importers.
CHAPTER 1 - GENERAL PROVISIONS
For products within the scope of the regulation and specific union harmonisation legislation, this chapter includes details on the subject matter, scope, definitions, free movement, as well as protection of persons during installation or use of machinery or related product. It also includes categories of machinery and related products listed in Annex I subject to relevant conformity assessment procedures, safety components, and essential health and safety requirements (EHSRs).
The main changes within Chapter 1, which have practical implications compared to the old Machinery Directive are outlined below.
EXPANDED SCOPE AND BROADER DEFINITION
The regulation provides clarity on the definitions, which have been expanded. It now includes any assembly with a drive system (other than direct human or animal effort) designed for a specific application. This broader scope encompasses various products, including those with embedded software. This clarity helps manufacturers, importers and distributors understand whether their products fall under the regulation and provides a parallel tendency towards horizontal legal acts, such as the Cyber Resilience Act and AI-act, etc.
ANNEX 1
Categories of machinery and related products in Annex I are now subject to relevant conformity assessment procedures. This new Annex 1 is essentially the old Machinery Directive Annex IV. However, the new Annex 1 has been segregated into parts A and B. A good way to think of this is that while machine groups within Annex 1 are classed as ‘high risk’ machinery, those within Annex 1 Part A are classed as ‘very high risk’.
The whole list is the same as Annex IV, but with an additional two groups of machinery being created and placed within Annex 1.A, with this section containing a total of six machine groups. The four original groups are: removable mechanical transmission devices including their guards; guards for removable mechanical transmission devices; vehicle servicing lifts and portable cartridge-operated fixing and other impact machinery.
The two new groups of machinery are: safety components with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions and machinery that has embedded systems with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions that have not been placed independently on the market, in respect only of those systems.
The new Machinery Regulation has mandated that all machinery listed within Annex 1.A above must receive a conformity assessment from a Notified Body. The practical implication of this is that manufacturers will need to consider applying for and carrying out these conformity assessments before the transition date to ensure that market access of these goods is not un-hindered. Consideration should therefore be given to the availability of Notified Bodies to perform these assessments. So, don’t wait too long before applying for third party conformity assessment.
High risk machinery groups within Annex 1.B can continue to be self-certified (internal production control – module A) by the manufacturer. The machinery or related product must be designed and constructed in accordance with the harmonised standards, or common specifications specific to that category of machinery or related product which cover all the relevant EHSRs without deviation.
In additions to Notified Body Conformity Assessment by type-examination (module B) or Full Quality Assurance (module H), the Machinery Regulation also includes Unit Verification (module G). It also stipulates separately the requirement for an ongoing responsibility for conformity assessment by the manufacturer through ‘conformity to type based on internal production control (module C)’. So, essentially type-examination is specifically for ‘series manufacture’ and Unit Verification for one-off builds.
MANUFACTURER, IMPORTER AND DISTRIBUTOR OBLIGATIONS
The scope of the new Machinery Regulation has also been expanded in comparison to its predecessor, as it spans the entire supply chain and specifies concrete obligations for all market participants. Chapter two of the regulation provides clarity on the legal obligations of economic operators and now includes importers, distributors, and natural or legal persons who have carried out substantial modifications. Listed below are some of the main aspects to be aware of.
MANUFACTURER
Technical Documentation and EU Declaration of Conformity (DofC) must be stored for a minimum of 10 years after the last type of machine is placed into the EU market. The marking of the machine now must now also contain a digital contact detail, such as website or email. It must also remain valid and online for 10 years from the last machine of the type being placed onto the market.
The ‘professional use’ machinery instructions for use and information must be made available digitally and marked directly on the machine to allow digital access, such as via QR code – and the same for the DofC. For machines where it is foreseeable that non-professionals will be the user, then hard copy instructions and DofC must also be provided.
For partly completed machinery the same requirements remain, but access to the Declaration of Incorporation (DofI) is provided digitally instead of the DofC.
It’s important to note that anyone who makes a ‘substantial modification’ to a machinery is considered a manufacturer and must therefore fulfil all obligations associated with this role. The Machinery Regulation also further clarifies what is meant by the substantial modification of products.
AUTHORISED REPRESENTATIVE
The authorised representative shall not be mandated for the design and construction of the machine or for drawing up the technical file. The minimum tasks of the authorised representative are to keep the technical documentation (Annex IV) and the EU DofC/DofI for a minimum of 10 years after placing the machinery onto the market. They must also interact and co-operate with authorities in cases of a request.
IMPORTER
‘Importer’ means any natural or legal person established within the EU who places a product within the scope of this regulation from a third country on the market – and they must place only compliant machinery on the market. While storing or transporting the machinery, they must ensure they do not jeopardise any EHSRs. They must also verify that conformity assessments have been carried out, and ensure that machinery has the required technical documentation, CE marking and instructions.
Importers must not place products on the market that they believe to not be in conformance with the Regulation, and they must inform both the manufacturer as well as the market surveillance authorities regarding any cases of risk to health and safety.
As well as ensuring that technical documentation is available, importers must also store copies of DofCs for 10 years. Where deemed appropriate, they are also required to perform, or have carried out, sample testing of products. Where necessary, importers must also maintain a register of complaints and keep distributors informed, where required. They may also be required to take corrective actions to recall non-conforming products from the market and inform local authorities and the manufacturer. They will also be responsible for interacting and cooperating with authorities in the case of any requests. Machinery must also be marked with their importer details. This should include name, postal address, website and email, which means that machinery could have two sets of markings.
DISTRIBUTOR
‘Distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product within the scope of this Regulation available on the market. Distributors shall act with due care in relation to Regulation requirements, and verify that certain requirements, such as CE marking, DofC, instructions for safe use – and safety information are available digitally or where required also supplied in hard copy with the machinery.
While storing or transporting the machinery, distributors must also ensure they do not jeopardise any EHSRs. Where required, they must take corrective actions to recall non-conforming products from the market, and inform local authorities and the manufacturer. They are also required to interact and cooperate with authorities in the case of requests.
Something that must be noted here is that an end user of a machine, could also be the importer of the machine, for example an employer within Ireland orders a machine from China directly to be installed on their shop floor. That employer now assumes the role of importer.
NEW REGULATION
Within the Regulation, some terminology has also changed, particularly as there was often confusion as the Machinery Directive used the generic term ‘machinery’. The new regulation instead refers to ‘machinery and related products’ and defines the term ‘machine’ separately from ‘related products’. This means that there should now be no room for confusion when undertaking a conformity assessment.
While the Regulation has entered into force throughout all EU Member States, it does have a transition period of three years, after which its application becomes mandatory. This means that the new requirements must be applied from 20 January 2027.
In our experience, the lengthy transitional period means that the majority of manufacturers will be slow to begin addressing the new requirements. However, as implementation is likely to be a time-consuming process, companies affected by the new Regulation are strongly advised to waste no time and start tackling it now.
In conclusion, the enactment of the Machinery Regulation 2023/1230 heralds significant changes and obligations for economic operators within the EU machinery industry. Compliance with these regulations is crucial, not only for ensuring the safety and quality of machinery and related products, but also for fostering trust and adherence across the market.