Step up a gear

THE EU Machinery Regulation (EU) 2023/1230 was published in the EU Official Journal on 29 June 2023 and will replace the current Machinery Directive (Directive 2006/42/EC). The new Regulation introduces more concrete machinery safety provisions that are a legal requirement for machinery manufacturers and other economic operators. This gives machinery end-users more legal certainty by defining binding requirements imposed on the design, construction and placing into operation of machinery and related products. 

The UK government has announced that CE marking for machinery will be extended indefinitely beyond 2024. This means that from 20 January 2027 CE marked products in the UK will also need to comply with the EU Regulations. At the point of writing this article, no announcement has been made if UK regulations will be updated to align UKCA requirements with the EU, but it can be assumed that any UKNI+CE marking must align to the new EU Machinery Regulation.  

Chapter 1 – General Provisions (Articles 1 – 9)

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 products. It also includes ‘high risk’ categories of machinery and related products listed in Annex I which may be subject to conformity assessment procedures involving a Notified Body, safety components, and the essential health and safety requirements (EHSRs). 

The main changes within Chapter 1, which have practical implications compared to the 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, The AI-act, etc.

Conformity assessment procedures

This new Annex I is essentially the old Machinery Directive Annex IV. However, it has been segregated into parts A and B. A good way to think of this is that while machine groups within Annex I are classed as ‘high risk’ machinery, those within Annex I 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 I.A, with this section containing a total of six machine groups, which are:

1. Removable mechanical transmission devices including their guards.
2. Guards for removable mechanical transmission devices.
3. Vehicle servicing lifts.
4. Portable cartridge-operated fixing and other impact machinery.

And the two new groups of machinery being:

5. Safety components with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions. 
6. 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 Machinery Regulation has mandated that all machinery listed within Annex I.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 hindered. So, don’t wait too long before applying to a Notified Body for third-party conformity assessment and please consider the likely increase on their demand might reduce their availability. 

High risk machinery groups within Annex I.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 which are specific the 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 now includes conformity assessment by 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’ as it requires module C and Unit Verification for ‘one-off’ builds. 

Scope expansion

The scope of the Machinery Regulation has also been expanded to encompass the entire supply chain with specific obligations for all market participants. Chapter two of the Machinery 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. I have listed below some of the main aspects to be aware of.

Manufacturer

Technical Documentation and an EU Declaration of Conformity (DoC) 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 must now also contain a digital contact detail, such as website or/and email. It must 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 DoC. For machines where it is foreseeable that non-professionals will be the user, then a hard copy DoC and instructions must also be provided.

For partly completed machinery the same requirements remain, but access to the Declaration of Incorporation (DoI) is provided digitally instead of the DoC. 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 term “substantial modification” which is a much welcomed and needed addition to remove ambiguity.

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 DoC/DofI for a minimum of 10 years after placing the machinery onto the market. They must interact and co-operate with local authorities on request.

Importer

‘Importer’ means any natural or legal person established within the EU who places a product within the scope of the Machinery Regulation from a third country on the market, and they must place only compliant machinery on the market. Whilst 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 or have them 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 the manufacturer and 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 DoCs for 10 years. Where deemed appropriate, they are required to perform, or have carried out, sample testing of products to ensure conformity is being achieved by the manufacturer through ongoing production control. Where necessary, they must maintain a register of complaints and keep distributors informed. They may be required to take corrective actions to recall non-conforming products from the market and inform local authorities and the manufacturer. They will 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.

Something that must be noted here is that an end-user of a machine could also be the importer of the machine. For example, if 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.

Distributor 

‘Distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market within the scope of this Regulation. Distributors shall act with due care in relation to the Regulation’s requirements and verify that certain requirements, such as CE marking, DoC, instructions for safe use, and safety information are available digitally, or where required supplied in hard copy with the machinery.

Whilst storing or transporting the machinery, distributors must 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.

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. 

Darren Hugheston-Roberts is a senior manager at TÜV SÜD. For more information, visit www.tuvsud.com