Why you need to update your machinery CE marking paperwork
In less than a year, the new EU Machinery Regulation 2023/1230 (MR) supersedes the Machinery Directive 2006/42/EC (MD) on 20th January 2027. Machine builders must be prepared, including manufacturers of series machines already in production. There is no transition period – the change will, in effect, be overnight. While some machine builders will only need to revise their paperwork, others may have to go much further.
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The new MR has additional essential health and safety requirements (EHSRs), such as those relating to cybersecurity. Any machine with a USB or network port will require an assessment. Machinery linked to networks or the internet, or that is capable of autonomous operation, will probably need assessing by competent IT professionals.
It is imperative that machine builders study the new MR and understand the implications. A new risk assessment might be needed for the whole machine or just certain aspects. Depending on the outcome, changes to the design, software or hardware could be required.
Annex I machinery (formerly Annex IV) built to harmonised standards will need a Notified Body Type Approval until the standards are updated and harmonised to the MR. It could be months or years until these are all harmonised.
Instructions
Instructions for use no longer have to be in ‘hard copy’, as the MR allows them to be provided digitally. However, a hard copy must be supplied free of charge if requested when the machine is ordered. Machine builders can potentially save money by not including a printed set of instructions with every machine but they need procedures for providing printed copies on request.
For partly completed machinery, the assembly instructions may be provided digitally, with customers able to request a free printed copy.
Declaration of Conformity
From 20th January 2027, the EU Declaration of Conformity (DoC) (previously an EC Declaration) must refer to the Machinery Regulation 2023/1230 instead of the Machinery Directive 2006/42/EC. A number of minor revisions must be made to the DoC; Annex V Part A of the MR states what the DoC must contain.
Previously, a machine might have been accompanied by more than one DoC for different Directives or Regulations. Under the new MR, a single DoC can list all of the laws with which conformity is being claimed.
For partly completed machinery, the changes to the DoI are similar to those for the DoC (Annex V Part B).
Many existing standards are not yet harmonised to the MR, so these should not be listed on Declarations.
Machine builders can now choose to provide an internet address or machine-readable code (eg QR code) from where the EU Declaration of Conformity can be accessed.
Quality assurance paperwork
The only revisions to quality assurance paperwork are likely to stem from changes necessary for complying with new EHSRs, such as those relating to cybersecurity.
Technical documentation
In the old MD, the term ‘technical file’ was used when referring to machinery, whereas ‘technical documentation’ was used for partly completed machinery. In the new MR, ‘technical documentation’ is used for both.
Unfortunately, some areas of the MR Annex IV (Technical documentation) are a little vague. For example, the MD requires the technical file to include a ‘general description’ of the machinery, while the MR requires a ‘complete description’ – and ‘complete’ is not defined.
Generally, the technical documentation needs more detail than previously.
Authorised representative mandate
Today, under EU regulation 2019/1020 on market surveillance and compliance, machine builders are required to have an economic operator established in the EU. The new MR requires the same.
Unless a UK machine builder has a related company based in the EU, it is likely that the only feasible way to name an economic operator is to appoint an EU Authorised Representative (EU AR). The machine builder must provide a mandate specifying tasks the EU AR is authorised to perform. If a mandate already exists for regulation 2019/1020, then it must be updated to refer to the MR as well.
Conclusion
Machine builders exporting to the EU must be ready for the new Machinery Regulation, even if the only changes are to paperwork. Non-compliant machines and paperwork could be held at the border.
Hold Tech Files Ltd is established in the Republic of Ireland and can act as an EU AR. Furthermore, its consultants can provide advice to help machine builders prepare for the new Machinery Regulation.
For more information, contact Hold Tech Files Ltd. www.holdtechfiles.eu
