The new EU Machinery Regulation 2023/1230 supersedes the Machinery Directive 2026/42/EC on 20th January 2027 and there is no transition period. Preparation is key, so machine builders exporting to the EU must start updating their designs, procedures and paperwork to be ready in time.
Fortunately, most of the new Machinery Regulation (MR) is very similar to the old Machinery Directive (MD). Consequently, changes to machine designs or software are likely to be restricted to cybersecurity and artificial intelligence aspects.
In terms of paperwork, a number of revisions will be necessary, though these should not be onerous to implement.
One section of the MR is completely new, however, and this requires non-EU suppliers to have an economic operator (EO) established in the EU. Indeed, the obligations of EOs are given an entire chapter in the MR, running to several pages. EOs have important and clearly defined obligations, and the penalties for failing to act as required are severe. Without an EO, manufacturers are prohibited from placing products on the market in the EU.
In the context of the MR, an EO may be the manufacture, authorised representative, importer or distributor. If a manufacturer is not based in the EU and does not have a related company in the EU to act on its behalf, then the choice reduces to three options. Given that the manufacturer has to share detailed technical information and intellectual property with the EO, a machine builder might not wish to appoint an importer or distributor as its EO. Besides, importers and distributors might lack the technical competence to fulfil the role, and they may not wish to do so due to the responsibilities and potential penalties. This leaves an authorised representative (AR or EU AR) as the only viable option.
An AR can be a natural or legal person established within the EU, and the manufacturer must provide the AR with a written mandate stating that it can undertake specified tasks on behalf of the manufacturer.
The AR must be competent to understand the manufacturer’s conformity documentation and ensure that it is suitable for its purpose. If the market surveillance authorities enquire about conformity-related matters, the AR must be capable of responding on behalf of the manufacturer. ARs are also obliged to retain certain information for at least ten years after a machine has been supplied.
If the need for an EO or AR sounds familiar, it is because near-identical requirements have been in place for around five years under EU regulation 2019/1020 on market surveillance and compliance. By now, most machine builders exporting to the EU will have appointed an AR. However, some exporters might not have done so yet, and any machine builders who are considering exporting to the EU for the first time will need to appoint an EO (most likely an AR). Without an EO named on the paperwork, there could be lengthy and costly delays when a machine is held at the border. It may not be easy to find an AR willing to accept a mandate for a complex machine that is in packing cases in a customs warehouse.
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
