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MACHINE BUILDING
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. I have listed below 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 is important to note that anyone who makes a “substantial modification” to a piece of 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.
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AUTHORISED REPRESENTATIVE 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
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.
Whilst storing or transporting machinery, importers 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. 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, they must also maintain a register of complaints and keep distributors informed. They may also be required to take corrective actions to recall non-conforming products from the market and inform local authorities and the manufacturer. Machinery must also be marked with their importer details. 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.
DISTRIBUTOR
Distributors must act with due care in relation to Regulation requirements, and verify that certain requirements, including CE marking, DofC, instructions for safe use, and safety information are available digitally or where required also supplied in hard copy.
Whilst 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.
While the Regulation has entered into force throughout all EU Member States, it does have a transition period of approximate 2.5 years, after which its application becomes mandatory. 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.
TÜV SÜD
www.tuvsud.com/uk
Summer 2024 UKManufacturing
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