In the European Union, the manufacture of machinery and equipment generates a turnover of approximately 700 billion euros and an estimated production value of 600 billion euros annually. The European machinery sector is an attractive market also for non-EU businesses. To sell in the European Union, EU and non-EU manufacturers of machinery equipment must comply with the Machinery Directive.
Scope of the Machinery Directive
The Machinery Directive specifies safety and health requirements necessary to affix the CE marking and place products on the EU market. Machinery means an assembly of components, at least one of which moves, joined together for a specific application. Specifically, the drive system moving the machinery is powered by energy other than human or animal effort. Among other products, this legislation also covers safety components, lifting accessories, chains, ropes and webbing for lifting purposes as well as removable mechanical transmission devices.
Conformity assessment routes
Manufacturers of machinery equipment need to assess whether their product requires a third-party conformity evaluation by a notified body or not:
- Products listed under Annex IV of the Directive require the involvement of a notified body if they do not partly or fully conform to a European Harmonised Standard (EHS) or in case of absence of EHS. Annex IV includes 23 product categories. Some examples are circular saws, hand-fed surface planing machinery for woodworking, portable chainsaws for woodworking, vehicle servicing lifts, roll-over protective structures (ROPS), and falling-object protective structures (FOPS).
- For products not listed under Annex IV that conform to European Harmonised Standards covering all of the relevant health and safety requirements, manufacturers carry out internal checks on the conformity of the product.
In both cases, the manufacturer has to draw up and sign a Declaration of Conformity, compile a technical file in accordance with Annex VII, prepare instructions for use and affix the CE marking. However, it is important to note that there is a separate set of rules for partly completed machinery.
New legislation coming: Machinery Regulation
In December 2022, the Commission welcomed the European Parliament and EU Council’s agreement on a new Machinery Regulation. The Proposal, published in April 2021, foresees increased safety, more effective market surveillance, and adaptation to new risks and technologies. In the legislative process, the next step will be the formal adoption by the European Parliament and Council, followed by the Regulation’s publication in the Official Journal of the EU.
Just like the current Directive, also the new Machinery Regulation will fall under the scope of the Market Surveillance Regulation. Among others, this means that non-EU manufacturers must have an economic operator based in the EU, such as an authorised representative.
Our dedicated Library include all relevant Machinery Directive documents.
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European Commission. (2006). Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC. Retrieved in 12/04/2023.
European Commission. (2022). Commission welcomes political agreement on new rules to ensure the safety of machinery and robots. Retrieved on 12/04/2023.