The Machinery sector is an important part of the Engineering Industry. Machinery consists of an assembly of components, at least one of which moves, joined together for a specific application. The drive system of machinery is powered by energy other than human or animal effort.
The additive manufacturing (AM) sector helps mitigate several COVID-19 effects because it can quickly introduce additional industrial capacities to fabricate missing goods. The additive manufacturing process is also known as ‘3D printing’ (3DP) because it uses 3D printers to manufacture a wide range of products for different applications. 3D printed products themselves may also be used to produce medical devices. At the moment, there are examples of the use of 3D printing machinery tools to fabricate constituents of lung ventilators for Intensive Care Units. To help industry and small and medium enterprises (SMEs) explore the industrial capacities offered by additive manufacturing processes, we summarised frequently asked questions.
One of the main legislations governing the harmonisation of essential health and safety requirements for machinery at EU level is the Machinery Directive 2006/42/EC
The directive
As it is a 'new approach' directive, it promotes harmonisation through a combination of mandatory health and safety requirements and voluntary harmonised standards. The machinery directive only applies to products that are to be placed on the EU market for the first time.
The machinery directive 2006/42/EC was published on 9 June 2006 and became applicable on 29 December 2009. It was amended by Directive 2009/127/EC of the European Parliament and of the Council of 21 October 2009, with regard to machinery for pesticide application, and by Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market surveillance of agricultural and forestry vehicles, among others. Read the consolidated text of the directive.
This document provides guidance on the application of the essential health and safety requirements relating to ergonomics in section 1.1.6 of annex I to the machinery directive and the corresponding harmonised standards.
The Machinery Directive is the core European legislation regulating products of the mechanical engineering industries. The staff working document, SWD(2018)160, details the conclusion of the Machinery Directive's performance evaluation.
The evaluation shows that the directive is relatively flexible to technological developments in the digital era, thanks to its 'new approach' underpinnings. Furthermore, it is generally relevant, effective, efficient, coherent and has EU added value.
However, some of its provisions require better legal clarity and improved coherence with other legislation. Several administrative requirements that affect the Directive's efficiency could also use simplification. Finally, the evaluation indicates that the directive's effectiveness has been affected by shortcomings in monitoring and enforcement. The revision process is currently ongoing.
Nederlands Normalisatie-Instituut (NEN)
Vlinderweg 6
2623 AX Delft (The Netherlands)
Mr Okke-Jaap Prent
Tel.: +31 15 2690 156
e-mail: Okke-Jaap.Prent@nen.nl
The following 'recommendation for use' sheets reflect the common position of the notified bodies in the machinery sector. They have been endorsed by the machinery working group. Their purpose is to assist notified bodies in their tasks of conformity assessment of machinery, mainly for the EC type-examination procedure, in accordance with the terms of the machinery directive. All stakeholders involved in the implementation of the directive should be aware of the existence of this information
