3D-printing of products in decentralized manufacturing constitutes a regulatory challenge. Normal product legislation will mostly not cover it. Thus there is a regulatory gap. Subject to the risks of the products and their manufacturing, it is worthwhile closing this gap.
If need there is, the gap can be closed by creating specific obligations for the designers of the product, for the owners of print-shops, the manufacturers of 3D-printers and sometimes even for the clients. The regulatory approach presented here can be adapted to atypical cases. It can also be used to cope with:
– devices sold as kits, and
– the marketing of manufacturing instructions for dangerous devices.