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.
1. Description of the regulatory challenge
3D-printers used for decentralized manufacturing of products can bring along challenges for regulators. 3D-printers are run by software. But the software does not tell the 3D-printers what to print. To really print something, the 3D-printers need a data-set. The data-set instructs the 3D-printers what to print / where to print. It is not software, but pure data indicating at which point in the three dimensions there shall be substance and where not. The data-set can be accompanied by further instructions, e.g. on the material(s) to be used and how the device is to be printed. The data-set together with the further instructions will be referred to as “instructions” hereunder.
To understand the phenomenon of 3D-printers used for decentralized manufacturing of products, one has to look first at the different persons involved:
– There are first those natural or legal persons who develop the product and accordingly define the instructions, and therein namely the data-set instructing the 3D-printers what to print. We call this person here the “designer”.
– Second there is the person who has acquired the data-set in a view of obtaining a device. We call this person “client”.
– Third there is a person owning a 3D-printer, hereafter called the “owner of the printer”. This person can be the owner of a print-shop, thus a service provider / economic operator. However, it might also be the client himself or a friend or family member of the client. In the latter case, the owner of the printer is a private person.
The problem for regulators linked to 3D-printers used for decentralized manufacturing derives from the fact that none of the three persons involved is necessarily a manufacturer or producer in the meaning of applicable product regulation. The designer only develops and disseminates instructions, not devices/products. The client is not an economic operator who makes available devices to anybody, but a consumer or other user of devices/products. The owner of the printer is not necessarily an economic operator, but even if s/he is, her/his role is rather the one of a service provider, not the one of a manufacturer or producer in the meaning of regulation.
As a consequence, the obligations incumbent to “manufacturers” or “producers” in the meaning of the respective regulation cannot be attached to any natural or legal person. One of the cornerstones of product legislation is falling apart.
The second cornerstone, the process of manufacturing or producing, is also somehow diluted because it is split into two: the design development and the physical production.
As these cornerstones fall apart, regulated products can reach consumers or other users in high numbers without undergoing any conformity assessment procedure. The regulatory requirements are circumvented as there is a regulatory gap for this type of manufacturing. Regulators only set-up legal requirements when there is a real risk. Accordingly, there might be a risk for consumers or other users when the product falls into a regulatory gap. Whether it is worthwhile closing this regulatory gap has to be assessed for each jurisdiction, product type and risk involved on a case-by-case basis.
2. How to address the regulatory challenge?
It is possible to close the regulatory gap by setting-up specific obligations:
2.1 Obligations for the designer
The first target of regulatory measures should be the designer because he is responsible for the emergence of the product at many different places later-on. Designers could be obliged, by a sector specific provision or by a new regulatory act applicable on all kinds of regulated products:
– To undergo for their instructions the same conformity assessment procedure that manufacturers/producers have to undergo for their products. If this conformity assessment procedure implies the testing of a physical device or other product, they must present a product printed in accordance with the instructions to the authority or to the private conformity assessment body;
– To undergo a conformity assessment procedure for the risks specifically linked to the decentralized manufacturing by 3D-printing and by lay-persons. This specific conformity assessment procedure should e.g. verify that the materials recommended for 3D-printing are appropriate in a view of the design and the intended use and that the 3D-printing with these materials does not trigger specific health risks, e.g. by evaporation. All the printing and assembly instructions should be clear. It should not be reasonably foreseeable that the lay-persons make mistakes when 3D-printing or assembling the product from 3D-printed products. Thus this conformity assessment procedure could cover both device specific and manufacturing specific aspects;
– To ensure that the products may only be printed by licensed qualified 3D-printshops (in case that the printing and assembling by lay-persons triggers high risks).
The enforcement of the obligations is of course extremely difficult when the designer is not based on the territory of the respective jurisdictions. However, the emergence of Internet business will make cooperation between jurisdictions ever more important – and why not foreseeing mutual assistance of jurisdictions for this case as well? Furthermore, more and more jurisdictions will, over time, develop national firewalls to counter illegal activity like terrorism. Once there are such national firewalls, enforcement via blocking of illicit websites become possible. Finally, jurisdictions can foresee obligations of Internet operators to block certain content.
But even when the designer is based in the territory of the respective jurisdictions, it will not always be easy to ensure enforcement. It might be helpful to consider measures of alternative / participative enforcement by private persons presented by the Handbook “How to regulate?” on this website.
2.2 Obligations for the owner of the 3D-printers
The owner of the 3D-printers could be obliged:
– To print only regulated products if the printing instructions have undergone the respective conformity assessment procedure;
– To undergo specific training in case of use of high-risk materials or printing of high-risk products;
2.3 Obligations for the manufacturers of 3D-printers
The manufacturers of 3D-printers could be obliged to affix, on their 3D-printers, a warning that 3D-printing of certain products might be sanctioned or subject to legal conditions, together with a link to a website of the respective jurisdiction informing about:
– Which products may not be 3D-printed because they are subject to a specific distribution license (e.g. certain arms);
– Which products may only be printed when a certain conformity assessment procedure has been undergone (plus essentials on how to verify whether such a procedure has been undergone successfully);
– Essentials on design protection law so that 3D-printing does not become a booster of counterfeiting;
– Sanctions and liability provisions;
– Risks of 3D-printing;
– A contact address for whistle-blowers who wish to inform about infringements.
2.4 Obligations for the clients
In extreme cases, e.g. for high-risk-products, it might be worthwhile considering to establish obligations for the clients as well. Clients could be informed about these obligations by the warning visible on 3D-printers and the website mentioned above.
3. Special cases
3.1 The print-shops are owned by the designer
In this case, the manufacturing is still decentralized, but the whole business model is quite similar to the classic model of a manufacturer selling a product and having full responsibility of the product. Subject to the contractual arrangements and the product legislation of the respective jurisdiction, there is or there isn’t a regulatory gap in this case. However, even if there is no regulatory gap at first sight, jurisdictions might identify a need to regulate: the decentralized manufacturing might trigger particular risks even though the print-shops are owned by the designer.
3.2 Design developed in a peer-to-peer-process
So far we have assumed that there is one natural or legal person who is the designer. But what if there are many persons who have developed the design in an open peer-to-peer-process and make available the result under a creative commons or similar license? To cope with the phenomenon of peer-to-peer-developed design, the legislation should request, for all instructions made available, the nomination of a responsible natural or legal person taking over the obligations of the designer described above.
4. Applicability of the same principles to product kits and pure manufacturing instructions
Subject to the respective law, the delivery of product kits may or may not be covered by product legislation. If product kits do not fall under the respective product legislation, the responsibilities of “designers” as defined above should also be applicable to those natural or legal persons who provide for a kit. Otherwise these persons can circumvent product legislation by decomposing products into components and selling these components in a kit instead of selling finished products.
In some jurisdictions, there is a movement of citizens who wish to manufacture their products themselves. In these jurisdictions, there is a need and thus a market for manufacturing instructions. In case of very dangerous products (e.g. firework items containing explosives), it could be considered to establish requirements for the author of these manufacturing instructions.