Manufacturers are increasingly partnering with third-parties to utilize 3D printing techniques to produce replacement parts. This allows for the on-demand manufacture of spare parts for repairs, often at a lower cost point than is achievable using traditional manufacturing techniques. It also opens the door to the manufacture of parts by non-traditional manufacturers, including specialist 3D printing services, repair shops, and even end users. The advantages of 3D printing need to be balanced against the risks, including that spare parts 3D printed by third parties could be of insufficient quality. In this blog, we explore the product compliance, safety and liability implications, which are currently under scrutiny by product safety regulators around the world.

3D printing and spare parts manufacture

3D printing (or additive manufacturing) is a manufacturing process for creating three dimensional physical projects using digital files and specialized equipment to layer successive thin layers of materials e.g. polymer, ceramic or metal. It has several advantages for manufacturing spare parts in consumer products:

  • Allows for lower costs than the costs traditional manufacturing methods
  • Time savings in production and shipping
  • Potential for lower carbon footprint
  • Flexibility to print remotely and on-demand
  • Useful for older products, where spare parts are no longer stocked and a new manufacturing run may not be feasible

It also has challenges including:

  • Variable quality of materials, machines, operator expertise and end result
  • Limitations of the technology, meaning not all parts can be 3D printed
  • Concerns over sharing proprietary information regarding the design of some parts
  • Heightened risk profile around third party 3D printed spare parts compared to manufacturer’s own
  • Risk of unauthorized use of designs and manufacture of unapproved 3D printed spare parts

Safety and quality standards for 3D printed spare parts for Consumer Products

Currently, no legislation in the EU, UK or US is designed to regulate 3D printing specifically. This leaves the position regarding the safety and quality standards of 3D printed products a bit unclear.

Existing product safety regulations and general regulations for the supply of goods and services may apply depending on:

  1. what is being supplied;
  2. who is supplying the parts;
  3. whether the supply is B2B or B2C; and
  4. the activities undertaken along the supply chain.

Generally, manufacturers, importers and distributors have obligations under existing laws for the safety of products. Therefore, where a third party 3D prints spare parts and/or makes these available commercially, these parts will need to meet product compliance and safety standards, just like for other consumer products. In addition, existing consumer protection rules require repair services to carry out repairs using 3D-printed spare parts with reasonable care and skill. Failure to do so would be a breach of contract actionable by the consumer. However, the application of the law in this area is less clear when it comes to liability for defects in the component design file. This is due to the lack of express provisions covering whether digital content such as this is a product, good or service when not supplied in a physical medium.  More generally, there is also potential lack of clarity as to who would be considered to be the “manufacturer” of the 3D printed product in all circumstances, and therefore responsible for the obligations normally placed on a product manufacturer. The EU is currently considering software as a product as part of its review of whether the General Product Safety Directive remains fit for purpose in light of emerging technologies – with a draft legislative proposal expected in Q2 2021.

Unauthorised Spare Parts

3D printing is an area that is particularly at risk of counterfeit or unauthorised products which may pose safety or other (e.g. cybersecurity) risks. If manufacturers engage or allow third parties to 3D print parts, then they need to make design files available. These may be appropriated and used by rogue producers to manufacture unauthorized, inferior products which may pose safety risks. Where design files are not fully made available, the risk of unsafe products may be even higher as third parties will have to reverse engineer parts. Consumers affected by any safety issues with the counterfeit parts may struggle to hold the producers accountable. Supply of an unauthorised 3D printed part which has no inherent quality or safety defect and without the knowledge on the part of the supplier of its intended or foreseeable use, would not make the supplier in breach of applicable regulations. It would also not necessarily be liable for any negative consequences of the part being used for a product the part was not intended for.

Liability for 3D printed spare parts

Under existing product liability rules, producers of 3D printed parts will be liable for defects in the parts that cause damage. However, there may be difficulties establishing what caused the damage. For example, it may be challenging to establish whether the defect originated from issues with the design file, the materials used to manufacture it, the manufacture, storage or installation of the spare part, or the design or manufacture of the 3D printer. Moreover, there may be a greater number of different parties involved in the production and distribution process, so it may be challenging to identify, in a given case, who has caused the damage. This is likely to be further complicated where 3D printed parts are incorporated into a product and are not supplied by the producer or its authorized supplier. In those circumstances, it may be difficult to establish whether the part, or a latent defect in the product in which it was fitted, caused the damage.

More information

It is clear that we will see some regulatory intervention in this space internationally, and active discussions are ongoing at a policy level in many jurisdictions. Given the increasing importance of these technologies, we will continue to blog on developments on Productwise as they arise.

In the meantime, the UK’s Office for Product Safety and Standards (the “OPSS”) has considered some of the safety and legal issues relating to the manufacture, sale and installation of 3D printed spare parts made by unauthorised manufacturers for use in consumer appliances.  Its report, published at the end of last year, can be found here.

Posted by Edward Turtle