3D printing is an exciting technology that is developing rapidly. While high performance industrial systems can cost between £10,000 and £700,000, home desktop printers are now costing much less, between £1,000 and £7,000. This opens up the possibility of home manufacturing for anyone who can afford a 3D printer. And, while we wait for home printers to become more sophisticated, the public has increasing access to “copy shops” providing 3D printing services. Equally, there are plenty of online offerings. These services are being used to print a huge array of 3D objects, including: gadgets (eg, phone cases); toys (eg, action figures, chess pieces, toy bricks); and frames for glasses. Spare parts for products can also be printed, and the prospect is raised of the technology being used to make relatively simple medical devices.
With any form of manufacturing, there will always be the possibility that third party intellectual property rights are infringed. The difference now is 3D printers make this so much easier by removing many of the overheads and logistical difficulties that go with traditional manufacturing processes, such as the need for a factory and transportation.
With this relatively new form of cheap and accessible manufacturing, come two key threats for rightsholders:
- The use of 3D printing on a large scale has the potential to allow counterfeiters to manufacture goods in their home market thereby avoiding customs seizures.
- The ability for the public to produce their own articles, without purchasing them direct from retailers, aided by file-sharing sites whereby the public can download the computer aided design (CAD) files necessary for a printer to create a particular object.
So, what can be done by those who have invested in the design and development of medical devices to prevent copying by 3D printing? 3D objects can be protected by a variety of intellectual property rights, including patents, copyrights, trade marks and design rights.
However, the advent of 3D printing also poses challenges for medical devices legislation. For example, if simple medical equipment such as syringes are manufactured using 3D printing and sold, how does the ultimate consumer have the assurance that the material used to print them has had suitable toxicity testing? It is a concern for established manufacturers as well as consumers because of the potential safety threat posed to their consumers and any association it might have with the genuine products.
European medical devices law is currently being redrafted with the aim of introducing a new Medical Devices Regulation. One particular driver for the new regulation is a need that has been perceived for greater scrutiny of the supply chain for medical devices in order to improve safety. With this in mind, the Regulation is currently drafted to introduce a number of measures by which the authenticity of a device can be safe-guarded. In particular:
- Improved traceability of devices in the supply chain in which each party in the supply chain of a medical device can identify who it is that supplied them and to whom they have supplied the device in turn.
- Manufacturers will be required to undertake a phased and risk-based introduction of Unique Device Identification(UDI).
- The requirement for manufacturers and authorised representatives to register themselves and the devices they put on the market in the Eudamed database.
If implemented successfully, these measures are intended to guard against medical devices of poor quality entering the supply chain. They have particular application to counterfeit products made with 3D printers because they provide customers and end users with the means to check that the goods are regulated at the point of purchase: if there is no source identified, no UDI or no registration, then consumers know to leave the product alone.
The European Parliament is due to vote on the draft Medical Devices Regulation this autumn. After this the proposal, together with its sister proposal for an IVD Regulation, passes to the European Council for agreement or further amendment.
The amendments and the progress of the legislation can be tracked here