When the European Union's (EU's) Medical Device Regulation (MDR) was first introduced in 2017, it set in motion a three-year countdown to its full application in 2020. The MDR could drastically impact the way medical devices are made in the EU, particularly those produced using additive manufacturing (AM).
The new regulation suggests any medical device mass produced by means of an industrial process no longer falls under the "custom-made" exemption and therefore requires its own clinical evidence to authorize its sustainability. It also needs its own CE mark to prove it has been tested and meets all relevant standards.
The problem is there isn't a clear definition of "mass-produced" or "industrial manufacturing processes." Without these terms being defined, there is a risk the regulations will cover additively manufactured patient specific implants (PSIs) when produced on an industrial scale, even though each one is unique.
Additive manufacturing for healthcare
Additive manufacturing is a core technology for rapidly producing custom metal parts, with complex geometry for the medical sector. Metal powder is fused together layer by layer using a laser to build complex components that may not be possible with subtractive manufacturing.
Additive manufacturing can produce components with variable surface finish to suit different surgical procedures. It can also produce complex lattice structures more efficiently than traditional subtractive machining can.
The major advantage of the technology is it allows implants to be designed specifically to a patient's magnetic resonance imaging (MRI) or computed tomography (CT) scans. This means medical devices can be produced as a one off, unique product, specific to an individual's needs.
Patient-specific AM implants are helping to improve treatment processes, decrease procedure revision numbers and reduce surgery times, which can also reduce costs for the NHS and provide better patient outcomes.
Traditionally, if a patient had a particular cranial tumor, a surgeon would first have to remove the tumor and close the wound. The patient would then require further CT scans to determine the size of the cranial plate needed, dependent on the size of the wound from the previous surgery. The surgeon would then perform a second procedure to insert the implant.
Additive manufacturing removes the need for a second procedure by enabling pre-planning and the production of patient specific surgical tools, which define exactly the size of the wound left behind. Having fewer procedures needed for the same result improves the process for both patient and surgeon.
Despite the benefits AM has offered so far, the new MDR may interfere with the use of additive manufacturing in the medical industry in future. The MDR's subsequent guidance documents could be influenced if enough manufacturers have an input.
An interpretation of the regulation as it currently stands may mean AM will not be able to help patients in the same way once they come into full force. For the technology to reach its potential, industry and healthcare need to work together to develop a body of evidence to demonstrate the efficacy and benefits of the technology.
The only way to prevent the MDR from having a negative impact on AM is to prove its worth, not just for hospitals and medical professionals, but also for patients that have the potential to receive a better outcome.