The European Union’s (EU’s) 2017 Medical Device Regulation (MDR) set in motion a three-year countdown to full implementation. The MDR could drastically impact the way that medical devices are made in the EU, particularly those produced using additive manufacturing (AM).
The new regulation suggests that any medical device mass produced by an industrial process no longer falls under the custom-made exemption, requiring its own clinical evidence to authorize its sustainability, and its own CE mark to prove it has been tested and meets all relevant standards.
The problem is that there isn’t a clear definition of mass-produced or industrial manufacturing processes. Without these terms being defined, there is a risk that the regulations will cover additively manufactured, patient-specific implants (PSIs) when produced on an industrial scale, even though each one is unique.
AM for healthcare
AM is a core technology for rapidly producing custom metal parts with complex geometry for the medical sector. Metal powder fused together by a laser, layer by layer, builds complex components that may not be possible with subtractive manufacturing.
AM can produce components with variable surface finish to suit different surgical procedures and can produce complex lattice structures more efficiently than traditional subtractive machining processes.
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; medical devices can be produced as a one off, specific to an individual’s needs.
Benefits of AM
Patient-specific AM implants are helping improve treatment processes, decrease procedure revisions, and reduce surgery times, which can reduce health care costs and produce better patient outcomes.
Traditionally, if a patient had a cranial tumor, a surgeon would have to remove it, close the wound, and then the patient would require additional CT scans to determine the size of the cranial plate required. The surgeon would then perform a second procedure to insert the cranial plate implant.
AM eliminates a second procedure by enabling pre-planning and production of patient-specific surgical tools, defining the exact size of the wound and plate needed. Fewer procedures produce the same result, improving the process for the patient and surgeon.
Despite the benefits, the MDR may interfere with AM use in the medical industry in the future.
What can you do?
The MDR has been released, but subsequent guidance documents could be influenced if enough manufacturers have input. Patient-specific implants are already being used in surgeries around the world, with Renishaw working with hospitals in Wales and the South West in the United Kingdom (U.K.) to improve patient outcomes. (See sidebar)
An interpretation of the regulation as it currently stands may mean we will not be able to help patients in the same way. For the technology to reach its potential, industry and health care 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 who have potential to receive a better outcome.
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