The Effect of Medical Device Regulation on 3D Printed Specific Implants

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The medical regulation environment has always been a tumultuous sea.

Although regulations are necessary to guarantee protection and guidelines to both patients and doctors, the likelihood that any piece of regulation will be completely satisfactory to even one of the many stakeholders is nearly non-existent.

The Medical Device Regulation (MDR) is a good example of how regulation can affect specific groups of stakeholders.

Created in 2017, the regulations might highly affect manufacturers of patient-specific implants (PSI), a development in the practice of medicine that has been made possible because of the capabilities of 3D printing to create custom devices, but on an industrial scale.

The new regulations, in fact, remove the exemptions for custom made for any devices that are manufactured on an industrial scale and therefore require that they have their own clinical data to demonstrate their sustainability. This could greatly impede the production of PSI, despite the fact that they have repeatedly been demonstrated to have positive impacts on surgical outcomes.

The key in this controversial situation is to make sure that the great benefits provided through the customization capabilities of 3D printing will continue to grow.



Categories: Biomedical