The FH Münster team say that the number of papers making reference to 3D printing or rapid prototyping is increasing dramatically. Image via FH Münster.
Yet more clinical AM ambiguity?
Published earlier this year, the MDCG’s Q&A has attempted to clarify that custom devices are those with “specific design characteristics,” which are incorporated to meet a particular patient’s “individual conditions and needs.” The document also introduces two new classes of personalized clinical products: ‘patient-matched medical devices’ and ‘adaptable medical devices.’
Critically, any medical implements that fall into these categories aren’t covered by MDR regulation, thus they won’t qualify for a simplified approval process, potentially making them much more difficult to bring to market.
What’s more, instead of defining its new class of custom devices itself, the MDCG’s Q&A refers back to a International Medical Device Regulators Forum (IMDRF) document issued in 2018. This clarification states that ‘adaptable devices’ will be considered as such if they need to be “adapted, adjusted, assembled or shaped at the point of care, in accordance with the manufacturer’s validated instructions.”
Despite the MDCG’s efforts to simplify matters, the FH Münster researchers say that they’ve actually made things more complicated, primarily due to the fact that the Q&A contradicts a previous ruling on the issue which stipulated that “devices which are mass-produced by means of industrial manufacturing in accordance with the written prescriptions… shall not be considered to be custom-made.”
The team has therefore pointed out that ‘patient-matched’ devices don’t require a prescription, thus the MDCG’s response has failed to clarify this element of MDR rules, or “conclusively, whether 3D printing is an industrial manufacturing process.”
As a result, the researchers’ paper concludes that EU regulation in this area falls far behind that issued by the US FDA in 2016, and in Australia, which has seen it adopt IMDRF recommendations. While the EU has shown signs of taking a similar stance, the scientists say that it remains too focused on ‘traditionally manufactured devices,’ and they now call for it to “adapt legislation to technical developments.”