Three-dimensional (3D) printing is thriving in the medical and scientific field and could ultimately have a huge impact in the medical practices of tomorrow.
Indeed, once generalized, this technique – which allows the creation of objects in volume by addition of materials – could allow healthcare facilities equipped with a 3D printer to manufacture medical devices (MD) adjusted to the physical specificities of each patient.
Thus, 3D printing could promote the local – and even artisanal – manufacturing of “custom-made” medical devices, which could raise issues about quality and the safety of patients.
However, the new European Regulation related to medical devices – as adopted by the European Union (EU) Council on 5 April 2017 (“Regulation”) – does not directly include this innovation.
One may therefore question the legal framework applicable to those medical devices and the potential consequences for the industry which manufactures mass-produced devices capable of meeting the same therapeutic needs.
To address these questions, one may consider this type of devices as “custom-made devices” whose regulatory framework is less constraining than the one related to general regulation of MD (I). However, the manufacturing procedures for this type of MD may also lead us to consider other remedies such as “in-house” MD (II). In any case, the healthcare facility will have to comply with regulatory obligations related to its new status of “manufacturer” (III).
Could 3D printed devices be considered as a “custom-made” devices whose placement on the market is facilitated?
A custom-made MD is defined as a device that (i) is prescribed by a qualified healthcare professional – whose written prescription should include specific design characteristics of the MD – and (ii) is intended to be used by only one patient to meet its proper medical needs (Article 2 of the Regulation).
There is therefore no doubt that the manufacture of 3D printed MD (i) according to the anatomical characteristics of a patient, (ii) in order to meet his/her proper needs, would likely to be qualified as “custom-made” device.
Such status benefits from a legal framework whose placement on the market is less constrained than that related to the general regulation of MD.
Indeed, manufacturers of custom-made devices shall only be bound by an obligation of conformity assessment procedures upon which the device shall be compliant with safety and performance requirements (Articles 10, 20 and 21 of the Regulation).
Therefore, these MD are not required to affix CE marking: a significant and constraining procedure demonstrating the safety and the performance of the device for the patient.
In this context, we can wonder if healthcare facilities – which would manufacture custom-made devices using 3D printing – could be real competitors on the MD market in comparison with industrial firms that must comply with CE marking procedures.
This risk appears to be limited. Indeed, the European legislator intended to give a narrow definition of the status of “custom-made” MD by providing that: “mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorized person shall not be considered to be custom-made devices” (Article 2 of the Regulation).
Consequently, mass-producing is excluded from the qualification of custom-made MD, even though the device requires adaptation to the requirements of the professional user.
A healthcare facility which intends to develop the manufacture of 3D printed MD would have to implement procedures which would lead to standardization. Such automation could lead health authorities and relevant jurisdictions to (i) qualify this production as “mass-produced manufacturing”, and (ii) apply the general regulation of MD including CE marking procedures.
The manufacture of custom-made devices by healthcare facilities would only concern single cases in order to fulfill a particular and proper need to a patient and for which there is not necessarily a mass-produced MD marketed which meets the same therapeutic needs.
Cases in which healthcare facilities could compete with industrial firms are rare.
The risk of reclassification of custom-made devices could lead healthcare facilities to study other regulatory remedies, such as “in-house” MD.