3-D Printing: Forgotten by the New EU Medical Device Regulation?

By Emmanuel Garnier, Pierre-Alexis Maingon
October 9, 2017


• Categories: 04-Product Design & Development, 05-Quality/Regulatory, Business Analysis

General context

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.

Attend the EU MDR Implementation Strategies Workshop | November 27–28, 2018 | Washington, D.C. or virtually | Learn MoreThus, 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.

Could “in-house” devices be a sustainable alternative for healthcare facilities?

Recital 30 of the new Regulation provides the possibility for healthcare facilities to “manufacture, modify and use devices in-house and thereby address, on a non-industrial scale, the specific needs of target patient groups which cannot be met at the appropriate level of performance by an equivalent device available on the market”.

The European legislator has provided the possibility for healthcare facilities to manufacture MD – called “in-house” devices – which are solely manufactured “in-house” in order to fulfill a therapeutic need of a group of patients.

Healthcare facilities could argue that, by using a printer only installed in their premises, the manufacture of a 3D MD meet a specific need of an identified group of patients, enabling the device to be considered as an “in-house” MD.

Such qualification would allow them to access to a less constraining framework of market authorization. Indeed, Article 5 of the new Regulation provides that, subject to the respect of mandatory declarations and simple documentation and “with the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices, manufactured and used only within health institutions established in the Union”.

If healthcare facilities pretend that 3D printed MD can be considered as “in-house” MD, they could benefit from a legal framework that would also be more favorable than the one for which industrial firms would have to comply with, whereas, in both cases the MD would meet the same therapeutic need. Such a qualification seems questionable.

The European legislator allows the manufacture and use of “in-house” device only in the absence of appropriate equivalent MD available on the market. Thus, there can be no competition between healthcare facilities manufacturing “in-house” device and industrial manufacturers.

In any case, if the regulatory framework related to custom-made devices and the one applicable to in-house devices appear to be more flexible, they are not exempt of any obligation. The healthcare facility will have to comply with the legal framework related to its new status of “manufacturer”.

Healthcare facility: a new entity which will be subject to the obligations related to the status of “manufacturer”

Any “natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark” is qualified as manufacturer (Article 2 of the Regulation).

Therefore, the legal or natural person that prints medical devices, including healthcare facilities, should be considered as such.

Healthcare facilities will be required to comply with obligations related to the status of “manufacturer” and will hold the same liability.

Concerning the manufacturing of custom-made MD, manufacturers will have to gather technical documentation set out in Annex XIII including in particular “the name of the person that established the prescription” and the “specific characteristics of the product” (Article 10 of the Regulation).

This documentation shall be made available to the relevant health authorities and updated on a regular basis. Therefore, manufacturers’ healthcare facilities must implement processes to update this documentation for each new patient, indicating especially the name of the prescriber and the specific characteristics of the custom-made MD that will be printed.

Similarly, concerning the manufacturing of “in-house” MD, manufacturers will have to comply with the general safety and performance requirements which involve in particular drawing up documentation and maintaining a quality management system (Article 5 and Annex I of the Regulation).

The regulatory status of “manufacturer” could imply significant administrative and regulatory constraints, particularly if the manufacture of MD involves the use of nanoparticles, which leads to compliance with the most stringent procedures regarding the conformity assessment procedures of the device (Recital 15 of the Regulation).

While the purpose of the new Regulation was to modernize the current legislation and – to quote Mr. Christopher Fearne, Chairman of the EU Council – to allow “more innovative and safer devices on the market” – we can only regret that the European legislator has not provided 3D printing with a specific legal status.

It will be interesting to follow the interpretation of the provisions of this new Regulation by the health authorities and the relevant jurisdictions, and more especially as it will necessarily have an impact on the market of medical devices and hospital practices.