3D printing and medical device regulation

Under the MDR the definition of custom-made devices has changed

3D printed medical devices are subject to the same regulatory processes as other medical devices which entail the same degree of risk.

Within the EU medical devices are regulated by ‘The EU Regulation on Medical Devices 2017/745’ (known as MDR) or ‘The EU Regulation on In Vitro Diagnostic Medical Devices 2017/746’ (known as IVDR). These regulations are being brought in over a transition period and by 2020 will have replaced European Council Directives 93/42/EEC (for medical devices, known as the MDD) and 90/385/EEC (for active medical devices), and by 2022 will have replaced 98/79/EC (for in vitro diagnostics), with both sets of regulations applicable over the transition period. These regulations classify devices by the risk inherent in their use, with medical devices classified as I (lowest risk, e.g. spectacles), IIa, IIb and III (highest risk, e.g. pacemaker). All medical devices require assessment to ensure that they are fit for purpose.

This ranges from self-assessment for low-risk devices to assessment by a notified body (an independent organization designated to carry out assessments) for high-risk devices, and assessment by a national competent authority (such as the MHRA in the UK) or expert panel for the highest risk devices. Mass produced devices which have been successfully assessed can be CE marked, and introduced to the market, in all cases with appropriate post-market surveillance.

The majority of 3D printed medical devices to date have been under MDD regulation and will in future fall under MDR regulation. In many cases, 3D printed devices are designed around the needs of a specific patient, and these are considered ‘custom-made’, defined as

specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person’s professional qualifications which gives, under that person’s responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.

Under MDD custom-made devices do not require a CE mark but require a prescription from an appropriately qualified registered medical practitioner and must meet the same essential requirements indicated by the regulations in terms of fitness for purpose. For each custom-made device, a statement must be recorded which defines and uniquely identifies the device, names the patient and outlines conformity with general safety and performance requirements. Post-market surveillance is required.

MDR changes the definition of custom-made devices, as under MDR ‘devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices’. Since 3D printers are industrial manufacturing processes, this means that as part of the assessment of custom-made devices manufacturers could (depending on how the phrase “mass-produced” is interpreted) have to define how and why devices are customized and to show that the safety and performance of devices is assured across the range of the potential customization. The precise interpretation will need to be tested as MDR comes into force. However, what is clear is that from 2020 custom-made devices will be regulated in the EU in a similar way to standardised devices. Where there is any doubt regarding the regulatory requirements, consultation with a notified body is recommended

The MDR regulation is similar to the situation in the US, where for most classes of device 510(k) accreditation from the FDA is required. The 510(k) submission for patient specific devices also must define the extents of customization, such that fitness for purpose across the range of the potential customization can be evaluated, and the FDA have issued detailed advice on the use of 3D printing techniques to make medical devices. For rare conditions the FDA allows up to five devices a year to be produced with ‘custom device exception’, meaning that these devices can be produced without a 510(k) submission, but subject to all other regulatory requirements.

This is an excerpt from the BSI medical devices white paper The impact and potential for 3D printing and bioprinting in the medical devices industry. To download our other medical device white papers, please visit the Insight page on the Compliance Navigator website.