The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
Additive manufacturing (also referred to as 3D printing) is well suited for the manufacture of a range of medical devices, such as in the production of patient specific models and some orthopaedic implants.
We have received an increased number of enquiries about the use of 3D printing to manufacture medical devices and personal protective equipment (PPE) during the coronavirus pandemic.
The current health crisis has prompted an unprecedented demand for certain medical devices, some of which may be 3D printed by exploiting the flexibility and ease of use of the technology.
Advice for those using 3D printing
The requirements manufacturers need to meet when 3D printing will depend on whether the item is a medical device, or a piece of personal protective equipment (PPE). This is determined by the manufacturer and primarily depends on the intended purpose for the individual product being manufactured. In general, products intended to protect the wearer will be PPE whilst those intended to protect a patient are likely to be medical devices.
Medical devices must meet the requirements detailed in the Medical Devices Directive/Regulations to hold a CE mark.
Whereas, personal protective equipment (PPE) must meet the requirements of the PPE Regulation 2016/425 to hold a CE mark.
Further information on the requirements for PPE products
More information on the process for medical devices can be found in how to conform with the legal requirements for placing medical devices on the market.
To ensure a continued supply of medical devices, we are considering exceptional use applications from manufacturers of medical devices where there is a significant clinical need during this pandemic.
Those using 3D printing to produce non-CE marked medical devices must consider the following before submitting an application for an exceptional use authorisation to us.
Working with existing parts and manufacturers
Manufacturers and professional users should try to use original parts or those with the same specifications, dimensions, and performance of the original parts, if available.
Those engaged in 3D printing should consider collaborating with the relevant medical device manufacturer, as important design specifications of interfacing components may be available to access.
Differences in material properties and processing requirements between 3D printing and conventional manufacturing methods mean that new risks may be introduced to patients or users, even when the same device design is being manufactured.
All medical devices are expected to be designed to reduce risk as far as possible. Manufacturers must be able to demonstrate how they have met the high levels of safety and performance expected from all medical devices. This includes conforming to the Essential Requirements/General Safety and Performance Requirements (Annex I) of the Medical Device Directives/Regulations.
A wide range of technical aspects need to be considered, tested and documented. The U.S. Food and Drug Administration (FDA) published useful general guidance on the technical considerations for additive manufactured devices.
Specific technical assessments need to be considered depending on the intended function of the device. For example, all parts contacting or containing pressurised gas, whether in the patient gas pathway or not, must meet the same relevant safety standards as devices manufactured using conventional methods, such as standards relevant to burst and leak resistance.
Manufacturers should be able to evidence the exact composition of the material being put into the 3D printer and understand precisely how the printing process and all chemicals used in this process affects that material during assembly and in the final product.
Comprehensive evaluation of relevant biological safety endpoints in compliance with relevant safety standards, such as the biological safety standards series ISO 10993, is essential.
Any vapours, wear debris, degradation products and processing residues that may be released from the 3D printed part must be demonstrated to be to non-toxic to a high level of assurance.
Sterilisation and decontamination
The medical device manufacturer should have objective evidence available that validation of the processing procedures has been undertaken to confirm that the specific medical device will be clean, disinfected and/or sterilised when processed as directed.
- shelf life
The manufacturer should demonstrate with scientific evidence, acceptable residual levels, following each of the processing stages in compliance with harmonised standards, such as BS EN ISO 17664 and BS EN ISO 556.
Personal protective equipment (PPE)
During the coronavirus pandemic, 3D printing has been used primarily in the production of headbands for face shields, visors and other items of protective equipment. The regulatory requirements for these products are different depending on their purpose.
For example, surgical (medical) face masks are intended for use by health care staff to protect patients during surgical procedures and other medical settings. These products are regulated as medical devices rather than PPE and must meet the requirements detailed in the Medical Devices Directive/Regulations.
Face masks that are intended to solely protect the wearer are regulated as PPE. Personal protective equipment must meet the requirements of the PPE Regulation 2016/425.
For products with a dual purpose, for example the item is intended to be used to protect both the patient and the healthcare worker, any MHRA exceptional use authorisation granted would only cover regulatory aspects associated with the Medical Devices Directive/Regulations. These products will still need to meet the relevant essential health and safety requirements of the PPE Regulation 2016/425.
More information on the distinction between medical devices and PPE can be found in the MHRA guidance on the regulatory status of equipment during coronavirus.
Information on producing PPE can be found in the guidance for new small-scale manufacturers of COVID-19 PPE issued by the Office for Product Safety and Standards.
Further information on the technical specifications for PPE and guidance on infection prevention and control for COVID-19 is also available.