The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued guidance on 3D printing of medical devices and components in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19).
Scope of the MHRA Guidance
The present guidance published by the MHRA describes in detail the requirements to be applied for the medicinal products manufactured using 3D printing technology (additive manufacturing). The authority states that this technology could be widely used in manufacturing medical devices, including custom-made medical devices designed to match the needs of the particular patient, and also for manufacturing some kinds of orthopedic implants.
According to the guidance, the regulating authority receives an increasing number of requests from manufacturers to use the aforementioned technology. Manufacturers want to increase the manufacturing capacity of their production sites in order to meet the increasing demand for vitally important medical devices and ensure their availability during the pandemic.
The MHRA indicates that the particular requirements to be applied will actually depend on the type of the medicinal product in question. It is important to mention that the scope of the MHRA guidance on 3D printing covers:
- Medical devices, regulated under the Medical Devices Directive/Regulations, and
- Personal protective equipment falling within the scope of the PPE Regulation 2016/425.
The final determination should be made by the manufacturer of the medicinal product depending on the intended purpose. Irrespectively of determination, all products shall hold a CE mark confirming the compliance with the applicable requirements.
3D Printing of Medical Devices
The MHRA guidance describes the requirements to be applied in the case of using 3D printing technology to manufacture medical devices and related components. The authority emphasizes the importance of using original parts and components when it is reasonably possible. In the case that 3D printing technology will be used, the manufactured medical device components should be produced in accordance with the appropriate specifications to ensure they would be suitable to be used with the medical devices they are intended to be used with.
The MHRA also indicates that due to the fact that the materials used for 3D printing are different from ones used in the traditional manufacturing process, the difference in properties of the materials used could create additional risk even in a case if the design of the device remains unchanged. The authority requires medical device manufacturers to implement all the steps necessary to mitigate risks associated with the use of other materials. In particular, the medical device manufacturing using 3D printing technology in the manufacturing process will have to provide evidence confirming that in spite of changes to the materials the final medical device still meets any and all applicable safety and performance requirements set forth in accordance with the type of the device. In the part of the aforementioned requirements, the MHRA refers to the Essential Requirements/General Safety and Performance Requirements described in the Annex of the Medical Device Directives/Regulations.
The MHRA guidance also covers the most important aspects related to 3D printing of medical devices and components including, inter alia, the following ones:
- Technical requirements. The particular technical requirements the medical device should comply with depends on the intended purpose of the device as defined by the medical device manufacturer. In general, the medical device manufactured with the help of 3D printing technologies shall meet the same requirements as the device of the same kind manufactured using conventional methods.
- Biological safety. According to the MHRA guidance, the medical device manufacturers shall provide evidence confirming that the materials used in the 3D printing process meet applicable safety requirements. Due to the specifics of the technology, the manufacturer shall also describe the way the process itself impacts the materials and their properties. In the part of biological safety, the device should also meet the requirements set forth by the international harmonizes standards, such as ISO 10993.
- Sterilization and decontamination. It is also necessary to provide sufficient evidence demonstrating the medical device in question will pass all necessary sterilization procedures. For this purpose, the medical device manufacturer may also make references to the applicable international harmonized standards (e.g. BS EN ISO 17644 and BS EN ISO 556).
3D Printing of Personal Protective Equipment
Another part of the MHRA guidance is dedicated to the requirements applicable to the personal protective equipment manufactured using 3D printing technology providing that such equipment is intended to be used during the pandemic.
The authority acknowledges that 3D printing is being widely used to manufacture certain components to personal protective equipment. As in the case with medical devices, the particular regulatory requirements to be applied will depend on the intended purpose of the product in question determined by its manufacturer.
The MHRA describes the way the applicable requirements should be determined by providing the example with the face mask – one of the products that become vitally important in the context of the COVID-19 outbreak. In particular, the authority states the following:
- The surgical (medical) face mask intended to protect patients in the course of various procedures shall be determined as a medical device, and thus regulated under the Medical Devices Directive/Regulations.
- At the same time, the face mask intended to protect the person wearing it actually falls under the definition of the personal protective equipment and should comply with the PPE Regulation 2016/425 accordingly.
- However, in a case, if the product in question has a dual purpose, it should be regulated as a medical device, while the requirements for personal protective equipment should still be applicable.
Exceptional Use Authorization for PPE and Medical Devices
In accordance with the MHRA guidance on 3D printing of medical devices and personal protective equipment, the aforementioned products could be allowed to be marketed and used in the UK under the exceptional use authorization – a special framework introduced by the authority to expand and ensure the availability of vitally important medicinal products during the pandemic.
In order to be able to place its medical device or PPE on the UK market, the manufacturer shall submit the appropriate application containing the following information:
- The indication of whether the product in question should be used to protect the patient, the person using the product, or both.
- The indication of the role of the applicant (e.g. a manufacturer or its authorized representative).
- Detailed information about the product subject to review.
- Justification of importance in the context of COVID-19.
- Explanations regarding the absence of a CE-mark.
- Confirmation of compliance with the applicable standards.
- ISO 13485 certificate confirmation.
- Information about the approval granted in another jurisdiction.
- Information about alternative products already available in the UK.
- The particular number of medical devices / PPE to be supplied.
- The estimated time necessary to pass a CE certification.
Summarizing the information provided hereabove, the MHRA guidance on 3D printing of medical devices and personal protective equipment (PPE) describes the requirements the products falling within the scope of the guidance should meet in order to be approved for marketing and use in the UK.
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