Ensuring Safety and Quality of 3D-Printed Medical Devices: 4 Points to Consider
3D-printing devices and 3D-printed medical devices significantly impact healthcare and improve patients’ lives worldwide. However, do you know how the safety of such devices is evaluated? In this article, we provide you with 4 key aspects to consider.
Process Chain Qualification and Validation: ISO/STM 52920:2023:
Additive manufacturing processes, like 3D printing, are increasingly becoming highly valuable and highly used as a viable alternative to conventional manufacturing methods. 3D printing supplies the growing trend towards developing complex parts and customized products across a wide range of industries, including Medtech. Ensuring these instruments' adequacy, safety, and high quality requires qualified and validated manufacturing processes. ISO/ASTM 52920:2023 provides standardized guidance for establishing quality-assured 3D printing and additive manufacturing processes. The document sets forth essential measures to control and monitoring of additive system operations to ensure the reproducible quality of additively manufactured parts. It is worthwhile mentioning that these requirements are supplementary to the requirements established by a Quality Management System (ISO 13485, ISO 9001, and others).
“Custom-Made Medical Devices” Vs “Patient-Matched Medical Devices”:
3D printing is an Additive Manufacturing process, in which 3D objects are built from the iterative superposition of 2D layers. This technology has opened innumerable doors to developing and manufacturing medical devices tailored to particular patient requirements. While 3D-printed medical devices can be tailor-made, they are not defined as “Custom-Made Medical Devices” by default according to EU MDR and the FDA! Instead, 3D-printed medical devices are generally categorized as Patient-Matched Medical Devices, which shall be evaluated following the current EU and FDA regulations.
However, it is essential to mention that some 3D-printed medical devices could enter the category of Custom-Made Medical Devices. Therefore, this needs to be case-by-case. In order to be considered Custom-Made:
Extracted from Question #5 MDCG 2021-3 (https://health.ec.europa.eu/system/files/2021-03/mdcg_2021-3_en_0.pdf
Biological Safety Evaluation and Toxicological Risk Assessment of 3D-Printed Medical Devices:
Unlike traditionally manufactured devices, which are limited to discrete sizes, 3D-printed devices can be produced in a continuous range of shapes with pre-defined specifications. This unique characteristic necessitates careful considerations during the devices' evaluation and testing to ensure their safety and effectiveness.
The ISO 10993-1 standard is the gold standard to follow while conducting an assessment of the medical device's safety. This international standard is designed to safeguard humans from potential biological and toxicological risks associated with the use of medical devices. It provides a comprehensive framework for categorizing devices based on their contact with the body. The evaluation process involves the examination of existing relevant data from various sources, identifying gaps through risk analysis, and determining additional data sets necessary to assess the biological safety of the device.
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The Value of a Good Biological Evaluation Plan:
Whether 3D-printed or manufactured by other means, a well-executed biological evaluation plan is of paramount importance in the development and assessment of medical devices. It serves as a comprehensive roadmap, guiding the evaluation process to assess the safety and effectiveness of these devices. A robust evaluation plan provides regulatory compliance and instills confidence in healthcare professionals, patients, and regulatory bodies alike. For this purpose, it is crucial to count on experience study monitors, like registered toxicologists and certified service providers, who can:
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With our expertise, JAKSCH LIFESCIENCE CONSULTING GmbH supports manufacturers, researchers, and developers in navigating the complexities of regulatory guidelines. We implement our “Smart Planning” strategy to:
o??Selection of Representative samples + extraction conditions
o??Chemical characterization
o??Physical characterization
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o??Biological tests
We support you with the biological and toxicological evaluations of your 3D-printed medical devices to demonstrate their safety. Our team of experienced regulatory toxicologists is committed to looking beyond the horizon and always advises you to find tailored testing strategies and minimize potential risks.
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????Assess Biocompatibility of your Medical Device from Risk Management prism | MedTech Enthusiast | Chemist | Women in Tech Award Nominee
8 个月That is an interesting opinion that registered toxicologists can create a biological evaluation plan. From my experience, Biocomp SME is creating such a plan, analyzing materials, performing literature review and identifying the gaps and than based on risk benefit analysis pick the required tests. Certified toxicologist is invited when challenging materials are used and / or the results of E&L testing are not clear. What do you think on it?