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Answering Questions Surrounding Custom, Adaptable, and Patient-Matched Medical Devices

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Technological advancements in manufacturing make it possible for manufacturers to commercially produce personalized custom medical devices (CMD) much faster. The advancements, when coupled with regulatory changes, can be confusing. That’s why we’ve created this brief review to help clarify the most critical points within recent European Medical Device Regulation (MDR) updates. MDR Article 2(3) defines … Continued