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Medical Devices

Custom-made and other Personalized Medical Devices: International Regulatory Requirements

Thursday, May 7, 2026
16:45 - 17:45 WEST
Location: Pavilion 3
Learning Level: Intermediate
Description: The regulatory landscape for personalized implants—a technology that is making personalized medicine come true with technologies like patient matched and custom-made devices—is rapidly evolving.

As technologies like 3D printing make these unique devices more common, regulators globally are shifting away from broad "custom-made" exemptions toward stricter, more defined pathways.

This session is designed for regulatory professionals who need to master the critical differences between a Custom-Made Medical Device (CMMD) and a Patient-Matched Medical Device (PMMD), as defined by international bodies like the IMDRF.

By attending, you won't just learn definitions; you will gain a strategic, global perspective essential for your career. You will walk away with a clear understanding of the diverse requirements across key markets—including the US (FDA), Brazil (Anvisa), Australia (TGA), and Europe (MDR)—
allowing you to strategically plan market access and reduce costly, time-consuming errors.

Specifically, you will learn to interpret the nuanced regulatory requirements for design envelopes, worst-case testing, and unique labelling demands for patient-matched implants. This knowledge will enable you to guide your R&D and Quality teams effectively, ensuring your company remains compliant while harnessing the growth opportunities in this cutting-edge sector. We will also explore future trends, like point-of-care manufacturing and the push for international standards, ensuring your regulatory strategy is future-proof.

Learning Objectives:

  • Differentiate between a Custom-Made Medical Device (CMMD) and a Patient-Matched Medical Device (PMMD) based on established regulatory definitions and the concept of a "design envelope," ensuring the correct classification is applied for initial market access planning.
  • Compare the diverse and often conflicting regulatory pathways for personalized implants across key global jurisdictions (e.g., US FDA, Europe, Brazil, and Australia) to strategically formulate an efficient international submission plan.
  • Interpret and apply the critical submission requirements—specifically for design validation, worst-case testing rationale, and unique patient-specific labelling—to successfully prepare a compliant Patient-Matched Medical Device dossier.