Personalized Medical Devices (PMD)
Advances in materials science, computational power, imaging and manufacturing technologies have made it possible to produce medical devices that are designed to meet the specific needs of a particular individual (i.e. personalized medical devices or PMDs). The manufacturing processes for PMDs is also shifting closer to the point-of-care (such as 3D printing in hospitals), which brings numerous advantages to patients and healthcare professionals. However, new risks have also emerged with PMDs and point-of-care manufacturing, which did not exist for traditional mass-produced medical devices.
The purpose of this Work Item is to develop guidance documents for providing harmonized recommendations for the regulation of PMDs. The adoption of consistent and harmonized requirements for PMDs across various jurisdictions will offer significant benefits to users, patients, manufacturers, and regulatory authorities.
The Working Group is currently developing an IMDRF Technical Document which will provide recommendations for production validation of PMDs. The document will provide technical guidance on:
- Validation of the specified design envelope that is one of the defining features of a patient-matched medical device
- Validation of a Medical Device Production System (a relatively new framework for regulating point-of-care manufacture of PMDs introduced in the IMDRF/PMD WG/N58 FINAL:2020)