The International Medical Device Regulators Forum (IMDRF) says personalized medical devices (PMD) come in three varieties that require different regulatory approaches. As certain technologies have become cheaper and more ubiquitous, harmonizing regulatory oversight of PMDs may speed accessibility across jurisdictions and address the question of who takes responsibility for their safety and efficacy.
IMDRF published a guidance on 14 September 2023 on PMDs that aims to harmonize how different regulatory bodies oversee such devices and provides considerations when they may need to be addressed differently depending on the regulatory agency. While the Global Harmonization Task Force (GHTF) has produced documents on the topic in the past, IMDRF argued that technology has evolved, and those documents may be outdated now…
