A comparative analysis of the US and EU performance-based regulatory pathways with recommendations for harmonisation

English

Regulatory frameworks for medical devices have historically balanced innovation with patient safety. Yet, as medical technologies become increasingly modular, software enabled and patient specific, traditional regulatory models face growing limitations. This article by Haroon Atchia critically compares the US Food and Drug Administration’s Safety and Performance Based Pathway (SPBP) and Article 18(3) of the European Union’s (EU) Medical Device Regulation. Although both regulatory mechanisms aim to reduce unnecessary burdens for mature technologies, they differ significantly in implementation, scope and operational clarity. Ultimately, the findings support an EU-specific adaptation of the SPBP principles, and the article proposes recommendations for harmonising and modernising the EU regulatory framework accordingly.

Specification: 8 pages plus covers, in English, supplied by email as a PDF.

This article has been published in the August 2025 issue of the Journal of Medical Device Regulation.