Devices Without an Intended Medical Purpose under MDR 2017/745: A Guide for Manufacturers
INTRODUCTION Not a Medical Device… Until MDR Says You Are! (Hello Annex XVI) Devices without an intended medical purpose can still fall under EU MDR 2017/745 if they are listed in Annex XVI. The idea is simple: even if you’re not claiming “medical use,” these products can interact with the body in similar ways to […]
FDA Issues Draft Guidance on Menstrual Products: What Manufacturers Need to Know
United States, October 2025 — In a significant move aimed at enhancing safety and transparency in feminine hygiene products, the U.S. Food and Drug Administration (FDA) has released a draft guidance document titled “Menstrual Products – Performance Testing and Labeling Recommendations.” This guidance outlines key updates affecting manufacturers of tampons, pads, and menstrual cups, with […]