[FEATURED] Commission’s Draft EU Standardization Request May Overwhelm Tech Committees At 11th Hour
A great many EU medtech standards may not be ready in time for manufacturers to demonstrate compliance with the new regulations when they apply in 2020 and 2022. So, what […]
[FEATURED] EU Regulatory Reads, June 2018: Experts Tell Industry To Get Moving Despite Shortfalls – Shift Later!
Pressure is building on companies to start compliance efforts to the EU Medical Device Regulation. But a good deal of naivety remains in industry, and those who delay may lose […]
[FEATURED] New Reasons Not To Use EU MDR’s Four-Year Extension, But Comply Earlier Or Retire Products Instead
The new EU Medical Device Regulation offers companies an option to market CE-marked devices for an extra four years under current directives. But more hurdles are being identified that make […]