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New EU medical device regulations pose many compliance challenges

Jaclyn Jaeger | August 14, 2017

New regulations in the European Union aimed at modernizing the regulatory framework for medical devices are imposing several new compliance obligations on all medical device makers that want to market and sell their products in the EU.

The EU in May finalized and published two new regulations that fundamentally change and strengthen EU law on medical devices and in vitro diagnostic medical devices. Medical device makers now have until 2020, and in vitro diagnostic medical device makers have until 2022, to come into compliance with the requirements.

The Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR) replace three former directives on medical devices, last updated in the 1990s. Since adoption of the old directives, new methods and... To get the full story, subscribe now.