EU MDR/IVDR and Their Impact on the Medical Device Industry
The EU MDR and IVDR frameworks bring much needed updates to decades-old guidelines in medical device manufacture. They affect organizations within the EU as well as those marketing into the EU from abroad and create potential challenges for the operations of those manufacturers.
Manufacturers have been preparing for these regulations in anticipation of higher costs and longer timeframes for developing new products. They have also been looking beyond these regulations to develop strategies that will allow them to thrive in a new and rapidly changing regulatory environment.
This report investigates their readiness for these regulations, particularly how they have respond to disruption caused by COVID-19, and probes how manufacturers are responding to new compliance challenges.
Download the report to read insights directly from members of the medical device and in-vitro diagnostics industry. Find out how organizations expect to be impacted by these new regulations and what they can do to move forward.