The Cost And Complexity Of Implementing The EU Medical Device And IVD Regulations
Three experts talk about what it takes logistically for medtech businesses to prepare for timely compliance with the new EU Medical Device and IVD Regulations, and they spell out some of the challenges companies have encountered during a panel discussion at the recent LSX World Congress in London.
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One-Third Of SMEs To Change Notified Body; Half Believe EU MDR Deadline Extension Likely, Survey Finds
If the findings of a Swiss survey of smaller companies represent the picture around the EU in general, companies are ill-prepared for the new Medical Device Regulation, confused, and far from convinced of its value.
With just over 100 days to go until the full application of the EU Medical Device Regulation, notified body designations are trickling through. Ireland is the latest EU member state to have a resident MDR notified body.
In this second article of a two-part series, Eithne Lee of ISO Life Sciences global consultancy identifies some of the problems that medtech premarket innovators and SMEs are facing, with the EU MDR application date now less than four months away.