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.
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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.
New survey results suggest there could be a drop of about 40% in the number of EU notified bodies testing medical devices. A rough calculation points to an even bigger potential drop in the number that will be ready in time, when the Medical Device Regulation fully applies in 2020. A close look at newly available data signals the prospect for a serious bottleneck.
MDR/IVDR Survey: Most Manufacturers Ready To Yank Some Legacy Products From EU Market; Hiring Up At Firms
The impending implementation of the EU's new Medical Device and IVD Regulations will cause most firms to pull select legacy devices and in vitro diagnostics from the EU market, a survey of 169 quality and/or regulatory professionals finds. The survey also revealed that companies are in hiring mode as the compliance dates for both regulations approach. Quality and regulatory officials from Abbott Laboratories and Meridian Bioscience weigh in.