Do What You Can, And Do It Now: MDR/IVDR Experts Advise Industry To Move Quickly
There are hurdles to compliance with the EU Medical Device and IVD Regulations – but companies must jump them now. A look at why it's time for manufacturers to throw themselves into MDR/IVDR compliance, even if they will sometimes need follow their instinct rather than formal guidance.
You may also be interested in...
Little has been forthcoming from the European Commission about actions it is taking to get the new European regulatory framework for medical devices and IVDs ready on time. Now the European Parliament wants some answers.
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.
EU member states need to decide some aspects of the EU’s medical device regulations, such as their competent authority and labeling language, for themselves. Here Italy explains its position.