White Paper

The Clock Is Ticking: Will Notified Body Capacity For The EU MDR Affect You?

Source: Qosina Corporation

By Edwin L. Bills, Consultant for Qosina

Clock Spiral

Explore the progress of the new European Union Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR) and how the lack of Notified Bodies (NB) could affect timely implementation. The deadline is looming larger and some small progress has been made, along with some steps backward. This paper has been updated to reflect recent developments and to bring the current situation into focus.

As of October 2019, there are five approved NBs for the MDR: BSI UK, TÜV SÜD, TÜV Rheinland, DEKRA and IMQ S.p.A. DEKRA is also approved as the first NB for IVDR. However, while the addition of NBs is certainly a positive development, there are still not nearly enough to handle the necessary workload to continue all devices and IVDs on the market, let alone introduce any new products into the European marketplace.

access the White Paper!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Med Device Online? Subscribe today.

Subscribe to Med Device Online X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.


Subscribe to Med Device Online