The Governments of the European member states designated some organizations known as Notified Body who are being found competent to make independent judgments about whether or not a Medical Device complies with new Medical Device Regulation (MDR) and Invitro Diagnostic Regulation (IVDR).
New EU MDR and IVDR qualification process is going on and more notified Bodeies will be added. Up-to-date information of notification status, NB contact details and scope can be found from
MDR qualified Notified Bodies can be found in NANDO database.
IVDR qualified Notified Bodies can be found in NANDO database.
These Bodies are restricted to provide advice and assistance to clients whose products are being tested and certified by them. As consultants we believe that we can offer a better and cheaper service to clients without any restrictions.
We normally takes turnkey projects, based on the repeated need of industry – “single point contact” Where we place business with Notified Bodies on behalf of clients.