MDR Medical Device Notified Bodies

Notified Bodies ( Notified Body)

The Governments of the European member states designated some organizations known as Notified Bodies 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).

Notified Bodies qualified for MDR and IVDR CE Certification

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.

I 3 CONSULTING role as Regulatory Consultants....

  1. Find the Notified Body for client based on budget and internal readiness.
  2. Prepare technical file on behalf of client and submit to Notified Body.
  3. Coordinate with Notified Body and reply for review comments
  4. Accompany auditors from European Countries to various other countries.

No matter where you are? Which country? Which city? What Device? Leave the Job I 3 CONSULTING!!!

Know approximate fee click here.

Notified Bodies Qualified under MDR CE Marking

01

BSI Assurance UK Limited

0086

02

DEKRA Certification GmbH

0124

03

IMQ Instituto Italiano S.P.A

0051

04

TUV SUD GmbH

1023

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