Implement MDR QMS & Lodge NB ApplicationImplement MDR QMS & Lodge NB ApplicationImplement MDR QMS & Lodge NB ApplicationImplement MDR QMS & Lodge NB Application
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Regulation 2023/607 Published
April 7, 2023
Have Signed Agreement with Notified Body
April 13, 2023

Implement MDR QMS & Lodge NB Application

April 13, 2023

By today, manufacturers of MDD/AIMDD legacy devices must have:

 

  1. implemented a quality management system as outlined in MDR Article 10(9) and
  2. formally lodged an application with a Notified Body for the device. Otherwise, the device no longer qualifies as a legacy device under the extension. 

NOTE: Class III implantable custom-made legacy devices are not required to implement an MDR to the QMS by this deadline. However, they are required to have formally lodged an application with a Notified Body by this date.

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