Official Number is now 15 – MDD to MDR + IVDD to IVDR Planning – Elexes
Elexes Medical Consulting

Everyone knows that the advent of MDR was postponed, and the new regulation shall be in full force from May 26, 2021. As we prepare for this change, keeping abreast of updates shall help in efficient planning. 

Another NB GMED just got added to the list of Notified Bodies accredited to do the reviews of technical files under MDR. The addition of more NBs will certainly make the process of transitioning from MDD to MDR more manageable and practical. It’s important to know the differences between MDD and MDR and begin planning for the transition. Elexes shall continue updating the NB list

  • MDR shall be replacing AIMDD and MDD
  • IVDR shall be replacing IVDD 

Here is a timeline to help plan better. It’s important to know that as long as substantial changes are not being made to products, the timeline available for a complete transition is longer than that available for the products that shall undergo substantial changes. However, all new products after 2021 and 2022 under MDR and IVDR respectively shall have to completely comply with the new regulations. 

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