The new Medical Device Regulation (MDR), which becomes fully applicable on May 26, 2021, will give Europe an up-to-date and internationally applicable regulatory framework that is more in line with regulations for medical devices in the rest of the world.

The transition to MDR and the In Vitro Diagnostic Regulation (IVDR, May 2022) will be challenging for everyone involved, as the new regulations put stricter requirements on both manufacturers and notified bodies.

In collaboration with NDAs Director of Medical Devices Dr Tina Amini, BioStock have published an article series about the changes in the regulatory landscape for medical devices. The series, in four consecutive parts, covers the key changes that accompany MDR/IVDR and the challenges that will effect medical device manufacturers.

Part I: An introduction to the upcoming changes

Part II:  Key changes in MDR

Part III: Key changes in IVDR

Part IV: Notified Bodies – potential bottleneck

 

To provide deeper insights into the Medical Device Regulation (MDR), Dr Tina Amini has created a 5 part webinar based training series. 

Are you ready for the new EU Medical Device Regulation?

 

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