Latest / Medical Device made Easy Podcast
How to manage the IVDR transition period? [IVDR 2017/745]
We are at 9 months of the EU IVDR 2017/746 date of application. So let’s t talk of the Transition period for such products. We have done that also for MDR 2017/745 when the date was nearly due.
So today we’ll tell you about:
Differences between IVDD 98/79/EC and IVDR
The Hard Transition Period – The Soft Transition Period
The UDI transition period – The Notified Body situation
A simulation on submission timeline to a Notified Body
If you have any need of support for your projects don’t hesitate to contact me. I am sure we can help you.
Who is Monir El Azzouzi?…
The skinny
The skinny isn't ready yet — notes appear once the transcript is processed.