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?
Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.
After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world.
He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses…
- Monir El Azzouzi LinkedIn: https://www.linkedin.com/in/melazzouzi/
- Episode 99 – Self-testing: https://podcast.easymedicaldevice.com/99
- Episode 121 – Why will it be difficult for IVDR manufacturers: https://podcast.easymedicaldevice.com/121
- Nando Database IVDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35
- Nando Database IVDD: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=20
- Q&A Covid19 Tests: https://ec.europa.eu/health/sites/default/files/md_sector/docs/covid-19_ivd-qa_en.pdf
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