How to deal with Significant Changes within MDR & IVDR with Martin Witte
If you are transitioning from the EU MDD 93/42/EC or 90/385/EEC to the EU MDR 2017/745 or from the IVDD 98/79/EC to the IVDR 2017/745, then you have to be careful with Significant Changes.
In this episode, I’ve asked Martin Witte from TÜV SÜD to give us the point of view of Notified Bodies on Significant changes. When we should consider them, what are the best practices, what to do when we deal with a significant change, and what are the consequences if we are not following the regulation.
So this will be an excellent episode to help you prepare your procedures for significant changes and understand the risks.
Who is Martin Witte?
Martin Witte is Senior Director Strategic Business Development at TÜV SÜD and responsible for the focus topics Active Medical Implants, Cardiovascular, Orthopedic, and Functional Safety/Software.
Prior to his current role, Martin worked as a Lead Auditor, Product Specialist in TÜV SÜD from 2014 on, and took over business development activities with his role as the head of the Active Implants business in 2016.
Prior to his roles in TÜV SÜD, Martin was a Regulatory Affairs Manager at BIOTRONIK, Berlin focusing on heart rhythm management devices and on MRI safety of such devices. His background in Biomedical Engineering which he studied in Hamburg.
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, Podcast, Online courses…
Link
- Martin Witte LinkedIn: https://www.linkedin.com/in/martin-r-witte/
- TÜV SÜD Notified Body page: https://www.tuvsud.com/en
- TÜV SÜD application form: https://bit.ly/3i2Ahnl
- Episode 92- Prepare your MDR audit: https://podcast.easymedicaldevice.com/92
- MDCG 2020-3: Significant changes for your Medical Device: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_guidance_significant_changes_annexes_en.pdf
3 Replies to “How to deal with Significant Changes within MDR & IVDR with Martin Witte”
Comments are closed.
Great topic and guest choice, Monir!
I have a question, with the upcoming once-moved deadline for MDR.
For example, my company got a CE mark this year, but we have some changes to present to our NB in a month, which is 4 months away from the actual MDR application. Does then the MDR 120.3 significant change applies or not?
Thanks a lot.
If your Change is not significant then all is fine.
If your change is significant, executed and approved before the date of application (26 May 2021) then you are still applying MDD and there is no consequence.
If your change is applied after the date of application then you will immediately fall under EU MDR per article 120-3.
Apparently the change you mention is before date of application so you are on the safe side