Checklist – What is important before the EU MDR Date of Application?
Wahoo!! We are close to it now. The EU MDR 2017/745 Date of Application is arriving quickly. So for this episode, I wanted to check with you if you are ready.
I will provide you first with the Scope for this date. Which products have to be ready by May 26th, 2021. Then we will talk about the documents that should be available. This list may not be complete so be sure to review for your product the requirements on the EU MDR. Finally we will talk about what is not mandatory even if people say it is.
Don’t miss also the links that I will provide below as this will help you to understand each of the topics.
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 developed the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…
- Article 117 Drug Device Combination products : https://www.youtube.com/watch?v=x-MZElb-ur0
- Annex XVI products: https://www.youtube.com/watch?v=kpIphE2PVew
- QMS implementation for EU MDR: https://www.youtube.com/watch?v=HYZJn23C3oc
- Clinical Evaluation for low risk devices: https://www.youtube.com/watch?v=rGHXBYxvMqQ
- CER with Product equivalency: https://www.youtube.com/watch?v=xIeL297EOho
- PMCF with Helene Quie: https://www.youtube.com/watch?v=Avhbglq5bvY
- Podcast episode Q&A label: https://www.youtube.com/watch?v=ecigFjReuXU
- How to create a UDI: https://www.youtube.com/watch?v=_kF5GUs_hgo
- Technical Documentation blog: https://easymedicaldevice.com/technical-documentation/
- Declaration of conformity: https://easymedicaldevice.com/declaration-of-conformity/
- Complete guide on Economic Operators: https://easymedicaldevice.com/economic-operators/
- Swixit, Turkxit, Brexit: https://www.youtube.com/watch?v=ym2bQoe620s
- EUDAMED registration: https://www.youtube.com/watch?v=z5KtpAVV-24