Will it be really difficult for IVD manufacturers? [IVDR 2017/746]
We talked a lot about the EU MDR and the difficulty for some manufacturers to transition to this new legislation. But today we will explain why IVDR manufacturers will struggle more. I will explain to you the change in terms of product classification within the IVDR 2017/746. Because of this, a lot of manufacturers that didn’t need a Notified Body before will need one now. And as you may know, as of today, the number of Notified Bodies is not really high. So I hope this episode will help you understand the situation for the IVD business as there is a risk for manufacturers but also for patients.
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 now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…
- Notified Bodies IVR Codes: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R2185&from=EL
- Medtech – IVD symbols: https://www.medtecheurope.org/wp-content/uploads/2020/10/medtech-europe-new-ivd-symbols-for-compliance-with-the-ivdr-october-2020.pdf
- MDCG 2020-16 – IVD classification: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2020_guidance_classification_ivd-md_en.pdf
- Covid-19 Q&A: https://ec.europa.eu/health/sites/health/files/md_sector/docs/covid-19_ivd-qa_en.pdf
- Podcast episode 99 – IVDR Self-testing: https://podcast.easymedicaldevice.com/99/
- Podcast episode 42 – New Rules IVDR: https://podcast.easymedicaldevice.com/42/