How to create a Label under MDR? (Questions & Answers)
This podcast episode is following a presentation I have made during the Greenlight Guru Summit on EU MDR and IVDR. I have explained how to create a label that fulfills the requirements of the EU MDR. I have placed on the show notes the link to it. After the session, I have received a lot of questions and I didn’t have the time to answer all of them, so I said to myself that maybe it would be better to have 1 podcast episode instead of me answer per email to each person. I am sure that the question people asked is common to other persons so let’s review that together.
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, Podcasts, Online courses…
- Medtech Europe: https://www.medtecheurope.org/resource-library/use-of-symbols-to-indicate-compliance-with-the-mdr/
- BSI Presentation: https://www.bsigroup.com/globalassets/meddev/localfiles/it-it/webinars/bsi-md-symbols-and-information-to-be-provided-by-the-manufacturer-webinar.pdf
- Greenlight Guru presentation: https://podcast.easymedicaldevice.com/wp-content/uploads/2021/03/Create-a-Label.pdf
- Greenlight Guru replay: https://mdr.greenlight.guru/talks/how-to-create-medical-device-labels-per-eu-mdr/
- The overriding ISO site for a log in search: https://www.iso.org/standards.html
- The MDCG – Landing page on Guidance documentation: https://ec.europa.eu/health/md_sector/new_regulations/guidance_en
- The EU Fact Sheet Landing page: https://ec.europa.eu/health/md_newregulations/publications_en
- The Online Browsing Platform for symbol search: https://www.iso.org/obp/ui/#search