Medical Device News: The July 2021 Update [MDR IVDR FDA SFDA]

In this episode of the podcast, we will provide an update on the Medical Device industry for the period June July 2021.

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…

Links

• Joint implementation and preparedness plan for Regulation MDR 2017/745 on IVDR: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_joint-impl-plan_en.pdf
• TEAM-NB: CIRCABC Remote Audit Analysis: https://www.team-nb.org/wp-content/uploads/2021/06/CIRCABC-Remote-Audit-Analysis-May-2021.pdf
• Q&A for applicants, MAH of medicinal products with respect to MDR and IVDR: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu/745-eu-2017/746_en.pdf
• Drug Device Dossier template: https://school.easymedicaldevice.com/product/drug-device-tech-doc/
• The First opinion of the scientific panels in the fields of medical devices: https://ec.europa.eu/health/sites/default/files/md_expertpanels/docs/2021-000201_nb0483_opinion.pdf
• Webinar: Respirators and other PPE during Covid 19: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-series-respirators-and-other-personal-protective-equipment-ppe-health-care-personnel-use
• Medwatch Adverse experience reporting (AER): https://www.federalregister.gov/documents/2021/06/30/2021-13943/agency-information-collection-activities-proposed-collection-comment-request-medwatch-the-food-and
• Virtual Public Workshop – Spinal Device Clinical Review: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/virtual-public-workshop-spinal-device-clinical-review-09172021-09172021
• Dekra Certification B.V. (NB 0344): https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=313231&version_no=22
• MDCG 2021-12 – FAQ on the European Medical Device Nomenclature EMDN: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_2021-12_en.pdf
• EMDN Q&A: https://ec.europa.eu/health/sites/default/files/md_topics-interest/docs/md_q-a_emdn_en.pdf
• MDCG 2021-10 – The status of Appendix E-1 of IMDRF N48: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_2021-10_en.pdf
• IMDRF udi: http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-190321-udi-sag.pdf
• MDCG 2021-11 – Guidance on Implant Card “Device Types”: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_2021-11_en.pdf
• MDCG 2019-8 v2 – Guidance document Implant Card: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2019_8_implant_guidance_card_en.pdf
• MDCG 2021-13 – Q&A on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, EAR, importer: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2021-13_q-a-actor_registr_eudamed_en.pdf
• SFDA: MDS-G11 Guidance on approval requirements for medical devices advertising: https://www.sfda.gov.sa/sites/default/files/2021-06/MDS-G11ar_en2.pdf
• Episode 131: How to perform a Biological Evaluation for Medical Devices with Ana Luiza Cassin Duz: https://podcast.easymedicaldevice.com/131/
• Episode 132: How to perform a good Clinical investigation with Helene Quie: https://podcast.easymedicaldevice.com/132/
• Episode 133: How intellectual property is linked to the Medical Device Regulation with Stephen Carter: https://podcast.easymedicaldevice.com/133/
• Episode 134: How to build your State-of-the-art with Hakan Inan: https://podcast.easymedicaldevice.com/134/
• Linkedin Live: How to place your UDI on your Medical Device with Christian Söhner: https://www.youtube.com/watch?v=cddwXCf_8e4
• Linkedin Live: Best practices to develop a Medical Device Software: https://www.youtube.com/watch?v=8CqSO_B6_zk