Medical Device News – August 2021 Regulatory Update [MDR & IVDR]

Medical Device made Easy Podcast

On the agenda for this month Episode we will talk about the latest news and here are few topics that I will present to you:

• Team-NB Position Paper
• Harmonized Standards
• Free ISO standards
• MHRA guidance on Software as Medical Devices
• Training EU MDR
• Green Belt in August
• Notified Bodies situation
• MDCG guidances
• Easy Medical Device Podcast episodes

Don’t miss all the links at the bottom.

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…

Links from the Video

• HOT TOPIC
  • Team-NB position paper: Risk-based approach for medical devices exempted from an implant card and information to be supplied to the patients with an implanted device: https://www.team-nb.org/wp-content/uploads/2021/07/Team-NB-PositionPaper-ImplantCard-202107020.pdf
  • Harmonized Standard IVDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021D1195
  • Harmonized Standards MDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021D1182
  • Episode 92 – How to prepare MDR audit with Martin Witte https://www.youtube.com/watch?v=Oa7jwL-HxgI
  • EU Common list of Covid-19 Rapid antigen test: https://ec.europa.eu/health/security/crisis-management/twg_covid-19_diagnostic_tests_en
  • Free ISO standards for Covid-19: https://www.iso.org/covid19?fbclid=IwAR1bUVGOr2Tv84Og4fiI0wsSCQi9XKD-Iw-j5QBifNZTTWKVluW1Kv8vqyw
  • MHRA: Guidance on Medical Device Stand-alone software including apps: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/999908/Software_flow_chart_Ed_1-08b-IVD.pdf
  • Green Belt Certification 14th Edition: https://school.easymedicaldevice.com/course/gb14/
• NOTIFIED BODIES
  • EU MDR Notified Body: Eurofins Product Testing S.r.l: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=313745&version_no=4
  • EU MDR Notified Body: KIWA CERMET S.P.A.: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=313661&version_no=10
• GUIDANCE AND STANDARDS
  • MDCG 2021-20 – Instructions on generating CIV-IF for MDR Clinical Investigation: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-20_en.pdf
  • MDCG 2021-15 – Conformity assessment body. Application form applying for NB under MDR: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-15_en.docx
  • MDCG 2021-16 – Conformity assessment body. Application form applying for NB under IVDR: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-16_en.docx
  • MDCG 2021-17 – Conformity assessment body. Applied-for scope MDR: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-17_en.docx
  • MDCG 2021-18 – Conformity assessment body. Applied-for scope IVDR: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-18_en.docx
  • MDCG 2021-19 Guidance not integration of the udi within an organization Quality Management System: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_2021-19_en.pdf
  • MDCG 2021-14 Explanatory note on IVDR codes: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2021-14-guidance-ivdr-codes_en.pdf
  • MDCG 2021-13 rev 1 : Q&A EUDAMED registration: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2021-13_q-a-actor_registr_eudamed_en.pdf
• EASY MEDICAL DEVICE activities
  • Episode 136 – How to interpret the first Expert Panel Opinion? Bassil Akra https://podcast.easymedicaldevice.com/136/
  • Episode 137 – System and Procedure Pack the RETURN with Erik Vollebregt https://podcast.easymedicaldevice.com/137/
  • Episode 138 – How to implement Vigilance Reporting for MDR and IVDR https://podcast.easymedicaldevice.com/138/

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