August 03, 2021

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

26 minutes

https://www.youtube.com/embed/_AhV5CWgL1s?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

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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