November 02, 2021

Medical Device News – November 2021 latest update

35 minutes

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

In this episode of the Podcast we will review:

IVDR proposal to delay transition periods

Cobalt on medical devices as CMR

Artificial Intelligence

MDCG guidance

Notified Body overview

Check links below

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing 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

Implementing Rolling Plan https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_rolling-plan_en.pdf

IVDR proposal for new transition period: https://ec.europa.eu/commission/presscorner/detail/en/ip_21_5209 https://ec.europa.eu/commission/presscorner/detail/en/qanda_21_5210

PDF Q&A: https://ec.europa.eu/commission/presscorner/api/files/document/print/en/qanda_21_5210/QANDA_21_5210_EN.pdf

Draft Regulation: https://ec.europa.eu/health/sites/default/files/md_newregulations/docs/md_2017-746-regulation_2021-amendment_en.pdf

ANSM: From October 1st 2021 Cobalt as CMR following 2020/2017: https://ansm.sante.fr/actualites/evolution-reglementaire-impactant-les-dispositifs-medicaux-qui-contiennent-du-cobalt

Listed on CLP 1272/2008 Annex VI: https://eur-lex.europa.eu/legal-content/FR/TXT/?uri=celex%3A32008R1272

Guideline to justify CMR is called SCHEER which provides elements to justify with benefit/risk analysis. https://ec.europa.eu/health/sites/default/files/scientific_committees/scheer/docs/scheer_o_015.pdf

TEAM NB – Proposal for Notified Body Opinion Template for Article 117: https://www.team-nb.org/wp-content/uploads/2021/10/Team-NB-PositionPaper-Article117-NB-Opinion-Template-V1.pdf

TEAM NB – European Artificial Intelligence: https://www.team-nb.org/wp-content/uploads/2021/10/Team-NB-PositionPaper-Artificial-Intelligence.pdf

UK MHRA – US, Canada and UK identified 10 guiding principles for AI softwares https://www.gov.uk/government/publications/good-machine-learning-practice-for-medical-device-development-guiding-principles

UK MHRA – Consultation on Futur Regulation https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom

UK MHRA – Infusion Pump T34 from BD https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1026856/T34_syringe_pump_guidance_for_gov-uk.pdf

MHRA Board meeting held in public – eventbrite: https://www.eventbrite.co.uk/e/mhra-board-meeting-held-in-public-tickets-195778337277

Turkey

EU MDR 2017/745 – May 2021 https://titck.gov.tr/storage/Archive/2021/announcement/Ek1TbbicihazGBOKbeyanmetni_83778294-b01e-47a2-b868-e33c1dd02bc3.pdf

EU IVDR 2017/746 – Sept 2021 https://titck.gov.tr/storage/Archive/2021/announcement/Ek2InvitroGBOKbeyanmetni_1d33cd35-632a-4abb-87ea-803ef67f4977.pdf

Philippine – FDA Circular for retailers of Medical Devices – License to sell medical devices is needed https://www.fda.gov.ph/wp-content/uploads/2021/10/FDA-Circular-No.2021-021.pdf • Thailand FDA – HAS Singapore – Regulatory reliance program: https://bit.ly/3nN1PBo

Japan – PMDA update https://www.pmda.go.jp/files/000243366.pdf

Online platform to learn the regulation in Japan: https://www.pmda.go.jp/english/int-activities/training-center/0005.html

Other course: https://www.pmda.go.jp/english/int-activities/training-center/0006.html

EVENTS

ACRAS – Nov 24th and 25th https://acras.me/

NOTIFIED BODIES

Overview of Notified Body Situation https://ec.europa.eu/health/sites/default/files/md_newregulations/docs/notifiedbodies_overview_en.pdf

GUIDANCE

MDCG 2021-24 – Classification https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-24_en.pdf

MDCG 2021-25 Legacy devices https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2021_25_en.pdf

MDCG 2021-26 Article 16 Importer Distr Q&A https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2021_26_en.pdf

PODCAST

Episode 149 – EUDAMED Update with Richard Houlihan https://podcast.easymedicaldevice.com/149/

Episode 150 – CMR substances with Ana Luiza Cassin Duz https://podcast.easymedicaldevice.com/150/

Episode 151 – IVDR is not postponed with Erik Vollebregt https://podcast.easymedicaldevice.com/151/

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