Medical Device News – September 2021 Latest Updates

Medical Device made Easy Podcast

This month we will cover a lot of specific rules that are applied in some countries:

• USA
• UK
• France
• Finland
• Switzerland

And then we’ll look at Events planned, Notified Bodies, MDCG guidances released, and the Podcast episodes.

Enjoy!

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 TOPICS

• FDA Shifts to regulating Contrast agents as Devices: https://www.raps.org/news-and-articles/news-articles/2021/8/after-court-defeat-fda-shifts-to-regulating-some-d?utm_source=MagnetMail&utm_medium=Email%20&utm_campaign=RF%20Today%20%7C%209%20August%202021
• UK – Export – FSC https://www.gov.uk/guidance/export-medical-devices-special-rules ○ Bfarm – Real time operating system vulnerabilities: https://www.bfarm.de/SharedDocs/Risikoinformationen/Medizinprodukte/EN/vulnerabilities_realtime_os.html;jsessionid=CBCADA5BC2C5210901042A54A3189117.intranet231?nn=968830
• RAPS article on Bfarm alert: https://www.raps.org/news-and-articles/news-articles/2019/8/operating-system-vulnerabilities-in-many-medical-d
• France: Anticipation potential disruption of products: https://ansm.sante.fr/actualites/indisponibilite-dun-dispositif-medical-lansm-publie-une-procedure-de-gestion-preventive-pour-les-operateurs-du-marche
• Finland: MDR supplementing law: https://www.fimea.fi/web/en/-/laws-supplementing-eu-regulations-on-medical-devices-come-into-force
• Switzerland – Obligation CH-REP importer distributors: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/pflichten-bevollmaechtigte.html
• Easy Medical Device Authorized Representative: https://easymedicaldevice.com

• Events

• GCC September 20th – 22nd – https://www.gccmedtech.com/
• IMDS September 28th – 29th morning CET – https://www.imdsgroup.com/
• Rentrée du DM October 6th – 7th – https://www.larentreedudm.com/
• Medtech Virtual Summit October 18 – 22nd – https://informaconnect.com/medtech-summit/

• Notified Bodies

• NB – GMED for IVDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.pdf&dir_id=35&ntf_id=314017

• Guidance and Standards

• MDCG 2021-21 https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-21_en.pdf
• MDCG 2021-22 https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-22_en.pdf
• MDCG 2021-23 https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-23_en.pdf

• Podcast

• Episode 140 – What can we learn from the first MDR audits? [Martin Witte – TÜV SÜD] https://podcast.easymedicaldevice.com/140/
• Episode 141 – Better to be a Consultant of a Full-time employee? [Smahan Toughrai Tech’Firm] https://podcast.easymedicaldevice.com/141/
• Episode 142 – How to certify a Software as a Medical Device? [Dr. Abtin Rad TÜV SÜD] https://podcast.easymedicaldevice.com/142/

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