What is the Medical Device News? [March 2021 update]

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This month we will review what happened within the Medical Device Industry and there was some updates.

Here is the agenda:

• EUDAMED
• Covid19
• Language for EU MDR 2017/745
• MHRA virtual manufacturer update
• Australia Nanoparticle consultation
• Singapore Medical device grouping tool
• Saudi Arabia covid 19 update
• Easy Medical Expert
• Green Belt Training
• Notified Bodies
• Approved Bodies
• Events
• Podcast episodes

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

EUDAMED

• EU Commission EUDAMED Legacy devices: https://ec.europa.eu/health/sites/health/files/md_eudamed/docs/legacy_dvc_management_en.pdf
• EUDAMED-DI Free Generator Template: https://eudamed.eu/index.php/eudamed-legacy-device-di-generator/
• MDCG 2019-15 Legacy device https://ec.europa.eu/docsroom/documents/34922/attachments/1/translations/en/renditions/native
• MDCG 2021-1 EUDAMED Harmonized practices: https://ec.europa.eu/health/sites/health/files/md_sector/docs/2021-1_guidance-administrative-practices_en.pdf

COVID 19 Section

• TEAM-NB position paper – Commission Notice 2021/C 8/01: https://www.team-nb.org/it-appears-that-there-are-differences-in-the-approach-between-member-states-and-national-competent-authorities-concerning-the-implementation-the-commission-notice-2021-c-8-01-on-remote-audits-under-th/

• Survey result: https://www.linkedin.com/posts/melazzouzi_medicaldevices-easymedicaldevice-regulatoryaffairs-activity-6761649059909419009-h5u2/

• COVID-19 tests: https://ec.europa.eu/health/sites/health/files/md_sector/docs/covid-19_ivd-qa_en.pdf

• Clinical Trials during Covid-19: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf

OTHER

• Norwegian: https://legemiddelverket.no/Documents/Medisinsk%20utstyr/Spr%C3%A5kkrav/Language%20requirement.pdf

• MHRA Virtual manufacturer Version 3 including elements about Brexit rules:  https://www.gov.uk/government/publications/medical-devices-virtual-manufacturing-replaces-own-brand-labelling/virtual-manufacturing-of-medical-devices

WORLD

• Australia:
  • Consultation on Nanoparticles: https://consultations.health.gov.au/tga/medical-devices-nanomaterials/
  • Mask test results b TGA: https://www.tga.gov.au/testing-face-masks-and-respirators
• Singapore: Introduction of the Medical Device grouping tool: https://consultations.health.gov.au/tga/medical-devices-nanomaterials/
• Saudi Arabia: Support of Medical Devices due to the pandemic http://www.ahwp.info/sites/default/files/Kingdom%20of%20Saudi%20Arabia%20updates_0.pdf

TOOL

• Easy Medical Expert http://easymedicalexpert.com
• Green Belt Certificate 10th Edition: https://school.easymedicaldevice.com/course/gb10

Notified Body

• Instituto Superior di Sanita. https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=311094&version_no=3
• NANDO EU MDR Notified Bodies: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34
• NANDO EU IVDR Notified Bodies: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35
• UK Approved body: https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies/uk-approved-bodies-for-medical-devices

Events

• Virtual Summit Greenlight Guru: March 17th – How to create labels per EU MDR? https://www.linkedin.com/events/eumdr-ivdrtruequalitysummitseri6766032051045986304/

Podcast episodes

• Podcast Episode 114 – What is the QA RA Mindset with Michelle Lott from Lean RAQA https://podcast.easymedicaldevice.com/114/
• Podcast Episode 115 – How to find a QA RA Job with Karandeep Badwal  https://podcast.easymedicaldevice.com/115/
• Podcast Episode 116 – Medical Device Design methods (Waterfall or Agile) Jon speer from Greenlight Guru https://podcast.easymedicaldevice.com/116/

Telegram group:  https://t.me/easymedicaldevice

The post What is the Medical Device News? [March 2021 update] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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