https://www.youtube.com/embed/PSk7JtreZvg?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

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

Here is the agenda:

• EUDAMED

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…

EUDAMED

• EU Commission EUDAMED Legacy devices: https://ec.europa.eu/health/sites/health/files/md_eudamed/docs/legacy_dvc_management_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/

TOOL

• Easy Medical Expert http://easymedicalexpert.com

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

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/

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