February 02, 2021

February 2021 Update – Medical Devices Remote Audit by the EU

21 minutes

https://www.youtube.com/embed/RXLmLbq9mpA?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

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In this monthly episode of the podcast, we do a regulatory intelligence review of what happened monthly.

The agenda for this month is:

Countdown until EU MDR by Michelle Lott (LeanRAQA)

Remote Audit authorized for EU MDR

SURVEY Result

US update on Recognised Consensus Standards

Canada guidance on Vigilance Reporting

Training available

Notified Body Situation

UK Approved Body

Guidance and Standards

PODCAST and LIVE episodes

Look at all the links below.

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 has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

LinksHOT TOPICS

Remote audit Commission Notice 2021/C 8/01 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.C_.2021.008.01.0001.01.ENG&toc=OJ%3AC%3A2021%3A008%3ATOC

Erik Vollebregt Blog https://medicaldeviceslegal.com/2021/01/24/finally-remote-initial-audits-or-not/

TEAM NB is working on a harmonized view regarding the commission notice published https://www.team-nb.org/team-nb-task-force-is-working-on-harmonised-views-on-harmonised-risk-based-approach-regarding-commission-notice-published-today-2/

Podcast episode 33 – https://podcast.easymedicaldevice.com/33/

NEW SURVEY: Under all those circumstances do you think the EU COMMISSION took the right decision. https://www.linkedin.com/posts/melazzouzi_medicaldevices-easymedicaldevice-regulatoryaffairs-activity-6761649059909419009-h5u2

SURVEY result: MDR IVDR postponement: https://www.linkedin.com/posts/melazzouzi_there-were-a-lot-of-requests-related-to-the-activity-6751181775264890880-FWOK/

SURVEY: Swiss/Turkey Certificates: https://www.linkedin.com/posts/melazzouzi_medicaldevices-easymedicaldevice-regulatoryaffairs-activity-6751203793725116416-lPjR/

TRAINING

Qmed Academy: https://qmed-academy.teachable.com/

EUDAMED (Eudamed.eu). https://eudamed.eu/index.php/mdr-eudamed-training-schedule/

QUINIQUE: https://quniquegroup.com/trainings/

Easy Medical Device: https://school.easymedicaldevice.com/course/gb9

NOTIFIED BODY

SGS FIMKO OY (Finland) https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=310591&version_no=17

NANDO MDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34

NANDO IVDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35

UK approved body: ttps://www.gov.uk/government/publications/medical-devices-uk-approved-bodies/uk-approved-bodies-for-medical-devices

PODCAST & LIVE

How to register a Medical Device in Israel with Liat Nadel https://podcast.easymedicaldevice.com/110/

Hot to get the MDR certification for Artificial Intelligence Software’s with Leon Doorn https://podcast.easymedicaldevice.com/111/

How to perform your PMS more easily with Ivan Perez Chamorro https://podcast.easymedicaldevice.com/112/

LINKEDIN LIVE: What is the EU MDR timeline? https://www.youtube.com/watch?v=UB6Ze7pebLY

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