February 2021 Update – Medical Devices Remote Audit by the EU

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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…

Links

HOT 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