July 06, 2020

Medical Device News – June 2020 Update

25 minutes

https://www.youtube.com/embed/IrdZAGBSV8I?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

In the Medical Device News segment of the podcast, we will talk about what happened during the month of June. Each month we imagine that there is not a lot to say but each month we get some surprises. On the Agenda we have:

The Coronavirus situation for Medical Device Supplies

The MDR IVDR rolling plan. This includes a trailer for a Telenovela

The Green Belt Certification Program

The Notified Bodies Situation

New Standards and MDCG Guidances

What happened at Easy Medical Device

All the links for the sources of the information provided are on the below section

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 company 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

Hot Topics

Notified Body Covid 19 survey- https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_survey-conformity-assess-covid-19.pdf

List of Covid19 Essential Medical Devices (MDs and IVDs): https://www.team-nb.org/wp-content/uploads/2020/06/NBM-036-20-List-of-COVID-19-essential-Medical-Devices-final.pdf

Covid19 In Vitro Diagnostic Devices and Test Methods Database: https://covid-19-diagnostics.jrc.ec.europa.eu/devices/2#form_content

MDR and IVDR implementation measures rolling plan: https://ec.europa.eu/docsroom/documents/41501?locale=en

Erik Vollebregt Blog post: https://medicaldeviceslegal.com/2020/06/20/standardisation-request-for-mdr-and-ivdr-refused-now-what/

LinkedIn Post on CEN CENELEC refusal of Harmonized Standard Mandate: https://www.linkedin.com/posts/mariogabriellicossellu_mdcg-standards-ugcPost-6679841091816095744-Vn7Z

Green Belt Certification Program: https://school.easymedicaldevice.com/shop/

Notified Body Situation

IVDR: TÜV SÜD Product Service GmbH Zertifizierstellen: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=307788&version_no=19

Standard and Guidance

ISO/TR 24971:2020. https://www.iso.org/standard/74437.html

MDCG 2019-16 Guidance on Cybersecurity for Medical Devices https://ec.europa.eu/docsroom/documents/41863?locale=en

MDCG 2018-3 Rev 1 Guidance UDI for systems and procedure packs: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_guidance_udi_spp.pdf

MDCG 2020-12 Transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product […] as well as on devices manufactured using TSE susceptible animal tissues: https://ec.europa.eu/docsroom/documents/41622?locale=en

Podcast – LinkedIn Live

Episode 80: How to execute an Internal Audit https://podcast.easymedicaldevice.com/80/

Episode 81: How to perform Process Validation for Medical Devices: https://podcast.easymedicaldevice.com/81/

Episode 82: The Secret to be EU MDR certified: https://podcast.easymedicaldevice.com/82

How to be the best at CAPAs – Karandeep Badwal: https://youtu.be/zWK1U7d2awY

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