June 08, 2020

Medical Device News – May 2020 Review with Monir El Azzouzi

36 minutes

https://www.youtube.com/embed/VQTU4MTfDVo?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

In this episode of the podcast, we will review what happened during the month of May 2020 for the Medical Device Industry. And there was a lot.

The agenda:

EU MDR non-anniversary

The IVDR challenge

The Coronavirus

The Easy Medical Device surprise

Notified Body Situation

MDCG guidance

What happened at Easy Medical Device

You can get all the link of all what we talked about below.

Who is Monir El Azzouzi

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. He has made is study in Biomedical Engineering at the ISIFC school in France which is specialized in all Medical Devices aspects for business. He held a brilliant career within major corporate companies like Johnson & Johnson, BBraun Medical, or Bausch + Lomb.

He always worked within Quality and Regulatory Affairs departments which brings him enough experience to support any organization. For that, he decided to create Easy Medical Device to support Medical Device manufacturers to bring compliant products on the market.

Additionally, his objective is also to help the Medical Device community to learn more about the Medical Device Regulation and Standard, and for that, he creates a blog, a YouTube channel, and a podcast where he educates all his followers.

Links

Hot Topics

Erik Vollebregt Blog post: https://medicaldeviceslegal.com/2020

MDR consolidated: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1589797311848&uri=CELEX:02017R0745-20200424

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

Standardization CEN CENELEC: https://ec.europa.eu/growth/tools-databases/mandates/index.cfm?fuseaction=search.detail&id=589#

MIR Form: https://ec.europa.eu/docsroom/documents/41221/attachments/1/translations/en/renditions/native

Covid 19

Switzerland: https://www.swissmedic.ch/swissmedic/en/home/news/coronavirus-covid-19/mu500_00_014d_mb.html

Ireland: http://www.hpra.ie/docs/default-source/default-document-library/hpra-infographic-response-to-covid-19.pdf?sfvrsn=4

MHRA: https://www.gov.uk/government/publications/how-tests-and-testing-kits-for-coronavirus-covid-19-work/for-industry-and-manufactures-covid-19-tests-and-testing-kits

US FDA EUA: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations

Fake Certificates: https://www.team-nb.org/wp-content/uploads/2020/05/TEAM-NB-List-of-on-line-check-for-validity-of-certificates-20200514-1.pdf

Greenlight Guru Virtual Summit – Economic Operators: https://youtu.be/6FF8H5W-NEw

EU MDR Green Belt Certification Program: https://school.easymedicaldevice.com/product/green-belt-eu-mdr-certification-purchase/

Notified Bodies

Vote Notified Body situation: https://www.linkedin.com/posts/melazzouzi_medicaldevices-easymedicaldevice-eumdr-activity-6670306258815332352-9E4K

Team NB Survey: https://www.team-nb.org/wp-content/uploads/2020/05/Team-NB-MD-Sector-Survey-PressRelease-20200505-1.pdf

Notified Body Intertek Medical Sweden: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.pdf&dir_id=34&ntf_id=306148

MDCG Guidance

MDCG 2020-11 – Guidance on the renewal of the designation and monitoring of Notified Bodies under MDD, AIMDD (2020/666) https://ec.europa.eu/docsroom/documents/41421?locale=en

MDCG 2020-10/1 Safety reporting in clinical investigation of Medical devices under the Regulation https://ec.europa.eu/docsroom/documents/41183?locale=en

MDCG 2020-10/2 Clinical Investigation Summary Safety Report Form https://ec.europa.eu/docsroom/documents/41184?locale=en

Podcast

75 – How to get your Digital Health Application reimbursed in Germany with DIGA (Stefan Bolleininger) https://podcast.easymedicaldevice.com/75/

76 – How to get ISO 13485 certified https://podcast.easymedicaldevice.com/76/

77 – What is the Notified Body Situation (Bassil Akra) https://podcast.easymedicaldevice.com/77/

78- What means Sufficient Clinical Data? (Bassil Akra) https://podcast.easymedicaldevice.com/78/

LinkedIn Live

How to register Covid-19 Medical Supplies in the UK? (Helen Erwood) https://www.youtube.com/watch?v=GORGSHszH-E

Medical Device Software: Sufficient Clinical Data under MDR and IVDR MDCG 2020-1 https://www.youtube.com/watch?v=HIycmCuBsi0

How to comply with the GSPR? https://www.youtube.com/watch?v=iaE_gbhfW5U

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