Medical Device News – May 2020 Review with Monir El Azzouzi

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