Medical Device News – August 2020 Review (Monir El Azzouzi)
The Medical Device industry is still moving a few steps forward to EU MDR 2017/745. Here is the agenda of this review:
- Cardiac Implantable Electronic Devices (CIED)
- Rolling plan (EUDAMED + Reprocessing of single-use devices)
- Green Belt Certificate (New session in French)
- Notified Body Situation
- New guidance and Standards
- Review of the podcast episodes
In this version, the VIDEO PARODY CLIP was blurred as there are some copyrights to the USA.
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…
- UDI FAQ: https://ec.europa.eu/docsroom/documents/42641?locale=en
- CIED guidance: https://ec.europa.eu/docsroom/documents/37283
- Rolling Plan of August: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_rolling-plan_en.xlsx
- Regulation 2020/1207 Reprocessing of single-use devices: https://eur-lex.europa.eu/eli/reg_impl/2020/1207/oj
- Green Belt Certificate: https://school.easymedicaldevice.com
- DQS MED notified Body: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=308392&version_no=9
New Guidance and Standards
- ISO 14155:2020 Clinical Investigation: https://www.iso.org/standard/71690.html
- LinkedIn Post Helene Quie: https://www.linkedin.com/pulse/revision-iso-14155-available-helene-quie/
- MDCG 2020-14 – MDSAP report: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_2020-14-guidance-mdsap_en.pdf
- MDCG 2020-15 – Eudamed Actor Module: https://ec.europa.eu/health/sites/health/files/md_sector/docs/2020-15-position-paper-actor-registration-module_en.pdf
- Episode 88 – IEC 60601 with Leo Eisner https://podcast.easymedicaldevice.com/88
- Episode 89 – Medical Device Testing with Michael Wetherington https://podcast.easymedicaldevice.com/89
- Episode 90 – Virtual Conferences with TOPRA https://podcast.easymedicaldevice.com/90
- TOPRA symposium: https://www.topra.org/sym2019
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