The latest news on Brexit, Swixit and EU MDR [Medical Device News]
This month on the Medical Device News section of the podcast we will talk about:
- Exits from Europe with Brexit and Swixit
- Conferences that are now mainly going virtual
- Green Belt Certification
- Celebrations
- Notified Body situation with the countdown offered by Michelle Lott
- Standards and guidances
- Podcast
Don’t hesitate to look at the Medical Device News links in the below section to review more in detail each topic.
Don’t forget also to participate in the Green Belt certificate so you can learn more about EU MDR.
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.
Recently, he has created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…
Links
Medical Device News Hot topics:
- MHRA Guidance on Brexit: https://www.gov.uk/guidance/regulating-medical-devices-from-1-january-2021
- Swiss votation on immigration: https://www.euractiv.com/section/justice-home-affairs/news/swiss-voters-refuse-immigration-cuts-eu-sees-great-future-in-relationship/
- FT News on Swiss votation: https://www.ft.com/content/eb22b826-1e37-4b98-96bf-561994eb1ee8
- Angelina Hakim LinkedIn: https://www.linkedin.com/in/angelina-hakim-34b70225/
- Episode 62 – Swixit with Ronald Boumans: https://podcast.easymedicaldevice.com/62
- Episode 63 – Brexit Swixit and Turkxit with Erik Vollebregt: https://podcast.easymedicaldevice.com/63
Conferences:
- MDG premium October 16th – Economic Operators – https://medgroup.biz/calls
- TOPRA Symposium October 6th – 8th – https://www.topra.org/sym2019
Green Belt Certificate:
Celebration:
- 4000k Youtube channel: https://www.youtube.com/c/EasyMedicalDevice?sub_confirmation=1
Notified Body:
- Michelle Lott LinkedIn: https://www.linkedin.com/in/michellelottraqa/
- NANDO database EU MDR 2017/745 NBs: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34
- 3EC International information: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.nb&body_type=NB&refe_cd=NANDO_INPUT_175701
- NANDO database EU IVDR 2017/746 NBs: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35
Standards and guidance’s:
- MDCG meetings: https://ec.europa.eu/health/sites/health/files/md_dialogue/docs/md_events_2020_en.pdf
- MDSAP audit approach: https://www.fda.gov/media/87544/download
Podcast episodes September:
- Episode 92 – Be successful at your MDR and IVDR audit with Martin Witte: https://podcast.easymedicaldevice.com/92/
- Episode 93 – How can GDPR impact Medical Devices with Erik Vollebregt: https://podcast.easymedicaldevice.com/93/
- Episode 94 – How to get some help from regulators with Cliff Bleustein: https://podcast.easymedicaldevice.com/94/
- Episode 95 – How to register ATMP-Device combination products with Margareth Jorvid: https://podcast.easymedicaldevice.com/95/
