Medical Device News – January 2021 Update (Monir El Azzouzi)
HAPPY NEW YEAR 2021 and all my best wishes to you and your family.
Within this Medical Device News monthly episode of the podcast, we are reviewing the situation on:
- Brexit and the need for UK Responsible person
- Swixit and Turkxit
- EUDAMED and PRRC information made public
- Team NB position papers
- Training – Notified Body situation
- UK Approved Body situation
- MDCG guidance
- Podcast review
Don’t forget that Easy Medical Device can be your UK Responsible Person or also your EU REP contact us at UKREP@easymedicaldevice.com
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 companies 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.
- UK Rep from Jan 1st, 2021: https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market-from-1-january-2021
- Easy Medical Device UK Rep: https://easymedicaldevice.com/uk-responsible-person/
- Erik Vollebregt Brexit post: https://medicaldeviceslegal.com/2020/12/28/the-brexit-deal-whats-not-in-it-for-the-medical-devices-industry/
- Survey Swixit Turkxit: https://www.linkedin.com/posts/melazzouzi_medicaldevices-easymedicaldevice-regulatoryaffairs-activity-6751203793725116416-lPjR
- Rolling Plan: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_rolling-plan_en.pdf
- EUDAMED PRRC question: https://www.linkedin.com/posts/ronald-boumans-34790055_eudamed-prrc-gdpr-activity-6745368549667155969-RzNv
- TEAM-NB Drug-Device Position Paper: https://www.team-nb.org/wp-content/uploads/2020/12/Team-NBPosition-Paper-Art117SubChangeLifeCycleMngt-202012.pdf
- MDCG 2020-3 on Significant changes: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_guidance_significant_changes_annexes_en.pdf
TRAINING:
- Green Belt Certificate: https://school.easymedicaldevice.com/gb/
NOTIFIED BODIES:
- NANDO EU MDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34
- TEAM NB Expiring certificates: https://www.team-nb.org/wp-content/uploads/2020/12/Team-NB-PositionPaper-ExpiringCertificates-20201215.pdf
- Survey: EU MDR & IVDR postponement: https://www.linkedin.com/posts/melazzouzi_there-were-a-lot-of-requests-related-to-the-activity-6751181775264890880-FWOK
- The UK approved bodies: https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies
GUIDANCES:
- MDCG guidance Lenses 2020-18: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2020_18_en.pdf
- Ongoing guidance: https://ec.europa.eu/health/sites/health/files/md_sector/docs/mdcg_ongoing_guidancedocs_en.pdf
PODCAST:
- How to register a Medical Device in Mexico https://podcast.easymedicaldevice.com/106/
- How to deal with Significant Changes with Martin Witte https://podcast.easymedicaldevice.com/107/
- How Easy Medical Device can help you? https://podcast.easymedicaldevice.com/108/
