How to implement Vigilance Reporting for MDR and IVDR?
Within this Masterclass, I will explain to you how to implement a vigilance reporting system with all the links for all the documents we talk about.
Vigilance reporting is a system that you need to have in place for your Quality Management System even if you are still MDD compliant.
If you get a serious incident or a Field Safety Corrective Action (FSCA) then below are the steps to follow.
In this episode of the podcast, we will talk about
- What to do when there is an incident?
- When to report?
- Who to report to?
- How to report?
- Field Safety Notice
- Significant Changes
Below you will have all the links.
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 has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…
Links from the Video
- Q&A MIR form https://ec.europa.eu/docsroom/documents/41322/attachments/1/translations/en/renditions/native
- MIR Form: https://ec.europa.eu/docsroom/documents/41681/attachments/1/translations/en/renditions/native
- FSN Form: https://ec.europa.eu/docsroom/documents/32521/attachments/1/translations/en/renditions/native
- FSN – Customer reply: https://ec.europa.eu/docsroom/documents/32516/attachments/1/translations/en/renditions/native
- FSN Distributor/Importer reply: https://ec.europa.eu/docsroom/documents/32517/attachments/1/translations/en/renditions/native
- FSN Q&A: https://ec.europa.eu/docsroom/documents/31933/attachments/1/translations/en/renditions/native
- IMDRF terminologies for categorized Adverse Event Reporting (AER): http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-200318-ae-terminologies-n43.pdf
- IMDRF annexes: http://www.imdrf.org/documents/documents.asp
- Periodic Summary Report (PSR) form: https://ec.europa.eu/docsroom/documents/32305/attachments/7/translations/en/renditions/pdf
- IMDRF Trend Reporting Guideline: http://www.imdrf.org/docs/ghtf/final/sg2/technical-docs/ghtf-sg2-n36r7-2003-manufacturer-trend-reporting-adverse-event-030101.pdf
- MDCG 2020-3 Significant changes: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_guidance_significant_changes_annexes_en.pdf
- Medtech Europe revised Incident Reporting form: https://www.medtecheurope.org/news-and-events/news/revised-manufacturer-incident-reporting-form-and-new-vigilance-related-guidance-documents-published/
- Cardiac implantable Electronic Devices (CIED) – Guidance on the vigilance system: https://ec.europa.eu/docsroom/documents/37283?locale=en
- Breast Implants – Guidance on the vigilance system: https://ec.europa.eu/docsroom/documents/37283?locale=en