Medical Device Regulatory Update – February 2020
On this Regulatory Update, we will talk about many diverse topics but here is an outline.
First, we will review the Coronavirus situation and I will also provide you with some fun facts that are happening.
Then we will talk about MDCG committee. We’ll review the guidance issued and the topics they will discuss during this march meeting.
After that, we will discuss the Notified Body Situation. How many are available? Who are the new ones?
Finally, we’ll review some US guidance that are issued and even a Ban of a certain device.
I will also take the opportunity of this review to review all the topics that were discussed on the podcast, and also the LinkedIn Live.
I really hope this will be informative to you.
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…
- MDCG Meeting March 12th, 2020: https://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupMeetingDoc&docid=39327
- Notified Body Norway – DNV GL Presafe AS https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=304712&version_no=4
- Notified Body Ireland – NSAI https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=304908&version_no=9
- Soft (Hydrophilic) daily Wear Contact Lenses (Draft Guidance) https://www.fda.gov/regulatory-information/search-fda-guidance-documents/soft-hydrophilic-daily-wear-contact-lenses-performance-criteria-safety-and-performance-based-pathway
- Guidance Bone Anchors – 510k Submission https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bone-anchors-premarket-notification-510k-submissions
- Ban of Electrical Stimulation Devices (ESDs) for self-injurious or aggressive behavior https://www.federalregister.gov/documents/2020/03/06/2020-04328/banned-devices-electrical-stimulation-devices-for-self-injurious-or-aggressive-behavior
- TOPRA course: https://www.topra.org/TOPRA/TOPRA_Member/Events/Event_Display.aspx?EventKey=MC142020
- Podcast episode 62 – Swixit: https://podcast.easymedicaldevice.com/62/
- Podcast episode 63- Brexit, Swixit, Turkxit: https://podcast.easymedicaldevice.com/63/
- Podcast episode 64 – Clinical Data low-risk device: https://podcast.easymedicaldevice.com/64/
- Podcast episode 65 – Intended Purpose: https://podcast.easymedicaldevice.com/65/
- LinkedIn Live – QMS Implementation for MDR Up-classified Software Medical Devices: https://www.youtube.com/watch?v=HYZJn23C3oc
- LinkedIn Live – ISO 14971: https://www.youtube.com/watch?v=5C2CzApjI_U
- LinkedIn Live – Annex XVI: https://www.youtube.com/watch?v=kpIphE2PVew
- Easy Medical Device Shop: https://easymedicaldevice.com/shop