The current approach: "Bottom-up" is wrong. All NB should have been required to set a plan for all their devices a schedule for MDR review. Rather than an ad hoc scramble of companies vying to get into a schedule for review the NB should be in control and dictating the process.
As I present to investors and the C Level it's embarrassing to not know when we will be MDR reviewed. It feels like Black Friday in the USA when the stores open their doors and shoppers trample one another to get the prized gifts.
------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets -
https://www.twitch.tv/edosani------------------------------
Original Message:
Sent: 21-Mar-2022 15:11
From: Anonymous Member
Subject: French, German medtech groups call for extension of MDR transition period
This message was posted by a user wishing to remain anonymous
This isn't surprising. There should be more requests for extensions for both the new MDR and IVDR regulations. I do not think many realize the bottlenecks that will be caused, in addition to the already depleted and constrained resources due to the global pandemic. Really there should have been a more organized approach to this by requiring a phased approach or even requiring certain classes of devices, certain countries or by the company's first initials to transition first then another after that, into the new regulations.
Let's see if the NBs will be able to keep up and still do a good job.
Original Message:
Sent: 19-Mar-2022 11:28
From: Vineet Sarin
Subject: French, German medtech groups call for extension of MDR transition period
This news should stimulate some interesting discussion!
https://www.medtechdive.com/news/french-german-medtech-groups-extension-mdr/620551/
------------------------------
Vineet Sarin PhD
President & CEO
Camarillo CA
United States
------------------------------