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2 min reading time
If you’re doing business in Europe, I recommend you download this free report from ICON plc at https://medgroup.biz/ICON-MDR
There’s way too much for me to summarize in the space LinkedIn allows. Here are my oversimplified observations.
• European approvals are going to cost you more and take longer.
• Certification will be required for about 90% of all IVDs, up from 10% today.
• Your products may be reclassified (IVDs into four classes, A through D, outlined in report)…
• … and recertified, and will increase costly clinical monitoring and evidence generation.
• Notified Bodies are (already) overwhelmed. Get in queue immediately. (See our group discussion, “Need an NB? Good Luck! at https://medgroup.biz/NB-luck.)
• Defective devices will cost you more and will require insurance and greater scrutiny of outsourced production.
• Most devices and IVDs will require post-market surveillance and performance assessments.
• Regulations may be applied outside the EU and in the UK after Brexit.
• Pre-approval clinical studies rather than equivalency statements for many new implants.
• The “medical device definition” will now include devices for support of conception and products specifically intended for cleaning, disinfection, or sterilisation.
• Importers, distributors, and authorized reps must maintain records of devices through new UDI codes.
• Something about EUDAMED submissions that went over my head. (Just sayin’.)
Download the report at https://medgroup.biz/ICON-MDR. It will save you a lot of time researching this on your own; it tells you what you need to know.
Thanks for preparing it and sharing with the group, ICON.
Free Webinar today: Computational Modeling for Medical Device Development and FDA Certification at https://medgroup.biz/comp-modeling
Probably will create a book out of this. Add your voice: https://medgroup.biz/collective-wisdom
Make it a great week.
John E. Hamm
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