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.

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Free Webinar today: Computational Modeling for Medical Device Development and FDA Certification at https://medgroup.biz/comp-modeling

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Probably will create a book out of this. Add your voice: https://medgroup.biz/collective-wisdom

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Make it a great week.

Joe Hage
Medical Devices Group Leader

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Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Ken Buroker, I believe they chose to exclude email domain names such as yahoo, gmail, aol, etc. because they want your business email address.

Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
It’s working for me but here is the entire address: http://www.iconplc.com/services/medical-device/mdr-and-ivdr-are-coming-are-you-prepared/

Robert Mogel
International Sales and Marketing Expert
The fact that European approvals are going to cost more and take longer can also translate into more opportunities for your company. This will weed out the companies that are less serious about selling in the EU and create an environment of less competition for your product.

Ken Ludzack
UDI and PEPPOL Lead at UDI Global Solutions, Inc.
Robert Mogel Agreed those who make the commitment to comply will create a business advantage for themselves as others drag their feet or debate the implications.

Beatrice Hamblin
FR|ENG|DEUTSCH Project Coordinator | Public & Private Tender Specialist | Беатрис Хамблии
Thanks for the info Joe.

Bruce Beardsell
IT Director – EMEA R&D Medical Devices at Johnson & Johnson
Thanks Joe – am I the only one having trouble accessing the link?

John E. Hamm
Project Manager Specializing in Medical Device and Pharmaceutical Industries
Anyone else have problems downloading this?

Ken Buroker
Retired.
The link works for me but won’t let me download. After filling out their (ICON Plc) download request form, it keeps saying I haven’t entered an email address and won’t let me proceed. Any suggestions?