Yes, I think the MDR will increase their responsibilities and liabilities, so prices are likely to go up. I don't know what is standard, but I'd definitely get several quotes. For a number of reasons, I'm usually more inclined to go with smaller organizations with focused specialties over large organizations that offer a long shopping list of services across a range of industries. One reason is that the smaller organizations are usually less expensive.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------
Original Message:
Sent: 17-Dec-2019 04:56
From: James Davis
Subject: Regulatory Representative
Thanks Julie. I am looking at just the EU to begin with and have had a rough cost through from Emergo which is £3000 a year! Any idea whether this is standard or not? I am guessing they have all increased their prices with the MDR!
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James
Head of QARA
UK
Original Message:
Sent: 07-Dec-2019 22:33
From: Julie Omohundro
Subject: Regulatory Representative
I think you can safely assume that pretty much all countries will require an authorized local representative. This is a long-standing international practice, not limited to medical devices. I doubt you will find a list with fees, but you might check with Emergo. They offer this service in a number of countries and might be willing to give you cost estimates.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
Original Message:
Sent: 06-Dec-2019 06:15
From: James Davis
Subject: Regulatory Representative
Hi All.
Does anyone know of a resource that would show which countries require a Regulatory Representative for a Medical Device and what the rough costings would be for that country?
I was hoping someone might have this information to hand!
Thanks
James
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James
Head of QARA
UK
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