Need of conducting medical trials in European Union

atitheya

atitheya

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#1
#1
A client of mine is a manufacturer and seller of a class II a medical device. He is located outside of the European Union. He now wants to enter the European market and is looking for CE Mark.

Is he required to conduct trials of medical device in the European Union to validate conformance of the medical device?
 
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shimonv

shimonv

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#2
#2
It takes a lot more information to answer this question...
In a nutshell, if you can demonstrate equivalence to exiting CE marked device than there is a case for clinical evaluation report based on literature review; otherwise or if your notified body requires it you need to do a clinical trial. Have a look at the MEDDEV guidance 2.7/1

Shimon
 
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T

twanmul

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#3
#3
The MDR, Annex XIV, 3, indent 3 states:
"Clinical: the device is used for the same clinical condition or purpose, including similar severity and stage of disease, at the same site in the body, in a similar population, including as regards age, anatomy and physiology; has the same kind of user; has similar relevant critical performance in view of the expected clinical effect for a specific intended purpose. "

As long as the data the manufacturer already has meets the required level of rigour and you're able to demonstrate the population is similar, then there should be no issue with using any existing clinical evaluation data they have from use in another market as part of the registration process and conformity assessment under the new regulation within the EU. I'd suggest something along the lines of a "User Profile Assessment," with possibly a comparison of age related, anatomical and physiological profiles of the population of their existing market against the demographic within the EU market.
 
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