Foreign manufacturer: how to conduct Clinical Investigation?

itscloud

Starting to get Involved
#1
Hi,

Can anyone tell me if clinical investigation is mandatory to be conducted within the EU, or it can be conducted in my own contry?

If it's mandatory, please help me where to start, do i approach the competent authorities first? By email/or?
 
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dgrainger

Trusted Information Resource
#2
Hi,

Yes, as part of a multicentre or multinational study and with the approval of the CA you apply to.

ANNEX XV CHAPTER II - Documentation​
"1.8 identification of the Member States and third countries in which the clinical investigation is to be conducted as part of a multicentre or multinational study at the time of application;"​
 

Cybel

Involved In Discussions
#3
Hi, I'm not an expert on this matter because I'm based in EU and I've made clinical investigations in EU only, but I don't think it is mandatory that clinical investigations are performed in EU to get compliance with MDR. The Whereas 64 states:
Schermata 2021-06-16 alle 13.42.52.png
I suppose that if your clinical investigation conducted in a third country respects the requirements asked by EU, it can be used as well for the compliance of a medical device to MDR.
 

Raisin picker

Involved In Discussions
#4
I suppose that if your clinical investigation conducted in a third country respects the requirements asked by EU, it can be used as well for the compliance of a medical device to MDR
I support that.
You also need to consider that the population (or other circumstances) in your study country might deviate from the EU population in some aspect significant for your device. You then would need a good justification to get your trial data accepted.
I remember a case where some orthopaedic implants were tested in a study somewhere in Asia (could have been hip implants). The population there was, on average, smaller and more petite than your average european person. The study then could not test the largest sizes of the device (in significant numbers). Try to argue that ;-)
 

dgrainger

Trusted Information Resource
#5
CHAPTER VI of MDR has discusses the 'member state' and 'third country' requirements - worth a look. I can't see how you can meet the requirements and perform a CI solely in a 'third country'.
 
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