We are looking for EU authorised Representative for both Class I and Class IIb devices

S

sherin marshiyana

Registered
#1
#1
Hello all,

To introduce ourselves, we design and develop radiology and radiotherapy of Class IIb devices in the market. Inline to it, we are looking for EU authorised Representative for both Class I and Class IIb devices. Could you please suggest an EU Auth Rep as per EU regulation post brexit ?

Thanks in advance !!

Regards,
Sherin
 
GAGEpack - Gage & Calibration Management
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P

primavesvera

Involved In Discussions
#2
#2
When we were looking for one, I consulted this source: EAAR | Members
I wouldn't recommend ours, because he was cheap and that's the corresponding level of service we are getting.

Regarding the part "as per EU regulation post brexit", I am not sure what are you referring to, to the UK Responsible Person you will need to have if you want to sell the devices there or something else.
 
P

Philip B

Involved In Discussions
#3
#3
I think Emergo are the largest EU Authorised Representative. We use Advena Ltd who seem ok although we have only just started with them.
 
Mikilk

Mikilk

Involved In Discussions
#4
#4
primavesvera said:
When we were looking for one, I consulted this source: EAAR | Members
I wouldn't recommend ours, because he was cheap and that's the corresponding level of service we are getting.

Regarding the part "as per EU regulation post brexit", I am not sure what are you referring to, to the UK Responsible Person you will need to have if you want to sell the devices there or something else.
Click to expand...

We can provide you with the EU Rep through our offices located in Germany and Ireland, also with UK responsible person and MHRA registration through our UK branch. Our group provides EU rep services (among others) since 1995.
 
P

primavesvera

Involved In Discussions
#5
#5
Mikilk said:
We can provide you with the EU Rep through our offices located in Germany and Ireland, also with UK responsible person and MHRA registration through our UK branch. Our group provides EU rep services (among others) since 1995.
Click to expand...
Which company do you represent?
 
S

sherin marshiyana

Registered
#7
#7
Hi all,

Many thanks for your response.

Inline to it, Is it mandate to change EU Authorised Representative before January 2021 ? Please help us on the same.

Regards,
Sherin
 
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