K
KieranConlon1
Hi,
I've been a member of the cove for some time now and I've found it a great source of debate and information, so a big thank you to all who contribute.
I have a query which I hope someone can help me with. I work for a small medical device company in the UK and we are going to look for CE mark approval for a IIa device in the near future. As part of the submission we may have to complete a Clinical Investigation at multiple sites within the UK. I would like to know if at the time of submission to the MHRA, if we have to list all the sites we are going to use for the trial? I understand that we are able to make amendments to the investigation after submission, I would like to know if adding sites later would be seen as a significant change?
Secondly there is a small chance we may also use sites in Germany, if so would this affect the answers to the above questions?
Thanks for your help
I've been a member of the cove for some time now and I've found it a great source of debate and information, so a big thank you to all who contribute.
I have a query which I hope someone can help me with. I work for a small medical device company in the UK and we are going to look for CE mark approval for a IIa device in the near future. As part of the submission we may have to complete a Clinical Investigation at multiple sites within the UK. I would like to know if at the time of submission to the MHRA, if we have to list all the sites we are going to use for the trial? I understand that we are able to make amendments to the investigation after submission, I would like to know if adding sites later would be seen as a significant change?
Secondly there is a small chance we may also use sites in Germany, if so would this affect the answers to the above questions?
Thanks for your help