Multi site Clinical Investigation For CE Mark Application - Class IIa Device (UK)

[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

 

[Stijloor]

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

Can someone help?

Thank you!!

Stijloor.

 

[SteveK]

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

Hi Kieran,

First off you seem unsure about the clinical investigation requirements (or not). I would too for a Class IIa device. Are you certain you do not mean a clinical evaluation?

Steve

 

[yana prus]

Hi,

As appears in the Guidance Note 1 - Guidance Notes for manufacturers on clinical investigations to be carried out in the UK, all proposed changes to the investigation relating to the investigational institution must be notified to the competent authority.

Hope that heps.

Yana