EU Class IIa Clinical Trials - Quality Requirements

[lewisking34]

Hi All!

I've familiarised myself with CE technical files (Class IIa eye drops), mainly through looking at my predecessors work, however now it's up to me.

I'm having trouble finding out what quality documents are required in order to safely proceed with a clinical trial/ what the MHRA & Notified Bodies expect to be presented.

Are 3 manufactuing process validation batches required (commercial size), or can we continue with one small batch which is the size to cover the trail?

What stability length of data is needed for a 3 months or 6 months of clinical trial?

Finally, is there a document out there which provides guidance on the quality documents required for technical files, and clinical investigations?

All the best,
Lewis

 

[rob73]

Lewis
Not sure if this will help but......
https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-device

Rob

 

[Ronen E]

Hi Lewis, welcome to the Cove

I'm having trouble finding out what quality documents are required in order to safely proceed with a clinical trial/ what the MHRA & Notified Bodies expect to be presented.

Are 3 manufactuing process validation batches required (commercial size), or can we continue with one small batch which is the size to cover the trail?

The requirements for clinical trials (clinical investigation) are listed in the MDD Annex X section 2.

What stability length of data is needed for a 3 months or 6 months of clinical trial?

In my opinion you should have stability data covering at least the maximum length of the trial + the time from completing manufacturing to actual use. Real time aging would increase confidence and might smooth the approva process, but if the device is not high-risk possibly accelerated aging test data will be acceptable.

Finally, is there a document out there which provides guidance on the quality documents required for technical files, and clinical investigations?

For the recommended contents of a Technical File, see BSI's best practice guide.

Cheers,
Ronen.

 

[lewisking34]

Thanks for the replies, much appreciated.

Lewis