Regulatory Open Forum

Hi Community,

I would appreciate your help and thoughts on this.

Can we use clinical trial protocol, results and reports to support clinical performance of IVD, novel IVD?

 is it obligation to have clinical trail study managed under eTMF? is eTMF auditable? i.e., should we expect notified body to audit this?

i am trying to understand how clinical trail can be used within technical file/documentation of IVD.

thanks. 

Hello Anon,

As you are asking about Technical File/Documentation, assuming you are meaning Europe and the EU IVDR 2017/746.  I would recommend reviewing the applicable Articles and specifically Annex XIII which speak about clinical performance studies.  The simple answer to your questions are yes.  You can use clinical trial protocols and results for performance of IVD - in fact, if a novel IVD, it is probably required under Performance Evaluation requirements of EU IVDR.  An electronical Trial Master File (eTMF) can also be used, though in my experience this is not really audited by Notified Bodies.  A Performance Evaluation file would be submitted with the application for CE Mark of an IVD medical device under the EU IVDR which would be reviewed.  Then if there is any further detailed review, this may look at the actual clinical data and information contained in the eTMF.  Though probably not too likely.  If you are speaking about a different regulatory region, the information presented concerning clinical trials is usually different.

Hi Community,

I would appreciate your help and thoughts on this.

Can we use clinical trial protocol, results and reports to support clinical performance of IVD, novel IVD?

 is it obligation to have clinical trail study managed under eTMF? is eTMF auditable? i.e., should we expect notified body to audit this?

i am trying to understand how clinical trail can be used within technical file/documentation of IVD.

thanks.