Process Validation Before Commencement of Clinical (Investigation) Trials

[JohnC]

I have been unable to find a definitive answer to my question; "Are validated materials required for MDR clinical trials, or will verified material be accepted if there will be no change between verification and validation"?

This is to reduce the time required (by 4 months) to start our clinical trials, the materials would be fully validated before the clinical trials were completed.

I am asking this as ISO 13485:2016 7.5.6 'Validation of processes for production and service provision' states; 'The organisation shall validate any processes for production and service provision where the resulting output cannot be or is not verified by subsequent monitoring or measurement and as a consequence deficiencies become apparent only after the product is in use or the service has been delivered'.

I have been informed that so long as the device has not been commercialised (and covered in our Risk Assessment) then it will be ok, but I just need to make sure as I do not want the Regulator to reject our Clinical Trial notification application, and then have to procure new materials once the processes have been validated.

Any advice will really be appreciated.

John

 

[dgrainger]

There is no such requirement in EU MDR. You have to meet the aspects laid out in Article 62.4 and the CA will assess the application as per Article 71.

If you can, ask the CA directly.