M
Hello All,
I was just wondering if any one else out there has been experiencing delays with MHRA reviews?
We submitted a Class III design dossier for a drug / device combination into the MHRA for review last June, we got a request for further information in July and sent back the response with the required information within 4 days of the request but since then we have heard nothing. At this stage it's well over the maximum 210 days assessment time stated in the Medical Device Directive. I was wondering if anyone else has been having a similar experience? The ancillary medicinal substance in question is chlorhexidine gluconate so it's pretty run of the mill.
Thanks!Masey
I was just wondering if any one else out there has been experiencing delays with MHRA reviews?
We submitted a Class III design dossier for a drug / device combination into the MHRA for review last June, we got a request for further information in July and sent back the response with the required information within 4 days of the request but since then we have heard nothing. At this stage it's well over the maximum 210 days assessment time stated in the Medical Device Directive. I was wondering if anyone else has been having a similar experience? The ancillary medicinal substance in question is chlorhexidine gluconate so it's pretty run of the mill.
Thanks!Masey