MHRA (Medical & Healthcare Regulatory Agency) Design Dossier Review Delays

M

Masey B

#1
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:)
 
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D

deuce64

#2
Re: MHRA Design Dossier Review Delays

Not specific to this, i think MHRA is getting really tough. They have alot going on with the PIP issue and Metal Hip stuff that was recently posted. I'd expect this now going forward.
 
M

Masey B

#3
Re: MHRA Design Dossier Review Delays

Thanks deuce64, makes sense why they would be so cautious going forward. The fun part for me is trying to explain regulatory red tape to the powers that be on our board :)
 
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