MHRA Unannounced Audits Frequency Changed?

[BMarch]

Hi There!
I am so glad this forum is back, I have learned so much from the posts.
Can anyone help me with a rumour I have heard that the MHRA has declared that the frequency of unannounced audits changed to 5 years instead of 3 years.
I cant find confirmation of the. Can anyone verify that?

Thanks, Barbara

 

[Pads38]

Welcome to the forums Barbara.

This does seem to be the case - although 'official' statements of facts have been difficult to find. Probably the best so far is the BSi America site here:

https://www.bsigroup.com/en-US/medical-devices/our-services/Unannounced-audits-from-BSI/

There was discussion on this here:

Medical Device Notified Body Surprise Audits Required in 2014

 

[BMarch]

Brilliant, thank you very much. Yes I had great difficulty finding an official statement on this. I began to think it might be hearsay and wishful thinking. Thank you very much for your speedy reply.