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#77661 25/01/24 4:45 PM
Joined: Sep 2017
Posts: 111
Likes: 3
Savant
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Savant
Joined: Sep 2017
Posts: 111
Likes: 3
Hi,

I just spotted this is new on the MHRA website.

https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-device

There's more info about applications for research new devices.

BW Ian

Last edited by Ian Chell; 25/01/24 4:45 PM.
Joined: Feb 2007
Posts: 289
Likes: 14
Master
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Master
Joined: Feb 2007
Posts: 289
Likes: 14
Are you sure you added the correct link? That page has been around since 2014 and is accosted with clinical investigation as part of the process to obtain a UKCA / CE / CE UKNI mark.

Interestingly I found multiple errors in the electrical guidance for clinical investigations! I need to find the person responsible at the MHRA to inform them of the issues.


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