EU Medical Device Manufacturer Warning Letters

9

95101221

#1
Hi,
I have went around the MHRA website for a while trying to find a e-reading room similar to the US FDA's for warning letters regarding contact lens manufacturers in the UK market.
is there any online resource/database for warning letters issued to medical device manufacturers?
please help.
 
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Pads38

Trusted Information Resource
#2
Re: EU medical device manufacturers warning letters

Hi,
is there any online resource/database for warning letters issued to medical device manufacturers?
please help.
Not that I am aware of - however -

Contact lens manufacturers would mostly interact, not with MHRA, but with their Notified Body and those communications would not be publicly available (perhaps they should?).

What MHRA does have is archives of Recalls and Field Safety Notices, although they are stored as collections of "FSNs for month / year" which doesn't make searching very easy.

What you may try is using Google to do a site search on MHRA

eg

google " acme contact lens site:www.mhra.gov.uk "

It would probably work if your search term is fairly specific - searching for, say, 'contact lens' would probably swamp you with results.
 

pkost

Trusted Information Resource
#3
Re: EU medical device manufacturers warning letters

To expand on Pads38 comment slightly. Article 20 of the directive on confidentiality is quite restrictive on the type of information that can be released. You will not find any equivalent to warning letters in the EU (with the exception warnings that directly alert to the safety of a device in the market)
 
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