Accessing Medical Device Adverse Event databases in EU

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A

Aaria

Involved In Discussions
#1
#1
Is there any means to access adverse events database in EU? Basically, in EU, what is comparable to MAUDE database (US)?

Thanks,
Pooja
 
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SteveK

SteveK

Trusted Information Resource
#2
#2
Re: Accessing the Adverse Event database in EU

Hi Pooja,

This is an update of a post I did some time ago giving links to all the regulatory bodies around the world (including EU states) that I could find that supplied alerts etc.

Dead-Links.jpg


In a number of cases you will have to make a few more steps until you get to the medical device or medicines stuff.

Steve

EDIT: Most of the links are now dead. Too many to try to find current links to.
 
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S

Sombra do Vento

#3
#3
To complement Steve's post, I leave you also the link for alerts from the Portuguese Competent Authority (INFARMED):

www .infarmed .pt/ portal/ page/portal/ INFARMED/MAIS_ALERTAS - DEAD LINK REMOVED.

Anything I can help with regard to my country, feel at ease.

Regards.
 
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F

FoGia

Involved In Discussions
#4
#4
I'm reviving this thread for the benefit of many forum users. In general I find the design of websites supposed to inform the public on reported adverse events/recalls horrendous. Hopefully we will see some progress in the future but at the moment collecting data about a specific device/ gorup of devices remains a very very difficult task.
Here is an additionnal link regarding the TGA doing already a better job:
Safety information & education
 
M

Marcelo

Inactive Registered Visitor
#5
#5
There's nothing compared in the EU level, because right now this is done in a national basis. You have to go into each country regulatory body and verify if they have a database. In the future, EUDAMED will have all information at the Eu level.

Aaria said:
Is there any means to access adverse events database in EU? Basically, in EU, what is comparable to MAUDE database (US)?

Thanks,
Pooja
Click to expand...
 
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dgrainger

dgrainger

Trusted Information Resource
#6
#6
There is no European equivalent to the MAUDE database as confidentiality is enshrined into the directives.
Competent authorities can and do publish relevant Field Safety Notices.
 
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