Accessing Medical Device Adverse Event databases in EU

A

Aaria

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

Thanks,
Pooja
 
Elsmar Forum Sponsor
S

SteveK

#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.
 
Last edited by a moderator:
S

Sombra do Vento

#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.
 
Last edited by a moderator:

FoGia

Involved In Discussions
#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
 

Marcelo

Inactive Registered Visitor
#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.

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

Thanks,
Pooja
 
Last edited by a moderator:

dgrainger

Trusted Information Resource
#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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