Accessing Medical Device Adverse Event databases in EU

A

Aaria

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

Thanks,
Pooja
 
S

SteveK

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

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
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
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
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.
 

Marc

Fully vaccinated are you?
Leader
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.
Is this still the case?
 
Thread starter Similar threads Forum Replies Date
B Complaint Records - Accessing records on Easy Track Software Records and Data - Quality, Legal and Other Evidence 3
L Getting Notice of Revision and Accessing Public Draft Copies of ISO Standards Service Industry Specific Topics 2
M Accessing Assist.daps AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
M Informational EU – M2M Data Exchange available services for accessing MDR EUDAMED data available for Economic Operator (EO) organisations Medical Device and FDA Regulations and Standards News 0
Sidney Vianna Accessing the Xenforo version of Elsmar via a smartphone Elsmar Xenforo Forum Software Instructions and Help 8
J Accessing and Using Databases via a Tablet Device Quality Assurance and Compliance Software Tools and Solutions 4
S Accessing data from separate worksheets in Minitab Using Minitab Software 3
M If there is any restriction on the transportation of Used Medical Device (with blood) from Canada to other countries? Canada Medical Device Regulations 4
M If there is any restriction on the transportation of Used Medical Device (with blood) from EU to other countries? EU Medical Device Regulations 2
adztesla Sterile packaging validation for medical device - ASTMD4332 and ISTA2A ISO 13485:2016 - Medical Device Quality Management Systems 3
P On-going stability study requirement for medical device US Food and Drug Administration (FDA) 2
K Medical devices for laymen and necesssary reprocessing Other Medical Device Related Standards 3
N Regulations for Medical Device in Jamaica Other US Medical Device Regulations 0
M Classification of device according to China medical device regulations China Medical Device Regulations 4
M Looking for kindly help... If there is any prohibits from contract manufacturing in US? About SR medical devices US Medical Device Regulations 0
adztesla Design change and Process change Class 3 medical device Medical Device and FDA Regulations and Standards News 2
K New set of medical devices - samples EU Medical Device Regulations 3
M Importing a custom component for our medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
FRA 2 FDA Reusable Vs Single Use Medical Devices in EU Other Medical Device and Orthopedic Related Topics 1
adztesla Adding new supplier/ Medical device design change ISO 13485:2016 - Medical Device Quality Management Systems 2
adztesla Medical device Drawing related change justification Other Medical Device Related Standards 0
O Medical Device With 2 Power Cords IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
Stoic Which medical device companies are using Recombinant Factor C (rFC) instead of Limulus Amebocyte Lysate (LAL) for endotoxin testing? Sustainability, Green Initiatives and Ecology 0
I Commercializing a non medical device software Medical Information Technology, Medical Software and Health Informatics 10
I Non-medical device software Preventive Action and Continuous Improvement 1
C California Prop 65 for medical device labels US Medical Device Regulations 3
adztesla GDP rules- redline drawings in medical device Medical Device and FDA Regulations and Standards News 2
R Instructions for Use supplied with Medical Device Components Medical Device and FDA Regulations and Standards News 4
M Deburring plastic medical device Manufacturing and Related Processes 1
W Training software medical device Medical Device Related Standards 0
S Modification of medical device EU Medical Device Regulations 2
I Commercialize a non-medical product ISO 13485:2016 - Medical Device Quality Management Systems 5
P Do Barcode scanners need validation in Medical device manufacturing? Manufacturing and Related Processes 6
F The use of 4G/Wi-Fi dongles in medical devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
B FDA Requirements for medical device to be used for training purposes only US Food and Drug Administration (FDA) 9
L Verification of wireless QoS and coexistence during FDA certification of medical devices Medical Device and FDA Regulations and Standards News 1
F Adding wireless communication to existing medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
J Medical device sizes and system and procedure packs EU Medical Device Regulations 0
U Does Medical Device training video falls under labeling requirement ? Other US Medical Device Regulations 4
dgrainger Informational Consultation: Medical devices – single identifier for similar highly individualised devices EU Medical Device Regulations 0
dgrainger Informational MHRA Guidance: Crafting an intended purpose in the context of Software as a Medical Device (SaMD) UK Medical Device Regulations 0
J Is ISO 13485 certification necessary for Class I (non-sterile) medical devices? ISO 13485:2016 - Medical Device Quality Management Systems 7
L Directive 2012/19/EU for medical software EU Medical Device Regulations 2
S Sample size considerations in medical process qualification Reliability Analysis - Predictions, Testing and Standards 11
B Medical device disposables - Stored in a controlled environment for 4 months - Effects on Sterilization Medical Device and FDA Regulations and Standards News 1
W MOOPs in Medical Device Charger IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
adztesla Specification (Significant digits) - Measurement (Medical device) ISO 13485:2016 - Medical Device Quality Management Systems 3
S Accessory to medical device or not? EU Medical Device Regulations 1
M Looking for medical grade wall adapter with 50Hz power transformer IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
E Microbial Barrier Testing for Medical Devices Qualification and Validation (including 21 CFR Part 11) 2

Similar threads

Top Bottom