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Rob Packard
Ship & Print Your FDA eCopy
February 2017
Where you can find adverse event data for your device
2 min reading time

Most countries have some kind of database for gathering adverse event data for medical devices, but most of these databases are not open to the public. The most common question I am asked is, “How do you access the Eudamed database?” for reporting of adverse events in Europe. Unfortunately, you can’t access Eudamed. The Eudamed database is only available to competent authorities at this time.

The latest update is that manufacturers will be responsible for updating the Eudamed database in the future as part of the new European Regulations. This requirement will be implemented during the next years. The database will also become accessible to the public.

The primary publicly accessible database for adverse event reporting is the US FDA MAUDE database:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm

The MAUDE database is also integrated with other FDA databases for 510k submissions and recalls. This combined database is called the Total Product Life Cycle database:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/tplc.cfm

The Therapeutic Good Administration (TGA) in Australia makes adverse event data publicly available:

http://apps.tga.gov.au/prod/DEVICES/daen-entry.aspx

The TGA also has a national registry for implanted orthopedic devices that publishes an annual report. There are other countries that also have public registries.

Searching for post-market surveillance data should be performed on a frequency that is risk-based. If you have a brand new device, a high risk device or a device that is implanted; post-market surveillance data should be reviewed frequently–either monthly or quarterly. In fact, the new European guidance document for clinical evaluation reports (MEDDEV 2.7/1 rev 4) requires that clinical evaluation reports be updated at least annually for these devices:

http://ec.europa.eu/DocsRoom/documents/17522/attachments/1/translations/en/renditions/native

It is also important that you collect post-market surveillance data for both your device and competitor products. Therefore, you should be reviewing all the publicly available adverse event databases. You should also be reviewing your own complaint data, and you should be searching for journal articles that may include adverse event data–possibly associated with a clinical study.

If you are interested in the full text of this article and future articles, please visit my blog page:

http://www.medicaldeviceacademy.com/blog/

source: https://www.linkedin.com/groups/2070960/2070960-6232439645834084353

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Posted by Rob Packard
Asked on February 1, 2017 8:00 am
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Private answer
Steve Kent As well as the FDA and TGA sites there are also the following resources (a number of which are duplicates from other competent authorities):
https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
http://healthycanadians.gc.ca/recall-alert-rappel-avis/search-recherche/simple/en/?f_mc=3
http://www.mdco.gov.hk/english/safety/safety.html
http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices
http://ncmdr.sfda.gov.sa/Secure/CA/AdvanceSearch.aspx
http://ansm.sante.fr/S-informer/Informations-de-securite-Autres-mesures-de-securite#dm
http://www.bfarm.de/SiteGlobals/Forms/Suche/EN/kundeninfo_Filtersuche_Formular_en.html?nn=4527724&searchEngineQueryString=search+item&gtp=3494768_list%253D2
http://www.salute.gov.it/portale/news/p3_2_1_3.jsp?lingua=italiano&menu=notizie&p=avvisi
http://www.swissmedic.ch/rueckrufe_medizinprodukte/index.html?lang=en
http://www.medsafe.govt.nz/hot/recalls/recallsearch.asp
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Steve Kent There are also these (could not fit in previous comment):
Greece
http://www.eof.gr/web/guest/withdrawalsmedical;jsessionid=fe58efe1052e448d8a6f5f8b6220
Czech Republic
http://www.sukl.eu/medical-devices/field-safety-notices

When you do find problems with Medical Devices similar to your own as alerts, recalls or FSNs then you can use the information to update your Risk Management and/or Clinical Evaluation sections of your Technical File.

As to monitoring competitors, I also have a database of circa 290 companies who produce similar products to ours worldwide which I routinely check and reference some of the closest matches in my Clinical Evaluations.
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Rob Packard Thank you Steve. Great resources!
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Centralized reporting will be implemented during this year together with new Medical Device Regulation. Eudamed is not running yet and vigilance system (incidents reporting and related FSNs and FSCAs...) are being reporting to CAs each country and NBs involved.
Eudamed will we also incorporate centralized product registration, UDI, ...
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Christopher Buck

Thank you for identifying these additional AE databases! Are you aware of any current resources/companies (e.g. software or data miners) that will search all or selected adverse event databases to gather, filter, and report out data for identified similar devices?

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