Where to find medical device vigilance data in Europe while Eudamed is not fully functional? Check out these 16 European databases (Update 2024)

This is an update of a 2022 blog post. Not much has changed with Eudamed since then. It’s still not fully functional. Those looking for medical device vigilance data in Europe, need to continue looking elsewhere.

What also hasn’t changed, fortunately, is that some EU member states and a few other European countries continue to provide country-specific medical device vigilance databases.

The 2022 blog post covered 5 databases. This post will cover more, thanks to the feedback on the original post and the research done on my own.

So, let’s check out 16 European databases where you can find medical device vigilance data in Europe right now.


What are the medical device vigilance databases in Europe?

The country-specific databases are listed in a table below.

The post continues after the table.

Austria

Access BASG database here.

How to use the database: You can search for safety warnings by entering a keyword, checking ‘Medical Devices’ from the Category list and/or selecting a time period.

Usability review: The market surveillance pages are available both in German and in English. The search options are limited to keyword, category and time period. Only 8 medical device safety warnings have been listed since 2006. As a reader I can’t help but wonder how often the warnings list is updated or is the Austrian market just super safe. The safety warnings often include attachments which can be downloaded.

Czechia

Access RZPRO database here.

How to use the database: You can look for field safety notices (FSNs) by typing in medical device name and/or manufacturer name, and/or selecting publishing dates.

Usability review: The page is accessible both in the Czech language and in English. The search options enable to focus on the manufacturer, device and/or publishing dates. The search results are given in a clear table format. Attached FSNs can be downloaded, typically both in the Czech language and in English.

Denmark

Access Lægemiddelstyrelsen database here.

How to use the database: You can hunt for safety notices from medical device manufacturers by selecting a product type, recall reason, safety message type and/or year, and/or typing in a keyword.

Usability review: The page is available in Danish. With a browser translation extension, you can get the page translated into English. There’s quite a lot to choose from in the search options. The search results usually contain downloadable FSNs, which might be both in Danish and in English.

Estonia

Access Terviseamet database here.

How to use the database: FSNs can be accessed by selecting a year.

Usability review: The page is accessible in Estonian. With a browser translation extension, you can get the page translated into English. The only search option is to filter the FSNs by year. Here the ‘year’ doesn’t seem to be referring to the year when the FSN was published by the manufacturer. For example, when you open some of the January 2024 FSNs, you can see 2023 as the manufacturer’s publishing date. In addition to the yearly groupings of the FSNs, there are monthly groups. You need to scroll the page to locate them. The listed FSNs can be downloaded.

France

Access ANSM database here.

How to use the database: You can search for product recalls, quality defects, and safety info for users by entering a keyword and/or selecting a medical field and/or health product type.

Usability review: The page is available in French. With a browser translation extension, you can get the page translated into English. There’s a variety of search options, and you can also filter search results by a reference document type and publication date. Attached FSNs can be downloaded.

Germany

Access BfArM database here.

How to use the database: You can look for the FSNs by first selecting ‘find all corrective actions’. Then select category, product group, format and/or period, and/or enter keyword in the search field.

Usability review: The content is available both in German and in English. There’s a variety of search options, and also an option to sort the search results by relevance, latest entries first or oldest entries first. You can download the FSNs in the language which you’ve selected.

Greece

Access EOF database here.

How to use the database: You can select the number of items displayed per page and scroll the pages to look for information on medical devices which EOF has identified as non-compliant and for which it has issued a press release.

Usability review: The page is accessible in Greek. With a browser translation extension, you can get the page translated into English. There’s no search option.

Ireland

Access HPRA database here.

How to use the database: You can search for FSNs by filtering the FSN list by type of safety notice, and/or date or title of safety notice.

Usability review: The page is available in English. The search functionality is more of a sorting than searching option. You cannot search for example by a device or manufacturer name. The FSNs are downloadable.

Italy

Access Ministry of Health Directorate General of Medical Devices and Pharmaceutical Services database here.

How to use the database: FSNs can be searched by typing in manufacturer and/or device name, and/or selecting device type and/or year of publication.

Usability review: The page is available in Italian. With a browser translation extension, you can get the page translated into English. There are several search options to choose from. The FSNs can be downloaded.

Netherlands

Access IGJ database here.

How to use the database: To look for FSNs, type in a keyword, and/or select a period, subject, element and/or type.

Usability review: The page is available in Dutch. With a browser translation extension, you can get the page translated into English. The search options are versatile, and you can sort the search results by date or relevance. The FSNs are downloadable.

Poland

Access URPL database here.

How to use the database: FSNs can be searched by scrolling the list of safety messages or the archives.

Usability review: The page is available in Polish. With a browser translation extension, you can get the page translated into English. There is no search functionality. The FSNs are downloadable.

Portugal

Access Infarmed database here.

How to use the database: You can search for safety and quality alerts from the past year by scrolling the list of alerts.

Usability review: The page is available in Portuguese. With a browser translation extension, you can get the page translated into English. There are no search options. Only the list of alerts from the past year can be scrolled. You can download the information bulletins attached to the alerts.

Spain

Access AEMPS database here.

How to use the database: You can look for AEMPS information notes by selecting a year.

Usability review: The page is available in Spanish. With a browser translation extension, you can get the page translated into English. No search functionality exists. You can either scroll the list of notes or select a year. The information notes are not limited to safety messages, but may range to AEMS info bulletins too. The files attached to the notes, e.g. FSNs, can be downloaded.

Sweden

Access Läkemedelsverket database here.

How to use the database: To search for safety news, enter a keyword, and/or select medical devices, safety news from Läkemedelsverket, safety news from manufacturer, and/or publication date.

Usability review: The page is available in Swedish. With a browser translation extension, you can get the page translated into English. You can make use of a few search and sorting options (relevance, date and title). The FSNs are downloadable.

Switzerland

Access Swissmedic database here.

How to use the database: You can look up FSNs by typing in a keyword, and/or selecting a publication date.

Usability review: The page is available in English, German, French and Italian. In addition to search functionality, you can sort the results by publication date or reference, select either a descending or ascending direction and narrow down the search to updates only. The search results can be exported, and the link of the current search can be copied and shared. You can download the FSNs, which may be available in 1-4 languages depending on the case.

UK

Access MHRA database here.

How to use the database: Enter keyword, and/or select message type, medical specialty and/or issued to search for FSNs, national patient safety alerts, device safety information and/or medicine recalls.

Usability review: The page is available in English. The search functionality is limited. You can download documents attached to the safety communication, such as the FSNs.


Despite Eudamed delays, you can still search for and find medical device vigilance data in Europe. Just take advantage of the country-specific databases!

Have you used any of the databases listed above? If you have, please let me know in the comments. I’m interested to read about your experiences.

And if you have any questions or concerns about Eudamed, vigilance data or anything else in the MDR scope, you’re welcome to send me a message.

I’m always happy to listen to what’s on your mind and help you take the next step.

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2 kommenttia artikkeliin ”Where to find medical device vigilance data in Europe while Eudamed is not fully functional? Check out these 16 European databases (Update 2024)”

  1. Hi Tiina,
    Thank you for making this very useful blog. I know everyone is excited for EUDMAED to be released and functional, but do you happen to know why competent authorities in EUROPE hasn’t made their FSN’s and recalls more accessible and searchable akin to the US effort more than a decade ago? I am really curious to know what are your thoughts? Is this just a matter of not investing in IT resources? It seems to be a bit strange that not a single one of them have something searchable as easy as the FDA database.
    many thanks
    Ranj

    Vastaa
    • Hi Ranj, happy to hear you’ve found the blog useful. Eudamed is definitely intended to close the gap in having a centralised medical device vigilance database in the Union market. As to why there hasn’t been anything like Eudamed before, I think it comes down to different regulatory frameworks, and the national interests and varying resources of each Union member state.

      Now that you brought up the FDA database, I’m curious to hear what you see as its pros and cons. In your opinion, what can FDA Maude teach Eudamed?

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