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Need to create or update your medical device’s risk profile?
Or establish a watertight state-of-the-art in the device’s clinical evaluation?
If so, you need vigilance data on your medical device, equivalent device (if used) or the competitors’ devices on the European market.
But where to find the precious data?
Your company has probably kept records of your device, so you think you should be fine.
But are you?
Under the MDR, the notified bodies have become pickier. They want to see that you understand your device’s (and equivalent and competitors’ devices) risks on the market. They’re looking for you to take proactive measures and find evidence from the field too.
With Eudamed’s full launch expected to take until spring-summer 2024, adverse event data seekers need to look elsewhere for a solution.
Luckily some EU member states and a few other European countries provide country-specific vigilance databanks to the public.
Without further ado, let’s check out 5 European databases where you can find medical device vigilance data in Europe right now.
1. HPRA
The Irish competent authority HPRA provides three types of safety notices/communications on their website: Safety Notices, Information Notices and Manufacturer Field Safety Notices (FSNs).
They are said to be used to communicate trends or emerging issues to healthcare professionals and/or users of medical devices, and to share health issue information relevant to the Irish market or Irish customers in case there is reason to believe they may not be aware of the safety issues in question.
If you have a specific time period or a safety issue type in mind (e.g. recall, warning), then you might find what you’re looking for quite easily. Unfortunately you cannot search by a keyword or a brand name, and the filtering features are quite limited too. The monthly summaries of Field Safety Notices are a nice touch.
2. ANSM
The French competent authority ANSM’s site may look a bit daunting at first to non-native French speakers. By using a translator feature on your browser (such as Google Translate), voilà, the site becomes more understandable.
The search functionality is very clear. You can search by entering keywords, checking a medical domain (domaine médical) or health product (produit de santé) box. Once the results are displayed, you can continue the search by checking reference document type boxes (documents de référence) and defining the adverse event reporting time. The search results will return for example product recalls, quality defects and safety info for users. You can review and download their attachments, which are typically in French though.
The database is a bit slow especially if you’re using the translator feature. I recommend using the page in French (it’s very intuitive) for at least part of your search journey.
3. BfArM
You can find device corrective actions, including recalls, on the German market from the Field Corrective Actions database on German competent authority BfArM’s website. And it’s all in English too.
By clicking on ”find all field corrective actions”, you can set search parameters such as product group, format of communication and time period. There’s a possibility to review and download the FSNs you find.
And if you’re interested in BfArM’s recommendations based on their evaluations of the incident reports they’ve received, they share them here.
4. Swissmedic
The Swiss Agency for Therapeutic Products hosts an impressive medical device vigilance database. It comes with four language versions (English, Italian, French and German). You can export the search results of FSCAs and recalls made on the Swiss market and share the search results via links. The FSNs you find can be reviewed and downloaded.
5. MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has a database with alerts, recalls and safety information. You can search with keywords and set medical speciality, alert type and search timeframe.
There’s no need to let Eudamed full functionality delays stop you from searching for and finding medical device vigilance data in Europe. You just need to look for country-specific sources.
The databases presented above can help you build an evidence-backed risk profile of your device, equivalent device or the competitors’ devices in Europe. That will be valuable in clinical evaluations, risk management and post-market surveillance. Consequently, it can make it easier for you to meet your notified body’s expectations and pass the MDR certification scrutiny.
Have you come across any other databases besides the ones listed above? Please let me know in the comments.
