Point by point, with the main statement first: each individual country in the unified European Union has their own databases or none at all, i.e. United Kingdom, France, Switzerland. Until EUDAMED is fully functional and running, there is no singular location for all of this information you listed.
In Europe there is no equivalency of Warning Letters by any regulatory agency. There are only inspections performed, however, under the EU MDR 2017/745 there will be more ability for Member States Competent Authorities to remove product from being placed on the market. What this will look like, not sure. Maybe it will be a letter to the company's Notified Body resulting in a letter to the company from the Notified Body their EU certificate has been suspended or withdrawn.
You can get potentially get inspections performed by Competent Authorities through some countries request of information - similar to the United States Freedom of Information. This can be a very long process.
No centralised database for recalls - handled by each country. No centralised database for vigilance - serious incident reports. Not very much information publicly available which is handled currently country by country. The current EUDAMED system does have vigilance information such as incident reports and Field Safety Corrective Actions, but this is not public information.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 12-Jul-2019 22:11
From: Anne LeBlanc
Subject: EU Medical Device Database Search
So far, there's not a lot of information made available. And each country does it differently.
But there is some. For example: https://www.gov.uk/drug-device-alerts
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Anne LeBlanc
Manager, Regulatory Affairs
United States
Original Message:
Sent: 12-Jul-2019 15:09
From: Chelsea Becker
Subject: EU Medical Device Database Search
Are there any EU databases that currently exist to search for the following:
- Warning letter equivalents
- Inspection results
- Recalls
- MAUDE- like database
I know EUDAMED is on the horizon, but I was wondering if there are other places that I can search for this information.
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Chelsea Becker JD, RAC
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