Commission's Go-Live Date For New Eudamed Medical Device Database: Will It Actually Be Met?

 
• By Amanda Maxwell

Many questions surrounding compliance with the data submission requirements under the new Eudamed database remain outstanding. How should companies plan their submissions in the face of these uncertainties? And will the database even be ready on time, or will it be subject to a delay of up to six months?

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There is hopeful news for the EU medical technology sector in terms of preparing for timely compliance with the database elements of the new EU medical device regulations. There have been repeated messages over the last few weeks that the go-live target date for the new version of Eudamed, the European medical device database, is March 26, 2020 – two months before the date of the full application of the new Medical Devices Regulation (MDR), and very much in line with what was being promised a couple of years ago. But there is also a degree of skepticism over whether this will actually happen on time.

Manufacturers all need to be alive to the database's development requirements. As delegates heard at the Association of British HealthTech...

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