New EU database to boost patient safety

The Eudamed database for medical devices has been approved by the European Commission and will be in use in all Member States by May next year. The scope of medical devices covered by the database include COCIR member devices like x-ray machines and scanners as well as covering single use products like syringes or blood tests.


The database will mean that safety data like conformity certificates or data on clinical investigations which are now only collected at national level will be put together for the first time across the EU. The European Commission says that the Eudamed databank is "a secure IT tool which will ensure rapid access to such data by market surveillance authorities" with Health Commissioner Dalli saying that the database is "good news for patients across the EU. It will lead to increased patients' safety thanks to rapid access to critical data by national authorities."


More information is available from the European Commission at http://ec.europa.eu/enterprise/sectors/medical-devices/market-surveillance-vigilance/eudamed/.