{"id":4162,"date":"2026-08-03T11:12:55","date_gmt":"2026-08-03T09:12:55","guid":{"rendered":"https:\/\/www.cqssalud.com\/eudamed-the-european-database-that-aims-to-bring-order-to-the-landscape-of-medical-devices\/"},"modified":"2026-08-03T11:22:23","modified_gmt":"2026-08-03T09:22:23","slug":"eudamed-the-european-database-that-aims-to-bring-order-to-the-landscape-of-medical-devices","status":"publish","type":"post","link":"https:\/\/www.cqssalud.com\/en\/eudamed-the-european-database-that-aims-to-bring-order-to-the-landscape-of-medical-devices\/","title":{"rendered":"EUDAMED: the European database that aims to bring order to the landscape of medical devices"},"content":{"rendered":"

In healthcare, there is a great deal of infrastructure that goes unseen. It is not found in the doctor\u2019s surgery, does not appear in diagnostic tests, and rarely reaches the patient by name. Yet it has a significant impact on what happens before a medical device is used in a hospital, a laboratory or a health centre. <\/span><\/p>\n

EUDAMED is one of them. <\/span>EUDAMED<\/b> is the European Database on Medical Devices, a computerised system created by the European Union to centralise and manage information relating to medical devices and in vitro diagnostic medical devices <\/span>in vitro<\/span><\/i>marketed in Europe. It brings together data on manufacturers and other economic operators, devices, UDI identifiers, notified bodies, certificates, market surveillance and control, with the aim of improving traceability, transparency, patient safety and coordination between Member States. (<\/span>health.ec.europa.eu<\/span><\/a>)<\/span><\/p>\n

 <\/p>\n

The European database for medical devices is set to enter a significant phase in 2026. In November 2025, the European Commission published the decision declaring the first four modules of the system to be operational, and their mandatory use begins on 28 May 2026. This is no minor change for manufacturers, importers, authorised representatives, notified bodies and competent authorities. <\/span><\/p>\n

In other words, Europe wants a clearer picture of which medical devices and in vitro diagnostic products are on the market, who manufactures them, how they are identified, what certificates they hold and how they are monitored.<\/span><\/p>\n

It may sound like a bureaucratic matter, but there\u2019s a lot more to it than that.<\/span><\/p>\n

Medical devices form part of everyday clinical practice. These range from implantable devices to diagnostic equipment, healthcare software, in vitro tests and devices used in medical procedures. In a system that is increasingly technology-driven, more connected and more reliant on accurate information, traceability is no longer merely an internal matter for the manufacturer but has become a key aspect of healthcare safety. <\/span><\/p>\n

EUDAMED was established within the framework of the European regulations on medical devices and in vitro diagnostic medical devices, known as the MDR and IVDR. Its aim is to bring together on a single platform information that, until now, may have been scattered across different countries, registers, certificates and economic operators. <\/span><\/p>\n

The database is organised into six modules, which are: <\/span><\/p>\n