The new Estonian Medical Devices and Appliances Database (EMDDB) is now available to users, replacing the previous system, which had been in use for more than ten years.
The update aims to simplify the submission and management of data and improve the collection, management and publication of information on medical devices and appliances. The new system also improves data quality, transparency and usability for both companies and authorities.
What is different in the new database?
The development of the new EMDDB took into account user feedback, known shortcomings of the previous database, as well as the needs of the State Agency of Medicines and the Estonian Health Insurance Fund. The main updates include:
• Updating existing entries is significantly simpler, with changes to device data and documentation now able to be submitted in a single notification;
• Linking a new distributor to an existing device entry is processed automatically if no other changes are made;
• The user interface has been modernised, with clearer and more user-friendly workflows;
• Most data is based on information available in the European Database on Medical Devices (EUDAMED), reducing the administrative burden on companies.
Greater transparency
One of the most significant changes is greater openness and transparency. While several documents demonstrating compliance were previously visible only to the State Agency of Medicines, the following documents are now publicly available:
• EU declarations of conformity;
• Certificates;
• Statements for systems and procedure packs.
Making these documents publicly available improves access to important information for market operators, healthcare professionals and patients, while increasing overall transparency.
The mandatory use of the European Database on Medical Devices (EUDAMED), together with its integration with the EMDDB, helps ensure that information on medical devices available in Estonia is up to date and of high quality.
The database also supports the market surveillance activities of the State Agency of Medicines and continues to enable companies to apply for the inclusion of devices in the list of medical devices reimbursed by the Estonian Health Insurance Fund.
The authorities have welcomed continued feedback from users to support further development of the database.
