Uuenduste eesmärgiks on lihtsustada andmete esitamist ning selles lähtutakse suuremas osas Euroopa meditsiiniseadmete andmebaasis (EUDAMED) olevatest andmetest. Andmekogu pidamise eesmärgiks on hoida ülevaadet Eestis kättesaadavaks tehtud meditsiini- ja in vitro diagnostikameditsiiniseadmetest, süsteemidest, protseduuripakettidest ja tellimusmeditsiiniseadmetest. Samuti võimaldada ettevõtjatel seadmete lisamist Tervisekassa poolt hüvitatavate meditsiiniseadmete loetellu. Uue andmekogu kasutuselevõtt toetab Ravimiameti tööd meditsiiniseadmete turujärelevalve teostamisel. 

Andmekogu uuendamisel oleme arvesse võtnud teadaolevad kitsaskohad, kasutajate tagasiside ning samuti lähtusime Ravimiameti ning Tervisekassa vajadustest. Parendatakse eelkõige kasutusmugavust nii taotluse esitaja kui ka menetleja vaatest. 

Mõned olulisemad uuendused andmekogus:

• Olemasolevate kannete uuendamine muutub lihtsamaks ning kõiki vajalikke seadme andmeid ja dokumente puudutavaid muudatusi saab teha ühe teatisega. 
• Juba olemasoleva seadme kandega uue levitaja sidumine ilma muudatusi tegemata on edaspidi automaatselt kinnituv.
• Läbipaistvuse suurendamine, kuna seni ainult ametile nähtavad olnud nõuetele vastavust kinnitavad dokumendid - ELi vastavusdeklaratsioonid, sertifikaadid ja süsteemide ja protseduuripakettide kinnitused - muutuvad nüüd avalikuks. 

Olulise muudatusena Eesti tootjatele ja volitatud esindajatele - seoses EUDAMEDi kohustuslikkusega alates 28.05.2026 kaob seni kehtinud teavitamiskohustus, mille kohaselt Eesti tootjad ja volitatud esindajad pidid teavitama meditsiiniseadme turule laskmisest MSA kaudu (loe rohkem siit). Erisus ei kehti tellimusmeditsiiniseadmetele, mida EUDAMEDi ei registreerita ning nende puhul jääb endiselt kehtima meditsiiniseadme seadusest tulenev teavitamiskohustus. 

Jälgige meie andmekogu ja Ravimiameti kodulehe uudiseid – plaanime töötubasid ning avaldame jooksvalt olulist infot, et hoida Teid arengutega kursis ning muuta üleminek uuele andmekogule võimalikult sujuvaks.

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From 1 June 2026, a new version of the Medical Devices and Appliances Database (EMDDB, https://msa.sm.ee/eng) will be introduced. The database is being updated due to European Union medical device regulations and to enhance overall usability. The aim of the new version is to simplify data submission, largely relying on data available in the European database on medical devices (EUDAMED). The purpose of maintaining the database is to provide an overview of medical devices and in vitro diagnostic medical devices, systems, procedure packs and custom-made medical devices made available in Estonia. It also enables companies to apply for the inclusion of devices in the list of medical devices reimbursed by the Estonian Health Insurance Fund. The introduction of the new database supports the State Agency of Medicines in carrying out market surveillance of medical devices.

In updating the database, we have taken into account known shortcomings, user feedback, and the needs of the State Agency of Medicines and the Estonian Health Insurance Fund. Improvements primarily focus on enhancing usability from both the applicant’s and the processor’s perspective.

Some of the key updates to the database include:

• Updating existing entries will become simpler and all necessary changes concerning device data and documentation can be submitted in a single notification.
• Linking a new distributor to an existing device entry without making other changes will be automatically approved.
• Increased transparency: documents confirming compliance that were previously visible only to the authority — such as EU declarations of conformity, certificates, and statements for systems and procedure packs, will now be made public.

As a significant change for Estonian manufacturers and authorised representatives, due to the mandatory use of EUDAMED from 28 May 2026, the current notification obligation will no longer apply. Until then Estonian manufacturers and authorised representatives were required to notify the placing of a medical device on the market via the EMDDB (read more here). This exception does not apply to custom-made devices, which are not registered in EUDAMED. For these, the notification obligation under the Medical Devices Act will continue to apply.

Please follow news updates on our database and on the website of the State Agency of Medicines. We are planning workshops and will regularly publish important information to keep you informed of developments and to ensure as smooth a transition as possible to the new database.