Importers in Bulgaria
Look up medical device manufacturers, authorised representatives, importers, and system producers registered across the EU.
An importer places a non-EU manufacturer’s medical device on the EU market.
127 Importers in Bulgaria registered in EUDAMED
Role and obligations in EUDAMED
An importer is the EU-based entity that places a device from a manufacturer established outside the EU on the EU market, and must verify that the manufacturer has met its obligations (MDR 2017/745, Article 13).
Medical device companies in Bulgaria
Top locations in Bulgaria: Sofia, Plovdiv, Varna, Sandanski, Bourgas.
Frequently asked questions
What is a medical device importer?
An importer places a device made by a non-EU manufacturer on the EU market and verifies that the manufacturer has met its regulatory obligations (MDR 2017/745, Article 13).
Do importers register in EUDAMED?
Yes. Importers register as economic operators in EUDAMED and are linked to the devices they import.
How is an importer different from an authorised representative?
An importer makes a device available on the market, while an authorised representative carries the manufacturer’s legal regulatory tasks within the EEA.