The EU's unified regulatory system is EUDAMED. Since EUDAMED is still under development and improvement, manufacturers currently still need to register and complete the registration filing with the regulatory authorities in each EU member state where they have chosen an EU agent. High-risk products require review by a Notified Body (NB) before registration with the regulatory authorities of an EU member state.

EU medical device regulations apply to all EU member states. According to the EU Medical Device Regulation (IVD) classification, the current standard for IVD products is IVDR (EU) 2017/746. According to EU regulations, product classifications are as follows:

IVDR: Class A / Class B / Class C / Class D

Eustar Medical provides IVDR CE certification, IVDR CE technical document preparation, EU agent services, etc. Welcome to inquire and cooperate. Contact email: info@eu-star.email.