The EU's unified supervision system is EUDAMED. Since EUDAMED is still under development and improvement, manufacturers still need to register with each regulatory authority in the EU member state where they choose EUDA and complete the registration filing. High-risk products need to be registered with the regulatory authorities of EU member states after passing the Notified Body (NB) review.

The EU's medical device regulatory regulations apply to all EU member states. According to the classification of EU medical device regulations, IVDR (EU) 2017/746 is currently used for IVD products. According to EU regulations, product classifications are as follows:

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

Eu-star Medical provides IVDR CE certification, IVDR CE technical document preparation, European agency and other services. Welcome to consult and cooperate, contact email: info@eu-star.email.