What is EUDAMED? EUDAMED is a database used for registering medical device information across Europe. The database serves for transparency and coordination of information. MDCG has published the following guidance for EUDAMED Gradual roll out of EUDAMED Q&A on practical aspects related to the implementation of the gradual roll-out of...
What is MDCG guidance? Documents for EU MDR and IVDR
What is MDCG? The EU Medical Device Coordination Group (MDCG) is responsible for issuing guidance on the application of EU Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR). These documents provide clarity on regulatory compliance for manufacturers and stakeholders in the medical device industry. Medical Device Coordination Group...
