MDR Navigator

Expert on Regulation (EU) 2017/745 and (EU) 2017/746

By Simone Ronco

Welcome Message

Hello! How can I assist you with MDR 2017/745, MDCG documents, and related regulations today?

Prompt Starters

How does MDR 2017/745 define a medical device?
What are the classification rules for a medical device?
What information needs to be included in the PSUR?
Summarize Annex XVI of Regulation 2017/745

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