Oct 16 • General discussion
Quality Manual Content & Economic Operators
Hey everyone!
I'm excited to share a new document I've put together, focusing on a critical aspect of medical device compliance in Europe: "Quality Manual Content & Economic Operators under MDR (EU) 2017/745."
If you're involved in the medical device industry, you know how complex the EU Medical Device Regulation (MDR) can be. This article dives deep into two key areas:
- What your Quality Manual must contain to meet the stringent requirements of MDR.
- The roles and responsibilities of "Economic Operators" – from manufacturers to importers and distributors – and how they fit into the compliance puzzle.
Understanding these elements is crucial for ensuring your devices can legally be placed on the EU market and remain compliant. I've broken down the intricacies into clear, actionable insights.
Why is this important? Getting your Quality Management System (QMS) right and clearly defining economic operator roles are foundational to avoiding regulatory pitfalls and ensuring patient safety.
I hope you find it valuable for staying ahead in this ever-evolving regulatory landscape!
Cheers, Guillaume Saint-Pierre
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Quality Manual Content & Economic Operators
