What Is A Notified Body?

Planning to develop or market medical devices in the European Union? It's important to understand the role of Notified Bodies, independent organizations that any and all developers should be aware of should they choose to develop or market medical devices in the EU.

Proxima's Director of Regulatory Affairs and Quality Assurance, Ellie Reynolds, explains the significance of Notified Bodies and their role in the EU medical device approval process.

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What You'll Learn:

✅ What Notified Bodies are and their designation

✅ The conformity assessment process

✅ How Notified Bodies evaluate medical devices

✅ CE certification and the CE mark explained

✅ Why expert guidance matters for regulatory compliance

Notified Bodies assess everything from design and manufacturing processes to quality systems and technical documentation to ensure your medical device meets EU regulations and directives.

Working with an experienced CRO can help ensure your product meets all regulatory requirements before a Notified Body audit, saving time and resources in your path to market.

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📧 Questions about EU regulatory compliance? Get in touch with our regulatory experts.

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