Module 14 2022

22/03/2022

Content of the STED

The level of information will depend on the Device High • A new Class III Device with supporting clinical studies

What about • A Class I Device for a well established use that would be Self Certified?

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

9

Content of the STED

Need to address all aspects: • Is it an active device? • Are the effects transient or long term? • Is it implantable? • Is it sterile?

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

10

5