Can I read IVD Regulation Overview and Changes on EtoBox?
IVD Regulation Overview and Changes by rajiveacharya is a document available to read on EtoBox.
What is IVD Regulation Overview and Changes about?
The new EU IVD Regulation expands the scope of regulated in vitro diagnostic devices in several key ways compared to the previous Directive. It will cover more product types like laboratory developed tests, genetic tests, and test services involving distant sales and internet sales. The Regulation also establishes new categories of point-of-care and companion diagnostic devices. Overall, the changes aim to strengthen oversight of manufacturers and ensure better traceability and control of medical devices in
- Author
- rajiveacharya
- Language
- EN