CE-Marking and EU Registration Flashcards
1
Q
What is the objective of this SOP?
A
To provide instructions for CE-Marking under the 98/79/EC In-Vitro Diagnostic Directive (IVDD) and registering Bio-Rad QSD products for distribution in the EU.
2
Q
What products are excluded from this SOP?
A
Products CE Marked under the IVDR 2017/745, non-medical devices, and products where Bio-Rad is not the “Legal Manufacturer”.
3
Q
A
