1
/
of
1
In Vitro Diagnostics 2017/746 Medical Devices
In Vitro Diagnostics 2017/746 Medical Devices
SKU:978-1-935131-38-0
Regular price
$11.95
Regular price
Sale price
$11.95
Shipping calculated at checkout.
Quantity
Couldn't load pickup availability
Regulation 2017/746 of the European Parliament on in vitro diagnostic medical devices.
The Regulation shall apply to in vitro diagnostic medical devices and their accessories.
The changes under Europe’s new IVD regulation are significant, including the need for Notified Body involvement, a greatly expanded definition of what is considered an IVDR, a new risk-based IVD classification system, increased clinical evidence requirements, new quality system mandates, and more rigorous postmarket scrutiny.
Share
