Blog Article: In-vitro diagnostics regulation: From oversight to overhead -- MEDICA - World Forum for Medicine

11/01/2018

Castor EDC

Blog Article: In-vitro diagnostics regulation: From oversight to overhead

The rising demand for early, accurate disease diagnosis and the growing possibilities in personalised medicine are driving the demand for In-Vitro Diagnostic medical devices (IVDs). Thermometers, blood glucose monitoring devices and pregnancy tests, are an integral part of our lives.

Traditionally IVDs have been subject to little regulation when compared to medical devices or pharmaceuticals. The new In-Vitro Diagnostic Regulation (IVDR), however, will constitute a true quantum leap in regulatory burden. This white paper we will focus on the IVDR and how IVD companies can meet these regulatory changes. We will cover:

The regulatory framework
The new scope of IVDs
Changes in classification
New clinical evidence requirements

Download your copy of the White Paper from the link below

Exhibitor Data Sheet