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.
IVDs have traditionally 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 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