Articles
Read the latest news and articles from RegMetrics
What is the difference between IVDR Class D and C?
This blog post will discuss ways in which high personal and public health risks for In Vitro Diagnostics (IVD) devices are determined – and introduce some of t…
What is an In vitro Diagnostic Device?
The first step in the regulatory pathway for any organisation is to identify the relevant regulation. Within the medical device industry, the most important di…
What are the new device classifications in the In vitro Diagnostic Regulation (IVDR)?
Following a series of scandals, most notably regarding the Poly Implant Prosthesis (PIP) Breast Implant there was a major overhaul of European medical device r…