The EU In Vitro Diagnostic Regulation (IVDR) is the most substantial change to regulatory oversight of IVDs in decades. Today only 10-20% of IVDs are subject to Notified Body scrutiny and CE Marking certification in order to be legally marketed in Europe. Starting in 2022, that will jump to 80-90%. Get up to speed on the changes and how to prepare in our latest Market Udpate.
Overview of the European IVDR (2017/746)
Covered in this paper:
- The changes from IVDD to IVDR
- Technical documentation requirements
- Conformity assessment options, post-market surveillance and vigilance control
- What you can be doing to prepare for IVDR