The In Vitro medical devices faced the implementation of the European Community Directive 98/79/EC in 1998. The In Vitro Diagnostic Directive (IVDD) 98/79/EC has been now transformed to In Vitro Diagnostic Regulation (IVDR) 2017/746/EU. The official timeline for this transition phase to complete implementation is 5 years (26th May 2022).
The current regulatory framework for In Vitro diagnostic medical devices has showcased its benefits yet has faced criticism in the recent years. Various drawbacks were recognized in the IVDD: new advances related to genetic testing and companion diagnostic devices that are not especially mentioned in IVDD, the need to have a better alignment with international guideline- inclusive of a risk-based classification system- and the low control over high-risk ‘in-house’ tests.
This revision aims to overcome these flaws and divergences and to further strengthen patient safety.Download