What is the IVDR

There has been an EU Directive (98/79/EC) regulating in vitro diagnostic medical devices (IVDs) since 1993. However, problems emerged with the interpretation and application of that Directive, particularly that it provided only low levels of scrutiny for potentially ‘high risk’ devices.

Developments in life sciences and digital technologies have created opportunities for new IVDs, including increased use of algorithms. Reform was greatly needed to protect patient safety and to properly regulate novel products, as highlighted by the Poly Implant Prothèse defective breast implant scandal. So, how does the new EU Regulation for In Vitro Diagnostic Medical Devices (2017/746), seek to protect and encourage IVD innovation reflecting these dynamic scientific changes, whilst ensuring sufficient regulation of such IVDs to give public and patient protection?

The IVDR came into force on 26 May 2017 and has a 5-year period of transition. This ensures sufficient time for manufacturers and developers to utilise new pathways to market and for suppliers to adapt existing IVDs to comply with new requirements.

Quality, safety and reliability of IVDs will be improved by the IVDR.

The IVDR gives new definitions of what an IVD is and seeks to improve how IVDs are classified, kept under surveillance and regulated. For the first-time, algorithms satisfying these definitions will be regulated as IVDs.