Urgent Action Needed To Address Deficiencies In EU's IVD Regulation

Urgent Action Needed To Address Deficiencies In EU's IVD Regulation – As Well As MDR

So far, calls for much needed changes to the medtech regulatory system have focused on the Medical Device Regulation. Don’t neglect the IVD Regulation, industry says.

Status quo versus change — • Source: Alamy

The European medical technology industry is calling on the incoming European Health Commissioner, Olivér Várhelyi, to prioritize the regulation of diagnostic technologies as a crucial component of the overall healthcare system and not just to focus on the regulation of medical devices that come up the scope of the Medical Device Regulation (MDR).

In a joint statement responding to the priorities for medtech regulation outlined in the mission letter from Ursula von...