An improved regulatory framework: what do Europe’s diagnostics need?

In vitro diagnostics (IVDs) are essential to modern healthcare, guiding clinical decisions from routine testing to advanced diagnostics. As demand continues to grow, it is crucial that the regulatory framework reflects how these technologies work in practice.​

The European Commission’s IVDR revision proposal is a positive step towards a more efficient and future-ready system. Building on this, a more risk-proportionate approach can further strengthen innovation, support SMEs, and ensure continued access to both essential and specialised diagnostics.​ By aligning regulation with the nature of IVDs, Europe can reinforce a strong, competitive diagnostics sector while ensuring patients benefit from timely access to high-quality tests.

MedTech Europe published its new paper, “An Improved Regulatory Framework: What Do Europe’s Diagnostics Need?”, setting out recommendations to help ensure that the regulatory framework continues to support patient access to innovative diagnostic technologies. The paper complements MedTech Europe’s broader position on the revision of MDR/IVDR and focuses on the specific characteristics of the diagnostics sector.​

Read our IVD-specific paper below.​