Implementing Act on Notified Bodies requirements: a pragmatic first step to restore predictability

Posted on 05.03.2026

Short-term measures are needed to stabilise the way in which Europe regulates medical technologies. It is critical to ensure that medical technologies can reach patients in a timely manner. Companies also need to know how to plan in their resources and how long they need until they can get certified and deliver medical technologies to health systems. Diverging practices across the EU have reduced predictability and complicated planning for manufacturers and notified bodies.

The European Commission is developing a new implementing regulation to set out predictable timelines and transparent costs for the assessment activities done by conformity assessment bodies (notified bodies) to certify the quality systems and products of medical technology manufacturers. The aim should be clearer timelines, structured stop-the-clock mechanisms and enhanced transparency on process indicators and fees. These kinds of measures could significantly strengthen the predictability and efficiency of Europe’s regulatory system.

Predictable certification timelines and fees directly support timely patient access and continuity of supply. These also are a bedrock for responsible investment decisions, particularly for small and medium-sized enterprises that rely on regulatory reliability to plan development and allocate resources. In a competitive global environment, dependable regulatory pathways are essential to sustaining Europe’s innovation capacity and industrial base.

The industry has reviewed the draft provisions of the implementing regulation and overall considers them as practical and workable. Adoption in early 2026 would send a clear signal of stability and responsiveness.