The US Food and Drug Administration’s (FDA’s) Breakthrough Devices Program was established to facilitate earlier patient access to novel medical devices addressing serious health conditions, by offering prioritized review and enhanced communication with regulators. Despite its promise, only a small percentage of devices granted Breakthrough designation have achieved marketing authorization, reflecting persistent regulatory and evidentiary hurdles.
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YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS
At the end of 2025, as part of a bundle of measures to make the EU health sector more innovative, competitive and resilient, the European Commission proposed the EU Biotech Act (the Act) aimed at repositioning the EU as a global biotechnology hub. It includes a wide range of proposals, such as access to funding, streamlined regulatory processes, and increased incentives for innovative products. The proposal signals that the EU institutions are attempting to make the EU a more pro-innovation environment, and many of the proposals will likely be welcomed by industry.
In a pre-Christmas gift, the European Commission has adopted a proposal to simplify Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR): Proposal for a regulation to simplify rules on medical and in vitro diagnostic devices. The key elements of the revisions are summarized in a factsheet and in a questions and answers document.