MedTech Europe has recently published its new position paper:
“MDR/IVDR Revision: A Regulatory System at a Crossroads – Position & Proposed Amendments”.
The document highlights key challenges currently faced by the medical device industry, including regulatory complexity, capacity constraints, innovation delays, and global competitiveness concerns within the European market.
The publication reflects the ongoing discussion around the future of the European regulatory framework and the need to ensure both patient safety and timely access to innovation.