The EU’s legal landscape increasingly impacts the medical technology industry through both vertical and horizontal legislation. Vertical frameworks namely, the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR), are tailored specifically to the sector to ensure safety and performance of medical technologies. In contrast, horizontal regulations encompass broader, cross-sectoral rules that also require compliance, ranging from sustainability and digital to data protection rules.
Aligning vertical and horizontal frameworks remains a challenge, often making compliance complex and resource-intensive for companies. MedTech Europe strives to support its members by keeping them informed about the evolving legislative landscape and providing leadership and expertise on key legal issues.