ICT&health February 10, 2025
Article 117 introduces complex compliance requirements impacting drug-device combination products, necessitating enhanced collaboration between pharmaceutical and device teams to ensure regulatory approval.
Regulatory Framework and Impact
As of February 2025, manufacturers of drug-device combination products face heightened regulatory scrutiny under Article 117 of the EU MDR. The regulation requires manufacturers to obtain a Notified Body Opinion (NBOp) for device components without CE marking as part of their Marketing Authorization Application (MAA) [1]. This significant change affects 80% of drug-device combinations, requiring comprehensive technical documentation and compliance with General Safety and Performance Requirements (GSPR) [1][2].
Implementation Challenges and Strategic Approaches
Industry experts recommend initiating Notified Body discussions at least 12-18 months before MAA submission to ensure adequate preparation of technical documentation...
Today's Sponsors
Today's Sponsor