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 [1]. Cross-functional collaboration between pharmaceutical and medical device regulatory teams has become essential for successful approval processes. As emphasized by Anne Louise Kirkegaard, getting device expertise involved early is crucial for navigating these complex requirements [1]. The upcoming EU Regulatory Affairs 2025 event, scheduled for February 25, 2025, in Copenhagen, will address these challenges alongside other regulatory updates [1].
AI Integration and Future Compliance
The regulatory landscape is further complicated by the recent implementation of the EU AI Act (Regulation EU 2024/1689), which came into force on February 2, 2025 [5]. For drug-device combinations incorporating AI components, manufacturers must now comply with both MDR Article 117 and the AI Act requirements [3]. The AI Act introduces additional obligations for high-risk AI systems, which will take full effect by August 2027 [3], requiring manufacturers to adapt their quality management systems to address both regulatory frameworks [3][5].
Strategic Recommendations
As we progress through 2025, manufacturers are advised to establish robust compliance strategies including comprehensive gap analysis and enhanced documentation processes [1]. The European Commission’s recent introduction of Commission Implementing Regulation (EU) 2025/117 on February 1, 2025, provides additional guidelines for drug-device regulations [6]. Manufacturers should focus on developing integrated approaches that address both traditional regulatory requirements and emerging technological considerations, particularly in cases where AI systems are incorporated into drug-device combinations [3][5].