EU MDR Article 117 Drug-Device Combination Products
For medicinal products incorporating an integral device part, Article 117 addresses evidence of conformity with applicable MDR Annex I requirements. Where the required conformity evidence is absent, a Notified Body opinion is needed if the device part, considered separately, would require Notified Body involvement. We assess applicability before preparing the device evidence dossier.
Article 117 Compliance & NBOp Deliverables
Combined Product Risk and Delivery Realities
We align the device-constituent risks, usability protocols and validation evidence directly with the combined product clinical use and drug characteristics, rather than treating the device component as an isolated checklist.
Typical Product Types
• Pre-filled syringes & pens
• Auto-injectors & wearable bolus injectors
• Metered dose inhalers (MDIs) & DPIs
• Transdermal delivery systems
• Implants with drug-eluting functions
Need an NBOp Dossier?
Prepare your device constituent documentation to interface smoothly with EMA or National Competent Authority MAA submissions.
Request NBOp SupportSecure Your Notified Body Opinion under EU MDR Article 117
Our combination product specialists integrate medical device engineering with pharmaceutical regulatory submissions.