Drug-Device Combination Products & Article 117

For medicinal products incorporating an integral device constituent part (such as pre-filled pens, auto-injectors, or inhalers), Article 117 mandates evidence of conformity with applicable MDR Annex I GSPRs and a Notified Body Opinion (NBOp). We prepare and defend the complete device evidence dossier.

Assess Your Article 117 Strategy

Article 117 Compliance & NBOp Deliverables

Article 117 applicability assessment (integral vs co-packaged / referenced combinations)

Device constituent qualification, intended purpose and applicable MDR GSPR mapping

Risk management file (ISO 14971) focused on device-drug interactions and delivery errors

Human factors & usability engineering studies for delivery devices (IEC 62366-1)

Functional performance, dose accuracy and delivery repeatability testing

Biocompatibility (ISO 10993) and chemical characterization of fluid path materials

Sterility assurance, terminal sterilization validation and packaging integrity

Technical documentation preparation specifically tailored for Notified Body Opinion (NBOp)

Direct Notified Body interaction, deficiency defense and post-opinion change impact assessment

Expert Differentiator

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 Support

Secure Your Notified Body Opinion under EU MDR Article 117

Our combination product specialists integrate medical device engineering with pharmaceutical regulatory submissions.

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