EU MDR Compliance for Drug-Eluting Combination Device
Mid-size European pharmaceutical company
The Challenge
A mid-size pharmaceutical company developing a drug-eluting implantable device needed to navigate the dual regulatory pathway under EU MDR Article 117. Their internal teams had deep pharmaceutical expertise but limited experience with medical device regulatory requirements. The combination product required coordination between the drug approval process and the medical device conformity assessment, including a Notified Body Opinion on the device constituent.
Our Approach
Swiss MPC began the engagement with a comprehensive regulatory strategy mapping exercise tailored to the Article 117 pathway for combination products where the drug is the principal mode of action. We worked closely with the client's pharmaceutical regulatory team to define the precise boundary between the drug and device constituents, establishing a clear classification rationale that aligned with the European Commission's guidance on borderline products. This strategic foundation ensured that all subsequent documentation and submissions addressed the correct regulatory requirements from both the pharmaceutical and medical device perspectives.
A critical element of the project was managing the Notified Body Opinion (NBO) process for the device constituent. Our regulatory team prepared the complete NBO application dossier, including the device constituent's technical documentation in accordance with EU MDR Annex II, essential requirements compliance, biocompatibility assessment per ISO 10993, and a detailed description of the drug-device interaction mechanisms. We identified and engaged an appropriately designated Notified Body early in the process, conducted a pre-submission meeting to align expectations, and managed all queries and supplementary information requests through to a successful opinion on first submission.
Bridging the clinical evidence between pharmaceutical and device regulatory frameworks presented a unique challenge. Our clinical affairs specialists developed an integrated clinical evaluation strategy that leveraged existing pharmaceutical clinical trial data while addressing the device-specific clinical evidence requirements under MDR Article 61 and MEDDEV 2.7/1 Rev. 4. We prepared a Clinical Evaluation Report for the device constituent that demonstrated the safety and performance of the device element within the context of the overall combination product, including analysis of device-related adverse events and device failure modes from the pharmaceutical clinical programme.
The technical documentation for the device constituent was developed to the full rigour of EU MDR Annex II requirements. This encompassed design and manufacturing documentation, risk management per ISO 14971 with specific attention to drug-device interaction risks, sterilization validation, shelf-life and packaging verification, and usability engineering per IEC 62366-1. Our team ensured traceability between the pharmaceutical Marketing Authorisation Application and the device technical file, so that the competent authority and Notified Body received a coherent and consistent submission package.
Results
Achieved
EU market approval
1st attempt
NBO accepted without major findings
Zero
Major findings at regulatory audit
2 months
Ahead of projected timeline
“Swiss MPC brought exactly the expertise we were missing. Our pharmaceutical team knew the drug side inside out, but the device regulatory landscape was unfamiliar territory. Their consultants bridged both worlds seamlessly, translating between pharmaceutical and medical device requirements in a way that gave our leadership team full confidence in the submission strategy. The fact that we achieved a clean Notified Body Opinion on first submission speaks volumes about the quality of their work.”
Director of Regulatory Affairs
European Pharmaceutical Company
Topics & Standards
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