OPERON ELEVATEPLUS | DRUG-DEVICE COMBINATION PRODUCTS DOCUMENTATION
Drug-Device Combination Products - Regulatory & Development Services in Germany
Operon Strategist provides specialized consulting for drug device combination products in Germany, supporting manufacturers in defining strict local and European regulatory pathways. We guide you in preparing compliant design and development documentation, managing product risks, and compiling submission-ready technical files for authorities like BfArM and the EMA. Our integrated approach aligns both medicinal and medical device requirements—ensuring full compliance for EU MDR combination products—which reduces uncertainty and accelerates your market access across Europe and globally.
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Operon ElevatePlus
Drug-Device Combination Products Documentation Service Portfolio
Regulatory Strategy & Product Classification
Determine drug-device combination product classification and regulatory applicability
Identify applicable regulatory pathways under FDA 21 CFR Part 4, 21 CFR Part 820/QMSR, EU MDR 2017/745, ISO 13485, ISO 14971 & ICH guidelines
Assess Primary Mode of Action (PMOA) and lead regulatory authority
Develop market-specific regulatory and approval strategy roadmap
Design & Development Documentation
Design planning, user needs, design inputs & outputs documentation
Design transfer, change control, Structured Design History File (DHF) & Device Master Record (DMR) documentation
Design verification, validation & design review documentation support
Technical File, Design Dossier & Product Specifications File preparation for global compliance
Risk Management & Quality Systems
ISO 14971-compliant Risk Management File, hazard identification & risk analysis
Use-related risk analysis, FMEA/dFMEA/pFMEA & Fault Tree Analysis (FTA)
Benefit-risk evaluation, risk control, residual risk & post-production risk review
IEC 62366-1 usability engineering, human factors & formative/summative studies
GSPR & Essential Requirements Compliance
EU MDR Annex I General Safety & Performance Requirements (GSPR) checklist preparation
Mapping of applicable standards, testing evidence & compliance documentation
Essential Requirements Checklist support for legacy MDD products
GSPR compliance review aligned with EU MDR technical documentation requirements
Technical Documentation & Validation Support
Product description, intended use, formulation & device specification documentation
Clinical evaluation, clinical evidence, performance testing & software documentation
Biocompatibility, sterilization, packaging & shelf-life validation documentation
Labeling, IFU, CAPA, complaint handling, PMS & PMCF documentation support
Article 117 of EU MDR 2017/745 amends Directive 2001/83/EC & Notified Body Opinion (NBOp) Support
Article 117 of EU MDR 2017/745 amends Directive 2001/83/EC applicability assessment for medicinal products with device components
Technical documentation, GSPR, risk management & usability evidence compilation
Coordination with Notified Bodies (NB) and deficiency response support
Support for NB review of design, clinical, IFU, sterility & packaging validation documentation
What Sets Us Apart
Global exposure, structured thinking, and execution-ready expertise
Extensive Experience Across Drug, Device & Combination Product Regulations
Expertise in FDA 21 CFR Part 4, 21 CFR Part 820, ISO 13485, & EU MDR Requirements
Global Consulting Support from Concept Development to Regulatory Submission
Proven Capability in Risk Management, CAPA, DHF & Audit Readiness
Delivering robust documentation support for an integral drug device combination requires a deeply integrated strategy. We support German manufacturers in navigating complex pathways through precise product classification, EU MDR Article 117 assessments, design and risk documentation, and the implementation of CAPA and quality systems. This structured approach seamlessly bridges pharmaceutical and medical device frameworks, reducing regulatory risk, strengthening audit readiness for your Notified Body Opinion (NBOp), and enabling timely progression toward market approval.
Operon Drug-Device Combination Products Documentation Advantage
Expert regulatory strategy, design control, and compliance support for drug-device combination products under global regulatory frameworks such as FDA and EU MDR
End-to-End Regulatory Consulting for Drug-Device Combination Products
Integrated Approach Covering Both Drug & Device Compliance Requirements
Strong Alignment with Quality Management & Design Control Systems
Audit-Ready Documentation & Regulatory Submission Support
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frequently asked questions
What is the impact of EU MDR Article 117 on drug-device combination products in Germany?
Article 117 of the EU MDR amends the Medicinal Products Directive (2001/83/EC). If your combination product is regulated primarily as a medicinal product (where the drug performs the principal action), you must obtain a Notified Body Opinion (NBOp). This opinion confirms that the device component meets the relevant General Safety and Performance Requirements (GSPRs) before you can submit your marketing authorization application to BfArM or the EMA.
How do you differentiate between an integral drug-device combination and a co-packaged combination product?
An integral drug-device combination product forms a single, non-reusable entity where the drug and device are physically combined (such as a prefilled syringe). It is regulated primarily as a medicinal product and requires an NBOp for the device aspect. A co-packaged combination product contains a separate device and drug inside the same packaging (such as a reusable injection pen packed with medicine cartridges). In this case, the device component must hold its own standalone CE Mark certification under the EU MDR.
What technical documentation is essential for a combination product medical device file?
The technical file must bridge both pharmaceutical and medical device frameworks. Critical documentation includes a detailed Design History File (DHF), risk management analysis under ISO 14971, usability engineering data, sterilization validations, and robust biocompatibility studies (ISO 10993). Additionally, you must map out a complete GSPR compliance checklist specifically targeting the device’s physical and performance features.
What role does BfArM play in the approval of combination drug-device products?
BfArM (the Federal Institute for Drugs and Medical Devices) is Germany’s national competent authority. For combination products where the primary mode of action is pharmacological, immunological, or metabolic, BfArM handles the core marketing authorization evaluation. They review the comprehensive clinical and pharmaceutical data, while requiring the manufacturer to provide the Notified Body Opinion to validate the safety of the device constituent.
Planning a Drug-Device Combination Product Approval
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