OPERON ELEVATEPLUS | DRUG-DEVICE COMBINATION PRODUCTS DOCUMENTATION
Drug-Device Combination Product Consulting for Global Regulatory Compliance
Operon Strategist provides specialized drug-device combination product consulting, supporting manufacturers in defining regulatory pathways, preparing compliant design and development documentation, managing product risks, and compiling submission-ready technical files.
Our integrated approach aligns both drug and medical device regulatory requirements, reducing uncertainty and accelerating market access across global markets.
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Operon ElevatePlus
Drug-Device Combination Product Documentation Service Portfolio
Six services cover drug-device combination product documentation, from classification and strategy to risk files, GSPR, and Notified Body Opinion support. Our drug device combination product consulting starts by assigning the Primary Mode of Action (PMOA) and the lead authority.
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, and design history file (DHF) & medical device file (formerly 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 (EU MDR 2017/745) & Notified Body Opinion (NBOp) Support
Article 117 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 as a Medical Device Combination Product Consultant
Global exposure, structured thinking, and execution-ready expertise
Extensive Experience Across Drug, Device & Combination Product Regulations
Expertise in FDA 21 CFR Part 4, FDA QMSR, ISO 13485, & EU MDR Requirements
Global Consulting Support from Concept Development to Regulatory Submission
Proven Capability in Risk Management, CAPA, DHF & Audit Readiness
Regulatory and documentation support for drug–device combination products – we support manufacturers in navigating complex regulatory pathways through integrated strategy and documentation development. Our services include product classification, regulatory pathway assessment, design and risk documentation, and implementation of CAPA and quality systems. This structured approach reduces regulatory risk, strengthens audit readiness, and enables timely progression toward market approval.
As a medical device combination product consultant, Operon supports pharmaceutical companies, device manufacturers, biotechnology organizations, and contract manufacturers. Our combination product regulatory consulting covers classification, PMOA, design controls, and submissions, and our regulatory affairs combination products team handles PMS and CAPA documentation. The same files feed your quality management system (QMS), US FDA and CE Marking submissions.
Operon Combination Product Regulatory Consulting 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 About Drug Device Combination Products
What is a drug device combination product?
A drug device combination product is a therapeutic product that combines a drug and a medical device into a single product or integrated system. Common drug device combination products include prefilled syringes, insulin pens, drug-eluting stents, transdermal patches, and inhalers.
How are combination products regulated by the FDA?
The FDA regulates combination products based on their Primary Mode of Action (PMOA). The lead review is assigned to the appropriate FDA center—CDER (drugs), CDRH (devices), or CBER (biologics)—while other centers provide input as needed.
In the US drug device combination market, FDA’s Office of Combination Products assigns the lead center based on PMOA.
What is Article 117 under EU MDR?
Article 117 of the EU MDR requires manufacturers of certain medicinal products incorporating a medical device to obtain a Notified Body Opinion (NBOp) confirming that the device component complies with the applicable General Safety and Performance Requirements (GSPRs).
How is the Primary Mode of Action (PMOA) determined?
PMOA is determined by identifying which component—drug, device, or biologic—provides the product’s primary therapeutic effect. This determines the applicable regulatory pathway and lead regulatory authority.
What documentation is required for a drug device combination product?
Documentation requirements typically include product classification, design and development records, risk management files, technical documentation, clinical or performance evidence, manufacturing information, labeling, and regulatory submission documents based on the applicable market and regulatory pathway.
Which standards apply (ISO 13485, ISO 14971, IEC 62366)?
Combination product regulatory requirements draw on ISO 13485 for quality management systems, ISO 14971 for risk management, and IEC 62366 for usability engineering. Additional pharmaceutical GMP and market-specific requirements may also apply.
What is the role of a Notified Body Opinion (NBOp)?
A Notified Body Opinion (NBOp) assesses whether the medical device component of certain drug-device combination products complies with the relevant EU MDR safety and performance requirements before market authorization.
How long does combination product approval take?
Approval timelines depend on the product type, regulatory pathway, documentation quality, and jurisdiction. Most approvals take several months to over two years, depending on the complexity of the product and the regulatory review process.
Which regulatory authorities govern drug device combination products?
The drug device combination market spans all of them, and combination product regulatory consulting helps you plan for each authority in your target markets. For market sizing and competitor detail, see market intelligence.
How can Operon Strategist support drug device combination product documentation?
Our experts provide end-to-end drug-device combination product documentation support, including regulatory strategy, product classification, technical documentation preparation, risk management, design control documentation, gap assessment, and submission support to help manufacturers achieve regulatory compliance efficiently.
Which industries can benefit from your drug device combination product consulting services?
Our drug device combination product consulting is suitable for pharmaceutical companies, medical device manufacturers, biotechnology organizations, contract manufacturers, and innovators developing combination products for global markets.
Planning a Drug-Device Combination Product Approval
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