What is a drug-device combination product and how is it regulated in Egypt?

A drug device combination product is a healthcare solution that physically or chemically combines a drug or biologic component with a medical device. In Egypt, these are regulated by the Egyptian Drug Authority (EDA). The EDA evaluates the Primary Mode of Action (PMOA) of the combination device to determine whether the primary review will be handled by the Central Administration of Pharmaceutical Products or the Central Administration of Medical Devices.

What is the significance of EU MDR Article 117 for combination products entering Egypt?

Under EU MDR Article 117, any medicinal product that features an integral drug device combination (such as a pre-filled pen injector) must include a Notified Body Opinion (NBOp) confirming that the device part meets general safety and performance requirements (GSPR). Since the EDA relies heavily on EU MDR as a benchmark, having this documentation compiled and audited is critical for achieving smooth fast-track approval in Egypt.

Can Operon Strategist help write the risk management documentation for a combination product?

Yes. Writing documentation for combination products requires a unified approach that satisfies both drug GMPs and medical device risk standards (ISO 14971). We author comprehensive, audit-ready risk management portfolios, biocompatibility evaluations, and usability engineering files that systematically bridge the safety data requirements of both pharmaceutical and device regulatory reviewers.

OPERON ELEVATEPLUS | DRUG-DEVICE COMBINATION PRODUCTS DOCUMENTATION

Drug-Device Combination Product Regulatory Documentation Services in Egypt

Operon Strategist provides specialized consulting for any drug device combination product, supporting manufacturers in defining EDA registration pathways, preparing compliant design documentation, managing product risks, and compiling submission-ready technical files. Our integrated approach aligns both pharmaceutical and combination product medical device regulatory requirements, reducing uncertainty and accelerating market access across Egypt and global reference markets.

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Operon ElevatePlus
Drug-Device Combination Products Documentation Service Portfolio

Regulatory Strategy & Product Classification

Design & Development Documentation

Risk Management & Quality Systems

GSPR & Essential Requirements Compliance

Technical Documentation & Validation Support

Article 117 of EU MDR 2017/745 amends Directive 2001/83/EC & Notified Body Opinion (NBOp) Support

What Sets Us Apart

Global exposure, structured thinking, and execution-ready expertise

Regulatory and documentation support for combination products – we support manufacturers in navigating complex dual-authority pathways through integrated technical strategy development. Our services include drug device combination classification, regulatory pathway assessment, design controls, and clinical safety risk documentation. This structured approach reduces regulatory risk, ensures compliance with active mdr combination products frameworks, and enables a seamless, compliant path to EDA 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