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.

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.

Take the next step

Connect with our experts to discuss your next big medical device idea

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

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