Pharma IT Insights
Drug-Device Combination Products and the Impact of the EU MDR
By Anne Louise Kirkegaard
February 9, 2025
Pharma IT Insights
Drug-Device Combination Products and the Impact of the EU MDR
By Anne Louise Kirkegaard
February 9, 2025
The regulatory landscape for drug-device combination products in the EU continues to evolve. The implementation of the EU's Medical Device Regulation (MDR) has introduced significant regulatory challenges, including compliance with Article 117 of the Regulation.
Understanding and adapting to these regulatory shifts is essential for ensuring market access, maintaining compliance, and fostering innovation. This Insight provides an overview of how Article 117 of the MDR impacts authorization and commercialization of drug-device combination products and practical steps to navigate these challenges.
What is a drug-device combination product?
In simple terms, a drug-device combination product is a medical product that integrates a drug and a device into a single unit. In the EU, there is no single legal framework for drug-device combination products. Instead, these products that combine a medicinal product and a medical device are regulated based on their primary mode of action under either medicinal product or medical device legislation
What is the EU MDR?
The EU MDR (European Medical Device Regulation) is a stringent regulatory framework governing medical devices in the EU. Replacing the previous Medical Device Directive (MDD), it enhances patient safety, transparency, and post-market surveillance. Compliance with EU MDR is essential for market access, requiring rigorous clinical evaluation, UDI implementation, and stricter reporting for medical device manufacturers.
Action tip: Establish a robust EU MDR compliance strategy by conducting a gap analysis early, ensuring documentation, clinical data, and post-market surveillance processes align with regulatory requirements.
How does Article 117 of the EU MDR impact drug-device combination products?
Article 117 of the EU Medical Device Regulation (MDR) introduces a key regulatory requirement for drug-device combination products. Most notably, it mandates that if a company is bringing a drug-device combination product onto the market as a single integral drug-device combination product, the device component must meet the General Safety and Performance Requirements (GSPR) under MDR.
This means that if the device does not already have a CE mark, a Notified Body Opinion (NBOp) is required as part of the Marketing Authorisation application (MAA). If applicable, this must be included in Module 1 of the MAA.
Action tip: Get device expertise on board early – Ensure cross-functional collaboration between pharmaceutical and medical device regulatory teams to ensure a smooth approval process.
How can I obtain a Notified Body Opinion (NBOp) for a drug-device combination product?
Notified bodies are designated by EU member states to assess product conformity before they enter the EU market. A list of notified bodies under the MDR can be found on the EU’s website.
To obtain an NBOp, take the following steps:
- Identify a Notified Body – Pharmaceutical companies must engage with an Notified Body designated for the specific type of medical device early in the development process.
- Prepare Technical Documentation – Submit detailed evidence that the device component complies with MDR’s GSPR.
- Notified Body Review – The Notified Body assesses whether the device component meets regulatory requirements and issues an NBOp.
- Incorporate NBOp into MAA – The European Medicines Agency (EMA) or national authorities will consider the NBOp when reviewing the overall medicinal product dossier.
Action tip: Initiate Notified Body discussions at least 12-18 months before MAA submission. Generating the necessary technical data takes time, so don’t push off the device component.
How can I ensure compliance with EU MDR?
With the MDR fully in effect, companies developing drug-device combination products must navigate new compliance challenges, including Article 117 requirements and the NBOp process. Ensuring early engagement with device experts, aligning drug product and medical device regulatory strategies, and integrating lifecycle management considerations are all crucial for a smooth regulatory approval process.
Need additional support? Our Regulatory Affairs (RA) consulting team is here to provide personalized guidance, from early development planning and dossier submission to market access and post-approval surveillance. Whether you’re navigating new EU Pharma Legislation or ensuring full compliance with the EU Medical Device Regulation, our team’s expertise can help your organization with regulatory consulting services to stay ahead of the curve and achieve sustainable success.
Where can I learn more about 2025 EU Regulatory Affairs updates?
To help you stay ahead of these regulatory changes, join our upcoming event: EU Regulatory Affairs 2025: Latest Updates and Expert Insights. You’ll gain practical insights from industry experts and enhance your compliance toolkit to ensure market success.
Date: February 25, 2025
Location: Hotel Ottilia, Bryggernes Plads 7,1799 Copenhagen
Time: 8:00 AM – 17:00 PM
Key Topics include:
• New EU Pharma Legislation – An Overview of the Key Aspects and Status of Implementation
• Orphan Medicines and the Impact of the New EU Pharma Legislation
• Pediatric Development and the Impact of the New EU Pharma Legislation
• Clinical Trial Regulation – Status and First Experiences After 2 Years
• EU PRIME Scheme – How Its Introduction Has Affected Innovative Drug Development
• New EU HTA Regulation – An Overview of What’s New and Current Implementation Status
• Drug-Device Combinations in the EU – Impact of the New Medical Device Regulation
About the author
Anne Louise Kirkegaard serves as Pharma IT’s Director of Regulatory Affairs & Medical Writing. She holds more than 20 years’ experience from the biotech and pharmaceutical industry working with Regulatory Affairs in development, registration and post-approval of drug products, drug-device combination products and cosmetics.
