In the medical device and pharmaceutical industries, regulatory compliance is crucial for ensuring patient safety and product effectiveness. A significant requirement under the EU Medical Device Regulation (MDR 2017/745) is the Notified Body Opinion (NBOp) process, outlined in Article 117. This process applies to drug-device combination (DDC) products, ensuring that the medical device component meets required safety and performance standards prior to its integration into a medicinal product. For manufacturers of drug-device combination products, obtaining a Notified Body Opinion is essential for market access. While this requirement enhances patient safety and standardizes the evaluation of medical device components, it also introduces new compliance challenges that manufacturers must navigate effectively.
What is the Notified Body Opinion Process?
The NB Opinion process is a regulatory pathway where manufacturers of integral drug-device combination products must obtain an independent evaluation from a Notified Body (NB) to ensure compliance with the General Safety and Performance Requirements (GSPRs) listed in Annex I of MDR. The aim is to verify that the medical device part of the combination product meets regulatory and safety requirements before market authorization.
Why Does the NBOp Process Matter for Medical Device Manufacturers?
Previously, drug-device combination products were regulated primarily under medicinal product guidelines. With MDR in full force, the device component now requires independent verification from a Notified Body to confirm compliance with the General Safety and Performance Requirements (GSPRs) in Annex I of the regulation.
Key Steps in the NB Opinion Process
Manufacturer Submission
The manufacturer compiles and submits technical documentation for the device component to a Notified Body.
Documentation includes:
Notified Body Assessment
The NB reviews the submitted data to determine if the device component meets MDR requirements.
Evaluation considers:
Issuance of Notified Body Opinion
Integration into Market Authorization Application (MAA)
Regulatory Decision
Challenges and Considerations for manufacturer:
Challenges for Manufacturers:
Manufacturers face several significant hurdles, including complex documentation demands that require detailed clinical and performance data, which increases workload and compliance costs. Additionally, bottlenecks with a limited number of designated Notified Bodies can lead to delays in assessments, thereby slowing market access. There are also consistency issues, as varying interpretations of MDR requirements among Notified Bodies can result in different compliance expectations.
Manufacturers must be aware of:
Conclusion
The Notified Body Opinion process plays a crucial role in regulatory compliance for drug-device combination products to market under MDR. By undergoing independent assessment, manufacturers can enhance product safety, streamline market entry, and ensure compliance with MDR requirements. By understanding key challenges, optimizing technical documentation, and engaging proactively with Notified Bodies, manufacturers can expedite approval, reduce compliance risks, and ensure safe, high-performance medical devices.
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