Drug-device combination products are at the forefront of innovation, offering integrated solutions that enhance patient care. These products, which combine medicinal drugs and medical devices, present unique Regulatory challenges, particularly within the European Union (EU). Article 117 of the Medical Device Regulation (MDR) plays a crucial role in governing these combination products. Understanding and complying with Article 117 is essential for pharmaceutical companies looking to market their products in the EU.
Understanding Article 117
Article 117 of the MDR, which came into effect on May 26, 2021, stipulates that any drug-device combination product incorporating a device component must undergo a conformity assessment by a Notified Body. This assessment ensures that the device component meets the General Safety and Performance Requirements (GSPR) specified in the MDR. The Notified Body's opinion on the device's conformity must be included in the Regulatory submission for the combination product.
The goal of Article 117 is to enhance patient safety by ensuring the drug and device components of combination products adhere to stringent safety and performance standards. Compliance with this regulation is mandatory for market approval in the EU, making it a critical consideration for pharmaceutical companies.
Key Steps to Compliance with Article 117
Achieving compliance with Article 117 involves a comprehensive approach that includes understanding Regulatory requirements, implementing robust quality management systems, conducting thorough audits, and maintaining meticulous documentation. Here’s how to stay compliant:
Understanding Regulatory Requirements
The first step in achieving compliance is a thorough understanding of the Regulatory requirements outlined in Article 117. This includes identifying the applicable GSPR for the device component and understanding the documentation required for the conformity assessment. Freyr Solutions offers expert consulting services to help you navigate these requirements, providing a clear roadmap for compliance.
Implementing Robust Quality Management Systems (QMS)
A robust Quality Management System (QMS) ensures your drug-device combination products meet the safety and performance standards. Freyr Solutions provides comprehensive QMS development and implementation services tailored to the unique needs of combination products. Our experts ensure that your QMS aligns with the requirements of Article 117, facilitating smooth Regulatory submissions.
Conducting Thorough Audits and Inspections
Regular audits and inspections are crucial for maintaining compliance with Article 117. Freyr Solutions conducts thorough internal audits to identify gaps in your compliance processes and provides actionable recommendations for improvement. Our audit services also prepare you for external inspections by Notified Bodies, ensuring you are well-prepared to demonstrate conformity with the GSPR.
Effective Documentation Management
Proper documentation is a cornerstone of Regulatory compliance. Freyr Solutions offers expert support in managing the extensive documentation required for Article 117 compliance, including technical files, design dossiers, and quality system documentation. Our team ensures all necessary documents are complete, accurate, and readily accessible for Regulatory review.
Continuous Monitoring and Updates
Regulatory requirements are constantly evolving, making continuous monitoring and updates essential. Freyr monitors the Regulatory changes and updates your compliance processes accordingly. This proactive approach ensures that your drug-device combination products remain compliant with the latest standards, reducing the risk of non-compliance.
Conclusion
Staying compliant with Article 117 is essential for the successful development and marketing of drug-device combination products in the EU. By partnering with Freyr, pharmaceutical companies can ensure their products meet the highest safety and performance standards, facilitating smooth Regulatory submissions and market access. Consult our experts today!
