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What’s your approach to meeting EU MDR Article 117?

1 June 2024
MediPhorum Drug Delivery
Victoria Ludlow
Program Manager

Across the European Medical Device Regulation (EU MDR), adhering to General Safety and Performance Requirements (GSPRs) forms the cornerstone of compliance. Manufacturers face the challenge of addressing significant changes to a product that already has a Notified Body Opinion, conformity testing, and nuanced aspects like biocompatibility and human factors validation for new Single Integral Drug-Device Combination Products (DDCs).

The submission of reports to Notified Bodies (NBs) for opinion introduces additional validation challenges, while discrepancies in approaches among NBs and EU competent authorities further underscore the complexities.

Manufacturers must demonstrate compliance with the GSPRs and navigate the delicate balance of mitigating regulatory and commercial burdens of proof; this requires strategic approaches to evidence provision. Optimizing engagement with dedicated reviewers for Article 117 compliance therefore becomes paramount for ensuring a streamlined process for scrutiny.

To help guide members through this hugely complex area, MediPhorum has published Implementation of Article 117 of European Union (EU) Medical Devices Regulation (MDR) General Safety and Performance Requirements (GSPRs): A MediPhorum opinion report: 2023 update .

The paper reviews these challenges and how the selection of an NB introduces its own set of complexities, with the need to navigate processes and criteria. This includes considering NB timelines and the potential utilization of fast-track options to expedite assessments. Navigating the submission for Notified Body Opinions within EU MDR Article 117 brings insights into risk management, information sharing, platform approaches, and the inconsistency of NB reviews across different instances.

This paper also discusses how the registration of complex devices adds a layer of difficulty, requiring meticulous attention to detail and compliance with the regulatory framework.

Highlights of our paper include how:

  • GSPRs are the main criteria for ensuring the safety and performance of Single Integral DDCs in the EU market – yet there may be variations in how different manufacturers interpret and apply them, requiring careful justification and documentation
  • A significant change to a DDC may trigger the need for a new or updated Notified Body Opinion – yet the definition of a significant change is not clear, creating uncertainty and inconsistency among manufacturers and regulators
  • Human Factors studies are important for evaluating user interaction and safety aspects of medical devices, but they have some complexities for DDCs.

The paper also begins to explore how to develop a response to the dynamic landscape of DDCs and the growing complexity of the associated devices. The growing regulatory sophistication towards intricate delivery systems (e.g., on-body delivery systems and nasal inhalers) will also encompass precision medicine, curative therapies, and software-device integration for diagnostics and disease management.

The authors’ opinions and guidance highlight the urgency for license holders and manufacturing partners to address the rapidly approaching critical issues and challenges that accompany the development and registration of complex medical devices under the EU MDR.

EU MDR Article 117 demands a comprehensive approach to compliance, addressing GSPRs, significant changes, labelling requirements, and engagement with regulatory bodies. Manufacturers must strategically navigate these challenges to ensure adherence while bringing their innovative and complex devices to market in alignment with regulatory expectations.

What’s your approach?

For more information, download the paper here and contact Victoria Ludlow, Program Manager, MediPhorum, at victoria.ludlow@biophorum.com

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