Live! #76 – MDCG 2023-7: New Clinical Evidence Pathways for Legacy and New Devices

Device Advice by RQM+

This show was recorded 22 February 2024. We encourage you to download the supplemental PDF content for this session by completing the form on this page. Please join us live for future shows and ask your own questions! We hold one RQM+ Live! panel discussion per month and you can sign up at the ⁠Knowledge Center⁠ or ⁠Events⁠ pages at RQMplus.com.

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Summary

The panelists discuss the requirements for claiming equivalence under the MDR and provide examples of devices that are impacted. They also address actionable steps and next steps for manufacturers. The discussion covers the importance of PMCF studies and the evidence levels required. The panelists also clarify the requirements for claiming equivalence to devices with expired CE marks and within product families. The conversation covers topics such as technical equivalence and benchtop testing data, PMCF studies and registries, changes in PMCF under MDR, the difference between level 3 data producing registries and level 4 data producing retrospective studies, the purposes of registries and surveys, accessing data without a contract, the need for sufficient clinical evidence, acceptance of the new interpretation by notified bodies, reviewers' perspective on equivalence, the timing of the guidance, and action items for manufacturers.

Takeaways

• Manufacturers can claim equivalence with other devices to leverage their clinical data, even for new devices.
• The MDCG 2023-7 guidance clarifies the requirements for claiming equivalence under the MDR.
• PMCF studies must generate level four data for class three and implantable devices.
• Claiming equivalence to devices with expired CE marks can be high-risk and should be approached with caution.
• Claiming equivalence within product families requires careful consideration of the differences in materials and clinical indications. Technical equivalence requires connecting a story with appropriate data.
• PMCF studies have changed under MDR, with the nomenclature shifting from proactive and reactive to general and specific activities.
• Registries provide continuous data over the lifetime of a device, while surveys offer a snapshot in time.
• Manufacturers can access data without a contract by relying on publicly available information, reverse engineering, or comparative testing.
• The need for sufficient clinical evidence and the requirement to demonstrate clinical, technical, and biological equivalence remain unchanged.
• Notified bodies are accepting the new interpretation of equivalence.
• Manufacturers should revisit their product portfolios and consider leveraging the new guidance.
• Understanding the nuances of the guidance document is crucial.
• Manufacturers should have discussions with their notified bodies to align on the application of the guidance.
• Consider salvaging indications for devices that have been narrowed and explore the possibility of conducting PMCF studies.
• Read the guidance document thoroughly and seek expert assistance if needed.

Chapters

• 00:00 Introduction and Agenda
• 01:06 Introduction to RQM Plus
• 01:31 Introduction to Panelists
• 10:09 Examples of Devices Impacted
• 21:26 PMCF Studies and Evidence Levels
• 25:03 Claiming Equivalence to Devices with Expired CE Marks
• 28:50 Claiming Equivalence to Multiple Manufacturers and Devices
• 32:18 Claiming Equivalence within Product Families
• 35:00 Technical Equivalence and Benchtop Testing Data
• 35:30 PMCF Studies and Registries
• 36:36 Changes in PMCF under MDR
• 37:32 Level 3 Data Producing Registries vs Level 4 Data Producing Retrospective Studies
• 39:04 Different Purposes of Registries and Surveys
• 40:29 Accessing Data without a Contract
• 43:05 What Hasn't Changed: Need for Sufficient Clinical Evidence
• 44:20 Acceptance of the New Interpretation by Notified Bodies
• 46:17 Reviewers' Perspective on Equivalence
• 52:28 Timing of the Guidance and Revisiting Product Portfolio
• 55:05 Action Items for Manufacturers

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