MDCG 2023-7: New Clinical Evidence Pathways for Legacy and New Devices

MDCG 2023-7 was published in December 2023, providing much needed clarification on the use of equivalence for implantable and Class III devices, and when these devices can be exempted from mandatory clinical investigations. The guidance corrects a long-standing misperception previously held by many in MedTech, namely, that equivalence cannot be claimed with another manufacturer’s device without a contract allowing full access to the technical documentation on an ongoing basis. This in turn provides new opportunities to expand clinical evidence packages, helping to maintain devices and indications in the EU market, as well as potentially supporting new product development.

This session will explain the background to this guidance and how it clarifies the legal text of the MDR, and how it can be used to support clinical evidence requirements for devices still in the process of transition from the Directives to EU MDR, as well as how it can be used to support new product development. It will also discuss how “sufficient access” to the data required to justify equivalence claims can be demonstrated.

After attending the panel discussion, you will be able to:

• Ensure they have the strongest possible clinical data packages available for their devices, giving their devices the best chance of staying on / entering the EU market with the full set of indications
• Provide a strong rationale for “sufficient access” to the data required to establish equivalence, reducing potential notified body findings

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Panelists: 

• Amie Smirthwaite BEng, Ph.D., FRAPS, – Senior Vice President, Scientific Affairs
• Jaishankar (Jai) Kutty, Ph.D. – Vice President, Global Regulatory Affairs
• Jon Gimbel, Ph.D. – Vice President, Technical Consulting Services
• Bethany Chung, Ph.D., RAC – Senior Principal Regulatory Scientist

BONUS: If you want to get the most out of the session, be sure to watch this summary video from Jai beforehand. This video covers the basics of why this is an important topic and we'll answer your questions during the discussion.