Essentials for Clinical Evaluation of Medical Devices

The latest updates to EU MDR & IVDR place increased significance on clinical investigations by requiring all classes of medical devices to have a Clinical Evaluation Report.

Further, these regulations stipulate that a Post Market Clinical Follow-up process be in-place for all medical devices, or to provide appropriate reasoning for not having a follow-up study.

The Globiox team will discuss how these changes may impact your approach, how to optimally demonstrate equivalency in your report and how to establish a continuous follow-up process for post market. With special consideration given to combination devices and software as a medical device, the team will further break down the new requirements and present feasible steps that your company can take to address gaps in your strategy and to ensure full compliance.

Takeaways

• New regulations require that all medical devices have a CER and PMCF process.
• Ways your company can prepare:
• Compile clinical data and have a plan, policy and procedures in-place to address this requirement
• Conduct a gap analysis
• Enlist experts for guidance or project support