Clinical and Performance Evaluation Under EU-MDR: New CE Mark Rules
The impending EU Medical Device Regulation (EU-MDR) and its companion In Vitro Diagnostic Regulation (IVDR) are raising the bar for demonstrating the safety and performance to obtain or maintain the critical CE mark necessary to market products in the EU.
Notified bodies (NB) are now more strictly enforcing clinical and performance evaluation requirements. You must learn how to prepare the strongest — most convincing — clinical evaluation and performance evaluation reports for your CE mark submissions.
Many device and diagnostics companies are performing these evaluations for the first time or are struggling to understand the NBs’ raised expectations
Clinical and Performance Evaluation Under EU-MDR: New CE Mark Rules outlines the new requirements and provides details on how to perform the necessary evaluations and prepare the resulting reports. It describes common pitfalls companies face in making their case to NBs and offers recommendations for sidestepping them.
You will learn about the three pillars of performance evaluation, the level or clinical evidence required for a CE mark, how clinical evaluations can be leveraged to produce stronger performance evaluation reports, how to conduct postmarket clinical follow-ups and more.
Management Report Takeaways Include:
- EU-MDR requirements for clinical evaluations and IVDR requirements for performance evaluations, including what plans and reports are needed for these evaluations
- Ideas for the recommended structure of the reports, such as what sections are required for each type of evaluation and the type of data that goes in each section
- How literature searches can be used within these evaluations
- Strategies for overcoming common NB findings and pitfalls, including properly justifying equivalence and data presentation
Clinical and Performance Evaluation Under EU-MDR will guide you to a deeper understanding of what your company must do to meet the EU-MDR and EU-IVDR requirements and how to manage any necessary adjustments.
Ensure your CE mark success. Order your copy today.
Who Will Benefit
- Quality manager
- Regulatory manager
- Submissions manager
- Design manager
- Technical manager
- Clinical manager
- Authorized representative in Europe
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