[FREE WEBINAR] Critical Concepts: A Deep Dive into MDR and IVDR Device Classification and Data Collection Strategies

Click here to watch the recording of this webinar.

In September 2022, European Commissioners published updates to the Manual on Borderline and Classification for Medical Devices, which provides clarifications for classifying devices as medical or in vitro diagnostic devices under the MDR and IVDR. This guidance describes how to distinguish medical devices from medicinal products, biocides, and personal protective equipment, and how to distinguish between in vitro diagnostic medical devices and general laboratory equipment.

In this “Critical Concepts” webinar, we discuss rules for device classification under each regulation, as well as the risk-based classification rules as described in MDCH 2021-24 and MDCG 2020-16.

Key Takeaways

  • Learn the potential impact of risk-based classifications on your data collection strategies
  • Understand how to support data sufficiency in the CER and PER
  • Gain best-practice strategies for device classification

Who Should Watch?

Those Regulatory, Quality, and Clinical leaders and teams who are tasked with the development, writing, review, or approval of clinical evaluation reports for MDR submissions.  

Who are the Panelists?

President Laurie Mitchell 

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