Critical Concepts: A Deep Dive into MDR and IVDR Device Classification and Data Collection Strategies

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, our regulatory experts 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

Who is this webinar for? 

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 or performance evaluation reports for IVDR submissions.

November 2nd, 2022 Watch at a Convenient Time Recorded

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To watch the free webinar recording, Critical Concepts: A Deep Dive into MDR and IVDR Device Classification and Data Collection Strategies, fill out the form below.


Takeaways from this session:

  • Gain insights into the potential impact of risk-based classifications
  • Learn data collection strategies to support data sufficiency in the CER and PER
  • And more!
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