November 5, 2022

[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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October 31, 2022

[FREE WEBINAR] Critical Concepts: The Role of Post Market Activities in Establishing Data Sufficiency

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In this webinar, we review the conformity requirements for legacy devices under the MDR and established devices under the IVDR to help you harness the potential of effective post market activities.

We discuss how legacy devices, defined as those previously certified under MDD/AIMDD, can demonstrate conformity to the general safety and performance requirements under the MDR through a collection of pre-market and post-market data. 

Key Takeaways

  • Learn which types of clinical data are appropriate to use for legacy devices
  • How to effectively identify, present and analyze clinical data for both MDR and IVDR requirements
  • Understand the MDCG 2020-6 guidance on clinical data for legacy devices

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 IVDR or MDR submissions.  

Who are the Panelists?

Stacie Beecham and Dr. Sarah Chavez

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September 30, 2022

[FREE WEBINAR] CER Critical Concepts: Effectively Telling the Story of the CER – Focus on S&P Objectives, Acceptance Criteria, Clinical Benefits and Risk-Benefit Analysis

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Presented from the point of view of seasoned MDR-compliant CER medical writers, this session takes a practical approach to define safety and performance objectives, clinical outcomes, clinical benefits, acceptance criteria, and risk-benefit ratio related to the CER. Our experts discuss how to develop MDR-aligned safety and performance objectives, how clinical outcomes are leveraged, and tie it all together in the Risk-Benefit section of the CER.

Key Takeaways

  • How to effectively identify, present and analyze CER parameters
  • Understand how clinical outcomes differentiate from S&P objectives
  • Learn how these key foundational concepts “tell the story” of the CER

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 

Sign up for future webinars here.


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September 16, 2022

CER Critical Concepts

Clinical Evaluation Report Critical Concepts: Effectively Telling the Story of the CER – Focus on S&P Objectives, Acceptance Criteria, Clinical Benefits and Risk-Benefit Analysis

Safety and performance objectives…..clinical outcomes…..clinical benefits…..acceptance criteria…..risk-benefit ratio. These terms represent key concepts of the Clinical Evaluation Report (CER), yet confusion still exists on how to effectively identify, present and analyze these parameters within the context of an MDR-compliant CER. How do they tie together? How do they help you “tell the story” of the CER?

Click here to watch the recording of this session.

Presented from the point of view of seasoned MDR-compliant CER medical writers, this session will take a practical approach to:

  • Define each of these concepts and their relationship to each other
  • Develop MDR-aligned safety and performance objectives
  • How clinical outcomes are leveraged in the CER and how they are different from S&P objectives
  • Tying it all together in the Risk-Benefit section of the CER (hint: this section is where it all comes together)

There will be time at the end of this session to ask questions. Please submit your questions ahead of time while registering for this session so we have ample time to answer them thoughtfully. You may choose to send in your questions during the presentation as well.

Who is this forum for?

Those Regulatory, Quality and Clinical leaders and teams who develop, write, review, or approve clinical evaluation reports for MDR submissions. Anyone interested in learning more about MDR requirements for CERs is also welcome to attend. Also, we encourage professionals from the IVD industry to attend as well, as the content is also relevant to IVDR requirements, which align closely with MDR.

Critical Concepts: Measurable Objectives and Acceptance Criteria

This white paper is a companion piece to our popular webinar where we cover strategies to verify device safety and performance in the clinical evaluation of medical and in vitro diagnostic (IVDs) devices. This white paper should help you with identifying meaningful safety and performance measures for clinical or performance evaluation and with defining acceptance criteria parameters to determine the acceptability of benefit-risk as mandated by Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746.

Establishing your device’s safety and performance is a critical component of the clinical evaluation process. However, how to use the state of the art section within the Clinical Evaluation Report (CER) and Performance Evaluation Report (PER) to establish the device’s safety and performance objectives and acceptance criteria can seem ambiguous.

Download the full white paper here.

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