May 2, 2024

IVDR in Focus: Tips for Performance Evaluation Planning to Support Your Transition from IVDD to IVDR

While the concept of a “performance evaluation” hasn’t changed much over the past two decades, IVDR requirements regarding the amount and extent of technical documentation have significantly changed compared to the IVDD. Annex XIII of the IVDR specifies the contents of two new documents: the performance evaluation plan (PEP) and the performance evaluation report (PER).

To help manufacturers prepare and comply with the IVDR, we have compiled some tips for developing and implementing a successful PEP as you prepare for your IVDR submissions.

Learning Objectives: 

  • Describe the scope and objectives of the PEP, including considerations to identify the clinical claims, the target population, the clinical conditions, the comparators, and the endpoints.
  • Review how to conduct a comprehensive systematic literature review, a critical component of the PEP which provides the basis for the clinical evidence, both favorable and unfavorable.
  • Discuss strategies to prepare a detailed scientific validity report (SVR), a new requirement under the IVDR to provide a clear rationale and scientific justification for the choice of the analyte or marker, as well as the evidence of its association with the clinical condition or physiological state.
  • Define the requirements of the analytical performance report (APR), another new requirement under the IVDR which seeks to demonstrate the analytical performance of the IVD in terms of its ability to correctly measure the analyte or marker.
  • Clarify the expectations for sufficient clinical data contained within the clinical performance report (CPR), a key requirement under the IVDR that demonstrates the clinical performance of the IVD in terms of its ability to correctly identify or predict the clinical condition or physiological state of the target population
Click here to reserve your spot for the webinar.

Who is this webinar for?

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

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June 23, 2023

It’s All Interconnected: Hidden Traps That Can Derail Your PER

With the implementation of IVDR requirements, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. In this practical presentation, Criterion Edge uncovers what we have learned from our experience in writing MDR-compliant CERs, and how urgently applicable some of these key learnings are in preparing a robust Performance Evaluation Report (PER).  

This presentation provides practical tips on how to assess for hidden traps and unexpected roadblocks that could impact the success of writing an IVDR-compliant PER. By performing a gap analysis and assessing the readiness and availability of critical resources, documents and expertise, you will be able to avoid project delays and discover efficiencies that will enable the on-time completion of a successful, IVDR-compliant PER. 

Learning Objectives: 

  • The importance of scoping your PER project in advance  
  • The critical inputs needed to enable the success of your PER and the impact to the project if these inputs are not available or incomplete  
  • How to identify those hidden gaps in resources and information and the steps to take to mitigate them

Click here to watch the webinar recording and download the presentation slides.

Who is this webinar for?

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

Ask the Expert: Plain Language Written Content for Multiple Audiences: Effective Communication for Patients, Caregivers, and HCPs

Healthcare companies continually strive to communicate important information about their drugs and devices to diverse audiences comprised of patients, caregivers, healthcare professionals (HCPs), and the general public. The use of plain language written content ensures key health information and clinical research findings are understandable and accessible to all.

Click here to watch this recent webinar to learn key elements of plain language written content, how to identify the target audience, selecting the most appropriate dissemination channels for the information, the challenges to produce a multitude of plain language written deliverables for multiple audiences, and more.

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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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June 27, 2022

ATE: The Role of RA in the Clinical and Performance Evaluation Process

Ask the Expert: The Role of Regulatory Affairs in the Clinical and Performance Evaluation Process

Regulatory Affairs is poised to play a critical role in supporting the current MDR and IVDR required clinical and performance evaluation process, from project implementation through report writing and finally, the on-time submission to the notified body. In this session, we answer questions from many stages of the writing process, from the early planning stage through completion of all required written deliverables. Topics include early assessment of data sufficiency, equivalence considerations, internal readiness of critical documentation, project planning strategies, or how to identify potential roadblocks and proactively find solutions to common problems.

Click here to watch the recording of this session.

Who should watch this session?

Those Regulatory, Quality and Clinical leaders and teams who develop, write, review, or approve clinical evaluation reports for MDR submissions or performance evaluation reports for IVDR submissions.

Thinking about using an outsourced regulatory writing team, but aren’t sure of the advantages?

In today’s medical device and pharmaceutical environment, it’s imperative to analyze and present complex information clearly and concisely while meeting critical timelines. Partnering with team of experienced regulatory writers can be a beneficial alternative to maintaining an in-house writing staff.

Read our blog post to help decide if outsourcing is the right decision for your team.

Key Strategies to Support Project Success for the Clinical and Performance Evaluation Process

Do you know how to identify meaningful safety and performance endpoints (measures/objectives)? Are you confidently able to demonstrate that your safety and performance objectives are appropriate and clinically relevant?

Download our free white paper, 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. It will also help 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.

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