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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February 16, 2022

IVD Deep Dive Series Part 2

Clinical Data Sources: Leveraging Clinical Data in the Clinical Performance Report

In Part 1 of our IVD Deep Dive series, we discussed the importance of selecting meaningful performance objectives and explained how these objectives help establish the acceptance criteria. Part 2 of our series will pick up from there with strategies to identify sources of clinical data for your IVD.

Presented from the point of view of seasoned MDR-compliant CER medical writers, this session will present strategies for the verification of IVD clinical performance in the PER. This presentation should help you identify meaningful and measurable performance measures and identify sources of clinical data to support the Clinical Performance Report (CPR).

Key Takeaways:

  • Discuss the purpose of the CPR and its role as a critical component of the PER
  • Identify sources of clinical data and analyze those data within the context of the
    performance endpoints and acceptance criteria presented in the SVR
  • Demonstrate how to extract, organize, and appraise these data within the CPR

Watch the webinar recording.

Who should watch this webinar?

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


Key Changes in the Regulatory Requirements for In Vitro Diagnostic Devices Marketed in the European Union Under IVDR 2017/746

In vitro diagnostic (IVD) medical devices in the European Union are being held to a higher standard of scrutiny with the introduction of In Vitro Diagnostic Regulation (IVDR) 2017/746 by the European Commission (EC).

Overview of In Vitro Diagnostic Regulation 2017/746 

The implementation of IVDR dramatically changes the regulatory landscape for IVD medical devices. Some of the biggest changes include an expanded definition of IVDs and a new classification of IVDs. Some other changes are the requirement of Unique Device Identification (UDI) on each device, an expansion of the Quality Management System, and the increased need for Notified Body (NB) review.

The transition into IVDR is already underway. Consequently, IVDs marketed in the EU will continue to require a CE Marking certificate. This is necessary to verify that the device meets all the regulatory requirements. Indeed, failure to meet the IVDR deadlines could be very costly to manufacturers. They would either lose their CE Marking or fail to obtain one.

Read more on this topic in our blog post, here.

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February 8, 2022

IVDR Essentials: Performance Evaluation Report – Early Planning and Preparation

IVDR Essentials: Performance Evaluation Report – Early Planning and Preparation

In this webinar, we discuss the importance of scoping to help you identify critical internal documents needed for IVDR-readiness. First, we know a PER has many moving pieces. Accordingly, we’ll present strategies to keep you and your team on track and help assess your own level of preparedness. Next, using our CE Scoping checklist, we will walk through the essential IVDR documents. Additionally, we’ll discuss SOPs, processes, reports, and templates, and explain how each of these fits into the overall process of preparing to write.

Goals for this webinar:

  • Emphasize the importance of scoping
  • Discuss how to develop a checklist
  • Illustrate how scoping may help you identify gaps or missing pieces that could lead to delays or challenges in your PER writing process

Who should watch this webinar?

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.

Click here to watch the recording of this webinar.

Leveraging the MDR Experience for IVDR: Tips for Successful Performance Evaluation and PMS/PMCF Processes

Watch our free webinar where Laurie Mitchell and Caroline Byrd discuss and share key “lessons learned” from their years of experience supporting medical device manufacturers in the transition from MDD to MDR and current IVD companies transition to IVDR compliance. How can the insights gained from the MDR experience support and inform IVD companies as they transition to IVDR?

Key takeaways from the discussion include:

  • Early implementation of structural process change across the organization can empower future success with IVDR submissions to the notified bodies
  • What are the key documents and processes essential for successful alignment with IVDR regulations
  • The importance of understanding the critical role of proactive and ongoing Systematic Literature Review search and screening activities
  • Unexpected roadblocks

Who should watch this webinar?

All regulatory, clinical, and scientific professionals who develop, write, review, or approve scientific manuscripts, reports, presentations, and other forms of communications in the medical device, pharmaceutical, and diagnostics space.

Watch the recording.

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January 25, 2022

[FEATURED] Industry Points To Key Outstanding IVDR Issues As EU Council Greenlights Deadline Extensions

The Council of the EU has followed the European Parliament in rubberstamping the European Commission’s proposal for selected IVDR transition deadline extensions, as expected. Industry has expressed relief, but points to other outstanding IVDR issues that also need urgent EU attention.

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January 18, 2022

[FEATURED] EU Notified Bodies Warn Of Major Obstacles To MDR/IVDR Implementation

TEAM-NB, the EU notified body association, warns of disruption in device supply if critical action is not taken to ease the path to implementation. It says the many new medtech regulatory shifts, guidance documents and structures adopted in 2021 must be augmented.

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