March 30, 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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March 2, 2022

IVD Deep Dive Series Part 1

Safety & Performance Objectives and Acceptance Criteria

How do I define acceptance criteria and how do I define safety and performance objectives?
What are the biggest pitfalls or “Achille’s heels” to watch out for in identifying safety and performance measures?

In this webinar, we’ll take a deep dive into the best practices to identify relevant and appropriate Safety and Performance Objectives and Acceptance Criteria for your Performance Evaluation Report (PER). First, using a case study example, we’ll discuss considerations and provide tips to help you select relevant Safety & Performance Objectives for your IVD. Additionally, we’ll discuss how these objectives relate to the competitive landscape and State-of-the-Art (SOA) section of your PER. Then we’ll explain how these objectives help establish Acceptance Criteria, a critical input for establishing the SOA in your PER.

Watch the webinar recording.

Who should watch this webinar?

Those Regulatory, Quality and Clinical leaders and teams who develop, write, review, or approve performance evaluation 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 23, 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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February 9, 2022

[Ask the Expert] Safety and Performance (MDR)

This session’s topic: Safety and Performance Measures and Acceptance Criteria for MDR

Do you have questions about how to identify meaningful safety and performance measures for the clinical evaluation? What are the best strategies for the verification of device safety and performance? Are you demonstrating that your safety and performance objectives are appropriate and clinically relevant​? Do you know how to specify acceptance criteria that are used to determine the acceptability of benefit-risk?

This is a 45-minute Q&A session during which President Laurie Mitchell will answer questions like these and more. Submit your questions when you register for this forum. Please be aware that answers will be limited to 3 minutes per questions. This forum will operate on a first come first serve basis.

Who is this forum for?

Those Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve Clinical Evaluation Reports for EU MDR submissions

Click here to watch the recording.

Clearly Defining Measurable Safety and Performance Endpoints

The newest regulations for medical devices, Medical Device Regulation (MDR) 2017/745 and MEDDEV 2.7/1 revision 4, set high standards for confirming safety and performance according to the manufacturer’s Instructions for Use. Previously, regulations under the old MDR and MEDDEV were not as demanding. Also, manufacturers are not accustomed to the current systematic process of CER evaluations.  

These relatively new requirements for clinical evaluation extend to manufacturers sending new products into the European market. Additionally, those that are already selling medical devices will have to follow these new requirements. Safety and performance are central components of the evidence-based evaluation process for obtaining and maintaining CE Marking for MDR 2017/745 and MEDDEV 2.7/1 rev 4. Consequently, medical device manufacturers felt the pressure to comply by May 2021.

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

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January 26, 2022

[Ask the Expert] Safety & Performance (IVDR)

This session’s topic: Safety and Performance Objectives and Acceptance Criteria for IVDR

Do you have questions about how to establish meaningful safety and performance measures for the performance evaluation? What are the best methods and practices for identifying acceptance criteria? Are you demonstrating that your safety and performance objectives are appropriate and clinically relevant​?

During this 45-minute Q&A session, our experts answer commonly asked questions like these and more. 

Who should watch the recording?

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

Click here to watch the recording of this webinar and get answers to commonly asked questions before the IVDR date of application.

IVDR Compliance: Insights Gained from Writing MDR-Compliant CERs that Can Be Leveraged to Meet IVDR Requirements

In vitro diagnostic (IVD) medical device manufacturers are scrambling to meet the In Vitro Diagnostic Regulation (IVDR) 2017/746 requirements imposed by the European Union (EU). Changes in IVD classification require the majority of IVDs currently marketed in the EU to undergo notified body scrutiny under IVDR and obtain CE marking, yet few guidance documents have been released. Lessons learned from meeting Medical Device Regulation (MDR) 2017/745 can help pave the way.

One thing is clear, if you have not yet started, time is running out. The May 26, 2022 Date of Application is a hard deadline. Applicable IVDs that are not certified under the IVDR by this deadline cannot be sold on the EU market.  Read our 5 tips to successfully meet the IVDR deadline here.

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