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Connecting the DotsThe Criterion Edge Blog

January 19, 2022

Post-Market Literature Surveillance: Systematic Literature Review and Case Study

by CE_Writers on January 19, 2022
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Post-Market Literature Surveillance: Systematic Literature Review and Case Study Webinar

Joining Criterion Edge’s President Laurie Mitchell, is our guest speaker, Queenita Fernandes, Medtronic’s Medical Safety Manager, Patient Monitoring & Respiratory Interventions​. In this webinar, we will discuss how to deploy systematic literature review in order to augment post-market clinical surveillance, and share our best tips on a robust systematic literature review process. Following this, our guest speaker will share an informative case study illustrating more.

Who should watch this webinar?

Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Clinical Evaluation Reports for EU MDR submission, or anyone interested in learning more about MDR requirements for CERs.

Click here to watch the webinar recording.

How Can a Systematic Literature Review (SLR) Help Prevent Common Pitfalls in Meeting the Elementary Requirements of Clinical Evaluation for MEDDEV 2.7/1 revision 4 Clinical Evaluation Report (CER)?

Performing a methodologically sound literature review in the early stages of product development, as well as in the later stages, can help reduce most of the inadequacies highlighted by the European Commission in section A6 of MEDDEV 2.7/1 revision 4.  Section A6 provides examples of studies that lack scientific validity for the demonstration of adequate clinical performance and/or safety.

Here are the seven areas highlighted in section A6 of MEDDEV 2.7/1 revision 4 that manufacturers tend to have the most problems in proving scientific validity:

  1. Lack of information on elementary aspects
  2. Numbers too small for statistical significance
  3. Improper statistical methods
  4. Lack of adequate controls
  5. Improper collection of mortality and serious adverse events data
  6. Misinterpretation by the authors
  7. Illegal activities

Read more about the implications of these problems and how to improve in our blog post, here.

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June 15, 2020

New Guidance Templates for the Post-Market Clinical Follow-Up (PMCF) Plan and PMCF Evaluation Report

by CE_Writers on June 15, 2020
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Author: Suzanne Broussard

The newest guidance documents for post-market clinical follow-up (PMCF) requirements have just been released by the Medical Device Coordination Group (MDCG). The two documents provide guidance templates for the PMCF plan and the PMCF evaluation report to help manufacturers meet the stricter regulatory requirements under Medical Device Regulation (MDR) 2017/745.  

Here are the links to the 2 newest PMCF guidance documents: 

MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies 

MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies  

These templates should help manufacturers understand more clearly what needs to be included in the PMCF as well as present the information in a harmonized manner. Indeed, these templates provide guidance on the presentation of post-market clinical data to assist notified bodies and competent authorities find information in an organized format.   

 The PMCF plan template provides a clear outline of the PMCF plan in Sections A through G. The intent is that PMCF is a continuous process designed to “proactively collect and evaluate clinical data from use in or on humans of a CE marked medical device, placed on the market or put into service within its intended purpose, as referred to in the relevant conformity assessment procedure.” Presenting all this data in an organized, cohesive, and convincing manner just got a little easier thanks to the PMCF document templates. 

The PMCF plan is designed to be implanted and the results documented in the PMCF evaluation report. The link between the 2 is evident by the symmetry in these templates. 

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April 7, 2020

Does Your Organization’s Post-Market Clinical Follow-Up (PMCF) Plan Adequately Reflect the Intensity Required in the Clinical Evaluation Report (CER) Under the Newest Medical Device Regulations?

by CE_Writers on April 7, 2020
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Author: Suzanne Broussard

magnifying glass over documents

Post-market clinical follow-up (PMCF) requirements have increased under the newest Medical Device Regulations (MDR) 2017/745. All medical devices will be required to meet these standards, and the deadline is here. The possible 1-year extension for the application of MDR might give manufacturers a little wiggle room to achieve compliance, but not much. 

The European Commission (EC) states in a nutshell that one of the reasons for the new regulations is to strengthen post-market surveillance requirements for manufacturers. 

The goals for these new regulations are to: 

  • Improve the quality, safety, and reliability of medical devices 
  • Strengthen transparency of information for consumers 
  • Enhance vigilance and market surveillance 

The EC considers these newest regulations as providing extremely important improvements to modernize the current system and, therefore, medical device manufacturers need to make every effort to be compliant or risk further delays in obtaining a CE marking for their device.  

In a recent post, we discussed one of the most challenging areas in the CER: Defining Measurable Safety and Performance Endpoints.

The PMCF plan must establish processes that proactively and systematically collect information from a variety of sources. These sources include serious incidents, Periodic Safety Update Reports (PSUR), field safety corrective actions, inputs on non-serious injury, undesirable side-effects, trend reports, literature, databases, registers, feedback and complaint sources form users, distributers and importers, as well as publicly available information on similar medical devices (MDR 2017/745, Annex III).  

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October 8, 2018

[FEATURED] EU Post-Market Clinical Follow Up: What Manufacturers Need To Know

by CE_Writers on October 8, 2018
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The EU’s new medtech regulations introduce much more comprehensive post-market clinical follow-up requirements for device and diagnostics companies. What do they entail, and why are there problems in understanding what will be required? Consultant Sarah Sorrel offers insights in an interview with Medtech Insight.

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About the Blog

In this blog, we share our insights and experiences to help companies build quality, scalability, and flexibility into their regulatory writing.  We hope you find it insightful. For questions, please contact info@criterionedge.com.

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  • [FEATURED] Against The Odds: Notified Bodies Pinpoint The Real Obstacles And Ways To Move Past Them
  • [FEATURED] Updated: New MDR Notified Body Designations Pending, But Only One Under IVDR Until Late 2022

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    How to Establish the Competitive Landscape Within the Scientific Validity Report

    IVD Deep Dive Series Part 2

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    Schedule a Free Consult Today!

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