November 12, 2020

[FREE WEBINAR] Hidden Traps That Derail PER Preparedness: Lessons Learned from the MDR-Compliant CER Writing Experience

Get a copy of the slides from this webinar or click to watch the recording.

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). 

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 Performance Evaluation Reports for EU IVDR submission, or anyone interested in learning more about IVDR requirements for PERs. 

Sign up for future webinars here.


Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?

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October 22, 2020

[FREE WEBINAR] Hidden Traps That Will Derail Your CER: Answer these critical questions before you start writing

Get a copy of the slides from this webinar or click to watch the recording.

You have planned a time to complete your Clinical Evaluation Reports to meet the upcoming MDR deadline, but when your team sits down to write, will they have everything they need to complete the job?

As we all know, the MDR has significantly increased both the quality and quantity of inputs needed to complete a CER. This takes more up-front planning than the reports have in the past, and the last thing you want to do is torpedo your writing project timeline by not having everything your team needs when that project begins.

Based on our experiences with clients both large and small, our President, Laurie Mitchell, will share with you some of the biggest issues we have discovered when starting an MDR CER project. And Laurie will also reveal some of the most successful strategies in addressing these issues, up-front and early.

Sign up for future webinars here.


Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?

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September 16, 2020

[FREE WEBINAR] A Practical Guide: Conducting Systematic Literature Reviews in Support of IVDR Readiness

Get a copy of the slides from this webinar or click to watch the recording.

With the implementation of IVDR requirements, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. Companies realize the need to review published literature for device-specific clinical data to establish the state of the art (scientific validity) and clinical performance of their products, however many manufacturers may not be familiar with or have the capability to perform rigorous, IVDR-compliant systematic literature reviews (SLR), screening, selection and data extraction.

In this practical presentation, Criterion Edge breaks down the steps of the SLR process and takes a wholistic approach to conducting an IVDR-compliant SLR. Using case studies, the presentation illustrates the effective use of SLR-derived data to develop the Scientific Validity Report (SVR) and the Clinical Performance Report (CPR).

Key Takeaways:
• Review the essential steps for conducting a robust, methodologically-sound systematic literature review

• Using a typical case study scenario, learn how to effectively search, identify, screen, review and extract critical published clinical data on your subject IVD device to support the development of the Scientific Validity and Clinical Performance Reports.

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 Performance Evaluation Reports for EU IVDR submission, or anyone interested in learning more about IVDR requirements for PERs.

Sign up for future webinars here.


If you enjoyed this webinar and would like a free consultation, please contact us here.

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June 5, 2020

[FREE WEBINAR] Live Q&A Follow-Up: How to Assess Your CER for MDR Readiness, Part 1

Q&A Follow Up with Laurie

Click here to watch the recording.

We had such a large turnout at our previous webinar, How to Assess Your CER for MDR Readiness, Part 1, and left with some questions unanswered. Therefore, President Laurie Mitchell held a live Q&A to respond to questions regarding CER for MDR Readiness. In this webinar, Laurie delves deeper into some of your pressing questions like:

  • Would you recommend using clinical data from systematic reviews and meta-analyses to support the safety and performance of the subject device? 
  • Do you compare warnings and precautions as part of clinical equivalence? 
  • Can you give an example of a safety/performance objective and corresponding acceptance criteria?  

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.

Sign up for future webinars here.


If you enjoyed this webinar and would like a free consultation, please contact us here.

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March 10, 2020

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)?

Author: Suzanne Broussard

Checking off list on time

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: This includes missing elementary requirements of the clinical evaluation such as methods, results of clinical studies, observed undesirable side effects, and details on the intend-to-treat population.
  2. Numbers too small for statistical significance: This may include publications and reports with “inconclusive preliminary data, inconclusive data from feasibility studies, anecdotal experience, hypothesis papers and unsubscribed opinions.”
  3. Improper statistical methods: The examples given are centered around 3 scenarios. 1) No corrections applied to multiple comparisons. 2) Calculations and test were used that are based on a certain type of distribution data while the distribution is not tested, not plausible, or data were not transformed.
  4. Lack of adequate controls: It is possible to cause bias or confounding in single arm-studies and in other studies that do not include appropriate controls in the following situations: results based on subjective endpoint assessments, endpoints subject to natural fluctuations, studies with subjects that are likely to take effective co-interventions, other influencing factors, or when publications indicate there may be variables and ill controlled factors.
  5. Improper collection of mortality and serious adverse events data: In situations where mortality studies and other studies that may result in serious outcomes, there must be procedures in place to “investigate serious patient outcomes, numbers of subjects lost to follow-up, reasons why subjects leave the study, and the results of sensitivity analysis should be fully disclosed in reports and publications.”
  6. Misinterpretation by the authors: Conclusions must be in line with the results section.
  7. Illegal activities: All clinical investigations must be in compliance with local regulations, as well as designed, conducted, and reported in accordance with EN ISO 14155 or a comparable standard, and the Declaration of Helsinki.

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

The first deficiency listed, “lack of information on elementary aspects,” can obviously be improved using a robust systematic literature review. Defining the evaluation criteria is the first step in performing a methodologically sound systematic literature review, and these sections would then fall into place. For example, one criterion would define the clinical study methods, while other criteria might include clearly defining results to be included, undesirable side effects, and the intended-to-treat population. A scientifically sound approach and well-organized data management plan can bring all the clinical data together and allow for a thorough understanding of where the device is in the process of obtaining an CE marking.

Less obvious is how a methodologically sound systematic literature review can help with some of the other CER deficiencies. Let’s look at the three points in a devices lifecycle in which clinical evaluation is undertaken: development of the medical device (section 6.2.1), initial CE-marking (section 6.2.2), and updating the clinical evaluation (section 6.2.3).

The systematic literature review can be an effective tool early in the development of the medical device for gap analysis and determining State-of-the-Art. Once all the clinical evidence is gathered it is much easier to see if the publications and report documents have conclusive preliminary data or if further clinical data is required before moving forward with CER submissions. And, closely evaluating the complied data makes it easier for manufacturers to note statistical methods in the supporting data, and the potential of bias.

Of course, not all inadequacies can be addressed with a systematic literature review, such as improper collection of mortality and serious events data that rely on a different process for review. It is always important to collaborate with your organization’s regulatory authorities or a regulatory specialist to make sure you are complying in these areas.

Following leading practices and presenting clinical data in a straight-forward manner helps manufacturers be in good position to help regulatory agencies not to have to say No to your CER submission. Lack of organization and transparency can create a cycle of generating responses to regulatory agencies and delays getting devices to market.

Systematic literature reviews can help you find gaps in information that may be needed for inclusion in the CER, as well as putting your best foot forward by strongly providing sufficient clinical evidence for the evaluation of safety and performance of the device. Regulatory agencies expect this level of compliance. We can help you meet the challenge. We are experts in this area. Check out our recent webinars to better understand the process.

Systematic Literature Review to Help Meet MDR Requirements

Systematic Literature Review to Empower Data-Driven Decision-Making


At Criterion Edge, we are experts at generating methodologically sound systematic literature reviews and state-of-the-art reports to ensure your CER is ready for review by notified bodies. And, we can help ensure the scientific validity is adequate and document the methods we use for data collection. Talk to us about running a systematic literature review for you. 

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