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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May 1, 2020

[FREE WEBINAR] How to Assess Your CER for MDR Readiness, Part 1: State of the Art, Safety & Performance Criteria, Equivalence and Systematic Literature Review

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

In this first installment of a 2-part webinar series, Criterion Edge will present strategies for assessing key components of your CER (or CER template) for possible misalignment with significant and applicable MDR requirements. Presented from the perspective of seasoned regulatory writers with deep experience developing MDR compliant CER templates and recent authorship of MDR-ready CERs, this practical presentation will help you assess your document through the critical lens of a writer and identify possible gaps for mitigation before submission to regulatory authorities.

In the second part of this series, we examine the Clinical Data Sources, Equivalence, and Risk/Benefit Analysis Profile sections of the CER.
Click here to get the slides and watch the recording for part 2.

Key Takeaways:
• Identify key MDR requirements that are applicable to critical components of a CER
• Apply review strategies to help evaluate your CER for alignment with MDR requirements
• Why organization, structure and clear language really matter in your CER

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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February 19, 2020

Clearly Defining Measurable Safety and Performance Endpoints in Clinical Evaluation Reports (CER) is a Real Challenge for Medical Device Manufacturers

Author: Suzanne Broussard 

All medical devices sold in Europe must have a Clinical Evaluation Report (CER), and specific and measurable safety and performance endpoints are paramount for an acceptable CER. However, many small medical device manufacturers are struggling to adequately define and subsequently document measurable safety and performance endpoints, especially in the literature review, to support an evidence-based evaluation 

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 when using the device according to the manufacturer’s Instructions for UseRegulations under the old MDR and MEDDEV were not as demanding, and manufacturers are not accustomed to the current systematic process of CER evaluations.  

These relatively new requirements for clinical evaluation extend to manufacturers trying to get new products into the European market, as well as those that are already selling medical devices. 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, and medical device manufacturers are expected to be in full compliance by May 26, 2020*For manufacturers that already have products on the market, the CER must be updated throughout the product lifecycle.  

For more information on the role of CERs in obtaining CE Marking for legal marketing in the European Union (EU), see Criterion Edge’s article What role does the CER play in getting a Medical Device Approved for Marketing in the EU? 

Systematic literature reviews (SLRs) are a big part of the CER. The ultimate goal of the CER is to provide sufficient clinical evidence that the device achieves its intended purpose and is safe and effectiveMEDDEV 2.7/1 rev 4 Section 4 defines evidence-based as: 

  • Clinical studies: clinical data from clinical investigations of the device concerned; or 
  • Existing data: clinical investigation(s) or other studies reported in the scientific literature, or a similar device for which equivalence to the device in question can be demonstrated, or 
  • Clinical experience: published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalent to the device in question or a similar device for which equivalence to the device in question can be demonstrated.  

Note that this list is comprised primarily of endpoints that need to be generated by performing methodologically sound systematic literature reviews.

Clearly setting safety and performance objectives in the review of scientific literature proves to have its own special challenges. Conducting systematic literature reviews requires expertisepeople, and time 

  • The individual or team of evaluators should possess knowledge and expertise of research methodologies (including clinical investigation design and biostatistics), information management, regulatory requirements, and degree and experience equivalence (MEDEV 2.7/1 rev 4 Section 6.4) 
  • It is often difficult to find experienced personnel that meet all the requirements to perform the clinical evaluation. 
  • Performing systematic literature reviews takes time, lots of time! 

A systematic literature review is much different than an internetbased literature review for a scientific manuscript. It requires a clear and methodologically sound search strategy coupled with a robust literature search. Every decision needs to be documented. 

There are many circumstances in which using experts in some areas of CER preparation can fill in gaps where expertise may bneeded, or time is of the essenceTo determine if hiring a consulting expert to facilitate timely and expert CER development, ask your organization these questions. 

Does your team meet all the criteria for preparing the clinical evaluation?  

Does your team know how to document the methods used to generate systematic literature reviews?  

Are they familiar with what aspects to consider when determining relevance? 

Do they have the time to perform systematic literature reviews? 

* MDR deadline has been extended one year to May 26th, 2021

Criterion Edge is an expert at CER preparation, generating a systematic literature review, and determining state of the art of medical devices based on systematic literature reviews. As leaders in this area, we have given 3 webinars for our customers; one we sponsored for the Regulatory Affairs and Professional Society (RAPS) community. These webinars can be accessed on our main page or by following these links:

Systematic Literature Review To Help Meet MDR Requirements

Systematic Literature Review: How to Empower Data-Driven Decision Making 

State of the Art Literature Review for EU MDR Compliance: How to Get It Right 

In addition, our whitepaper State of the Art: Best Practices and Literature Review Using DistillerSR provides detail on how we perform systematic literature reviews and document all processes.  

We share these resources to help medical device manufacturers develop strong CERs with measurable endpoints that ultimately make the review process smoother and get products to market faster.

“These rigorous principles for performing systematic literature reviews are now mandated by global regulatory authorities.”

Laurie Mitchell, President Criterion Edge

At Criterion Edge, we are experts at preparing CERs and can ensure your reports and systematic literature reviews are methodologically sound, and safety and performance are measurable.  Our medical writers are experienced at setting measurable objectives for safety and performance and performing methodologically sound systematic literature reviews. Contact us for more information on how we can help your organization with preparing CERs and systematic literature reviews.  

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November 16, 2018

[FREE WEBINAR] The Art of State of The Art: All You Need to Know

View Criterion Edge’s President, Laurie Mitchell, and Evidence Partners’ President, Peter O’Blenis, for an xTalks webinar on State of the Art Literature Review: How To Get It Right. (recorded: December 11, 2018, 9 AM PST/12pm EST)
Tune in to learn about key components of an effective state of the art description as well as common points of failure in state of the art literature reviews. Peter and Laurie will expand on sound methods and expert tips for completing an effective literature search. They will be covering the best practices to efficiently produce and maintain a fully compliant and audit-ready clinical background/state of the art description using DistillerSR, and addressing any questions or concerns that may arise.

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May 30, 2018

Developing the state of the art section of the CER: challenges and pitfalls

There is no doubt that establishing state of the art is a challenge. It ranges from key information on the medical condition to a neutral, comprehensive analysis of treatment options, and culminates in a succinct yet comprehensive presentation that defines the currently accepted safety and performance standards against which the device is measured. Not surprisingly, common pitfalls include a perspective that is too broad and inclusion of too much detail, or a perspective that is too narrow, omitting relevant indications and alternative therapeutic options. An important critical aspect of the clinical evaluation that relies on state of the art data is also to appropriately define the position of the device within the currently available treatment portfolio.

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