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, 2020For 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  • Clinical experience: published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalent to the device in question or a similar device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? 

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

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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May 22, 2018

Why is it important to establish state of the art during the clinical evaluation?

The large number of mentions of state of the art throughout MEDDEV 2.7/1 rev 4 provide not only a comprehensive description of the importance, purpose, and role of establishing the state of the art, but also inform on how to incorporate this analysis into the clinical evaluation. The image below summarizes several core roles of this analysis.

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May 9, 2018

How has MEDDEV 2.7/1 rev 4 changed the requirements around State of the Art?

Prior to MEDDEV 2.7/1 rev 4, guidance referred to state of the art only vaguely. MEDDEV 2.7/1 rev 3 requested the discussion of clinical data “in comparison with” and “taking account of” state of the art, and that the clinical literature data cited “reflect current medical practice and the generally acknowledged state of the art technologies”. From a methodological standpoint, this is not much guidance. Thus, methodology, depth, and presentation of the medical background for a device was largely left to one’s interpretation, and thus conducted inconsistently, or, at least, heterogeneously. (more…)

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

Join our President, Laurie Mitchell, on April 29, 2020, at 11AM PST / 2PM EST to align your CER with some key MDR requirements. This live webinar will help you assess your CER and identify possible gaps for mitigation before submission.

Attendees are eligible for a free consultation and scan of their CER (or CER template). Spots are limited – click to register for this free webinar.