Clinical Evaluation

Working with scientific writers on clinical evaluation reports (CERs)

Clinical evaluation is ongoing and necessary for medical device manufacturers. A manufacturer that sells its products in Europe must comply with increased clinical data requirements and ongoing clinical evaluation. The purpose of periodic clinical evaluation is to provide systematic demonstration of medical device safety and performance throughout the lifespan of the device. Medical device manufacturers can fulfill clinical evaluation requirements by making use of information from several data sources including premarket clinical studies, evidence from the literature, compliance with standards, complaints reporting, and data generated from post market activities, including data from postmarket clinical follow-up studies.

Due to the significant amount of effort required to assemble, summarize, and synthesize all of this information into a clinical evaluation report (CER), along with the continual need for updated CERs, many manufacturers are outsourcing CER writing to qualified scientific writers. If you plan to work with an outside writer, there are things you can do to ensure a smooth (and thus cost-effective) process. Ahead of time, gather all of the necessary information to share, but don’t expect a completely hands-off experience. Plan to educate the writer on the device, indications for use, and typical commercial usage.  The scope of the CER (i.e., which devices are included, the extent of information to be gathered, the methods that will be used to examine the qualitative and quantitative aspects of clinical safety, and the date range the CER will cover) should be documented prospectively in the Clinical Evaluation Plan. Device- and indication-related terminology should also be discussed to assist in accurate and comprehensive searches of available literature. A qualified scientific writer may draft the entire CER or you may elect to have your writer draft only the literature-based sections of the CER.

A CER is meant to examine the risks and benefits of a device and thus must include a summary of the medical background and current relevant state of the art, information characterizing the safety or performance of the device that is generated from actual use of the device, and a risk evaluation. It will typically include:

  • Device classification and regulatory history, including any recalls;
  • Intended use of the device and any special indications or target populations;
  • Device description including design features, names, models, and sizes;
  • High level summary of non-clinical data;
  • Sales figures and complaints reported within the time period being examined;
  • Clinical background and review of the current state of the art (including risks and benefits of alternative therapies);
  • Information needed for demonstrating equivalence (new devices only);
  • Clinical data related to use of the device in published literature;
  • Clinical data from unpublished clinical studies in possession of the manufacturer;
  • Clinical data generated from postmarket surveillance;
  • Risk evaluation, including identified risks, mitigations, and residual risks; and
  • Conclusions regarding the risks versus benefits of the device(s).

Be sure your scientific writer plans and applies a literature search strategy that is thorough and documented in detail so that search results can be independently replicated. Selection of literature should be objective and justifiable. Plan to discuss the literature search results for relevance, and make sure the writer knows to pass along any reports of off-label use or reportable adverse events, even if they do not meet the criteria for inclusion in the CER. Once determined in-scope, literature search results are subjected to a defined appraisal process to determine their contribution to the overall clinical evaluation. Before you jump into collection, appraisal and analysis of published clinical data, be aware that there are specific guidelines defining who can take on this task. Regulators want to know that the individuals evaluating clinical data are well qualified to do so. Reviewer qualifications must be documented and include (but are not limited to) knowledge of research methodology, regulations, medical writing, application of the specific technology, and diagnosis and management of the conditions to be diagnosed or managed by the device under evaluation.

We are qualified clinical evidence report writers and have the experience and appropriate skill set to appraise and weigh available clinical data and expertly develop your CER to help meet the current EU MDR. Please contact us today to get started on your path to compliance 855.463.1633 | askmed@medinstitute.com | medinstitute.com.

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