Clinical Evaluation Report Templates

The dangers of using a Clinical Evaluation Report Template, example or sample — no substitute for knowledge.

What is a Clinical Evaluation Report?

A Clinical Evaluation Report (CER) is a complex technical document that summarises the process of Clinical Evaluation, required as a component of all medical device regulatory submissions under the MDR. In turn, Clinical Evaluation is a structured assessment of clinical data to determine whether a medical device is safe and performs as it should do.

The introduction of the Medical Device Regulations (MDR), in full force from May 2021, means that Clinical Evaluation Reports will need to be written to a higher standard than ever before, incorporating and accurately summarising all elements of the broader Clinical Evaluation process required by the MDR. CER writing has become a very demanding and highly technical task that draws upon skills and experience that are not universally available across the medical device industry.

For this reason, many manufacturers are tempted to rely on a CER Template, example, or sample, hoping that this will allow them to develop a CER to the required standard without needing to draw upon external expertise.

The dangers of relying on a Clinical Evaluation Report Template or example

Under the MDR, the very nature of a Clinical Evaluation Report is that it is unique and highly tailored to the medical device in question. The MDR is structured in such a way that the Clinical Evaluation of every device will be unlike that of almost any other.

Therefore, relying on a Clinical Evaluation Report Template or example is unlikely to yield sufficient flexibility to capture the unique requirements of Clinical Evaluation of any individual device. Furthermore, Clinical Evaluation requires a high degree of clinical interpretation and appraisal that no template or written document can be a substitute for. A external, pre-written CER plan is similarly unlikely to be helpful due to its inherent inflexibility and inability to account for the variability of devices in the market.

Reasons for Clinical Evaluation variability between devices include:

  • Annex I General Safety and Performance Requirements. The Annex I GSPRs are a comprehensive list of requirements, some (but not all) of which will relate to a particular device. Because each Requirement will need a dedicated piece of evidence to demonstrate conformity, it will be impossible to find a Clinical Evaluation Report Template that is flexible enough to account for the huge number of possible permutations.
  • Device risk classification. Annex VIII MDR defines four risk classes of medical device - Class I, IIa, IIb and III. Clinical Evaluation is markedly different in each risk class, meaning that a Clinical Evaluation Report Template or example will be unlikely to properly address the unique requirements for each individual risk class.
  • Unique clinical evidence portfolios. The clinical evidence portfolio for one device will seldom be similar to that of another. How can a Clinical Evaluation Report Template enable a writer to draft an accurate summary of every individual piece of clinical evidence, as required by MDR, in the absence of sufficient clinical skill and knowledge?
  • Vigilance and PMCF findings. An MDR requirement is to compile and clinically interpret the findings of Vigilance and Post-Market Clinical Follow-up (PMCF) systems, and to summarise this interpretation in the Clinical Evaluation Report. This process requires the writer to have sufficient clinical knowledge and acumen to perform such an interpretation. It is difficult to see how a Clinical Evaluation Report Template could compensate for any absence of these skills and capabilities.

In summary, a CER Template will not be reliable because it cannot be sufficiently flexible to accommodate for the range of variability imposed by the MDR. Furthermore, the output from the template is a function of both the quality of the template itself and the skill of the person applying it, meaning that a level of skill and experience is still required in order to successfully apply even the very best template.

If a manufacturer is tempted to rely on a CER Template or example, it may be a sign that further development of relevant knowledge and skill is required.

Can Mantra Systems help you?

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What are the alternatives to using a Clinical Evaluation Report Template?

A fundamental principle of successfully working with the MDR is to directly address any areas of deficiency rather than trying to work around them. This applies both to medical devices themselves, and to individuals working to support regulatory approval of medical devices.

If you are a manufacturer who is tempted to rely on a Clinical Evaluation Report Template, a wise investment would be to directly address any knowledge gaps in your team, and/or engage specialist services to ensure that your CERs are produced to the required standard.

Undertaking appropriate training to better understand MDR requirements for Clinical Evaluation and CERs is an investment that is likely to pay for itself through enabling your team members.

Alternatively, working directly with a specialist who has the necessary skill set and professional capabilities will ensure that your CERs are completed quickly and to a professional standard that meets or exceeds all MDR requirements.

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