More likely, though, you think you are ready to embark on the final stages of the journey to certification and need help putting together the clinical documents. Ideally, you already have an early clinical evaluation of your device from the pre-market phase, but in reality, this is almost never the case.

Understanding where your device is in its development with respect to clinical testing and what steps it has gone through, as well as what the future goals and studies may be, should at least be reflected in the Clinical Development Plan.

One important thing to keep in mind is that documents do not exist in silos and every piece of information you include in your dossier should connect to all the rest. The CER is the cornerstone of your clinical evaluation, the document that brings together all favourable and unfavourable clinical data relevant for your device, presenting that within the context of the state of the art. A good CER should be easy to follow and give a complete picture of what your device is, what it claims to do, who the intended patients are, how they may benefit from your device and what risks they may be exposed to. This should all be done with the support of sufficient clinical data, aiming to show device compliance with the relevant General Safety and Performance Requirements of the MDR. But a good CER cannot exist without a well-thought-out plan for how to collect and analyse all available data, which is why a good CEP is essential to set you on your way to a successful clinical evaluation.