In the world of cinema, the ultimate recognition is the Academy Award.
But what if, just for a moment, we imagined comparing a clinical evaluation to a film?
When could it be considered Oscar-worthy? Let’s find out together in this article!
The screenwriters of clinical evaluation: the right team for a flawless script
Ogni grande film inizia con una sceneggiatura ben scritta. Nel caso della valutazione clinica, il Clinical Evaluation Report (CER) è il copione che deve convincere il pubblico più esigente che ci sia: gli Organismi Notificati (ON). Ma, come in ogni produzione cinematografica di alto livello, non basta avere una vaga idea sul da farsi. Al contrario, per redigere un CER che ben si inserisca all’interno del processo di valutazione clinica, e che dialoghi in maniera coerente con gli altri documenti che accompagnano il dispositivo medico, è necessario un team di esperti non da poco.
In short, a well-constructed report must be based on a thorough systematic literature review that defines the relevant state of the art, and on robust clinical data that provide undeniable evidence of the device’s safety and performance.
Each section of the report must contribute to delivering a clear and consistent message, supported by current and relevant evidence.
If the CER lacks coherence (both within itself and with other documents), is outdated, or relies on weak evidence, the film risks being rejected at first glance—and last-minute edits won’t save it.
That’s why it’s essential for the CER to be written—and ideally even planned during the drafting of the Clinical Evaluation Plan—by experienced medical writers capable of creating a work that withstands the scrutiny of the harshest critics.
The team also includes regulatory and clinical specialists, whose review of the report serves as a crucial additional check.
The protagonists: clinical data
Clinical data—the true stars of the clinical evaluation—must be like Meryl Streep in The Devil Wears Prada: undeniable, influential, and on point.
These are the core pieces of evidence that drive the plot of our CER.
Just as a great actor’s performance evokes strong emotions, a well-presented set of clinical data will make the evaluator’s job easier—and we definitely want them to be very happy.
Order, logic, consistency, and transparency are essential to clearly show what data we have, how they were collected, or why they weren’t collected.
The stronger and more solid our data, the more likely they’ll deliver a Meryl Streep-level performance. And if our production doesn’t allow us to cast the queen of acting, no worries! Even amateur actors can be promising.
If there are any “weaker” evidence, it’s necessary to provide context, justification, and solid rationale to support the clinical strategies adopted.
As long as the evidence is sufficient to demonstrate the device’s safety and performance, our CER will have a fair shot at competing for the Oscar.
La premiere: il verdetto dell’organismo notificato
Just like an actor eagerly awaits the Academy Awards, the medical device manufacturer anxiously awaits the verdict on their clinical evaluation.
Receiving CE certification from the NB allows the manufacturer to continue marketing the device—or, in some cases, to launch it.
The importance of having a solid script and the right cast becomes clear at this moment: the higher the quality of the clinical evaluation, the greater the chance of winning the iconic statuette.
And if it doesn’t happen on the first try, as Leonardo DiCaprio taught us, hope is not lost.
In the case of a conditional opinion, the manufacturer will need to address any objections (or non-conformities) and revise the documents as required.
In such cases, having involved expert screenwriters will be a huge advantage.
Just like an Oscar is a major achievement for an actor, obtaining conformity is certainly a significant milestone—but not the final destination.
In fact, the medical device manufacturer must ensure compliance with all obligations set forth by current regulations, including, for example, the requirement to collect data during the post-market phase.
Conclusion
Just like top-tier films, drafting a high-quality clinical evaluation requires careful planning, organization, and the selection of noteworthy screenwriters and protagonists.
Given the wide range of skills required, having expert support not only increases the chances of winning an Oscar—but also of doing so in just a few “lights, camera, action!”
