After completing a three-module course about how to write a Clinical Evaluation Report (CER) from the new Medical Device Regulation perspective, I realised there were many things about the topic that I thought I knew but I didn’t. I’m going to share some of them with you, hoping that they’re useful if you want to specialise in writing for medical devices.
Below you’ll find some common FAQ so that you have a quick glossary at hand.
The Clinical Evaluation Report (CER) is a document containing clinical data about a medical device. This data must be collected, appraised, and analysed in a structured way. After completion, a CER is reviewed by the Notified Body (NB), before the device is granted initial or renewal market approval (the CE-mark).
Adapted from: Pritchard G. Clinical evaluation reports from the medical writer’s perspective! Med Writ. 2017;26(2):14–9.
The Medical Device Regulation (MDR) is a European Union law about medical devices that will be applicable from May 26th, 2021 onwards, replacing the Medical Device Directive (MDD). The MDR focus heavily on the safety and efficacy of medical devices, demanding more clinical data during the whole life-cycle of the marketed products.
A medical device is a product or equipment that is used with a medical purpose but does not achieve that medical purpose primarily by pharmacological, immunological, or metabolic means (although it can be assisted through these means). Some examples of medical devices include tongue depressors, glasses, ultrasound machines, medical software, and coronary stents.
A Notified Body (NB) is an independent certification organisation that provides a conformity assessment under the relevant EU directives or regulations. The NB reviews the device’s Technical File (of which the CER is part of) and issues a Declaration of Conformity if the assessed product meets the requirements.
The CE marking is a proof that the medical devices’ manufacturer complies with the EU regulations for that product. The CE marking is a legal requirement to market any medical device in the EU, and under the new MDR, it has to be renewed at periodic intervals.
So, what should you, my fellow medical writer, know about writing a CER under the new MDR? Here are my top three insights from the online course.
Planning is (almost) everything
Sometimes, I still like to entertain the idea that a “proper” writer simply sits down by their typewriter (or, more realistically, computer) and starts writing, pouring the stories or knowledge from their brain. Then I get frustrated when I can’t do the same. Well, no wonder. Writing is hard work, and it requires persistence, research, and planning!
Even simple blog posts (like this one) are planned, and an important document like the CER needs a careful plan, to ensure all important aspects are covered. The MEDDEV 2.7/1 revision 4 has a section devoted to what they call “Stage 0”, where the scope and plan for the clinical evaluation are defined. After scoping and planning the clinical evaluation, you also have to plan how you’re going to conduct the appraisal of data (the literature review).
This was the most mind-blowing aspect of the course for me. Looking back, I recognise my naïveté, but at the time I remember thinking “Wait, so not only you have to conduct TWO literature searches (one general and one specific for the device), but you have to write a PLAN before you even start?!”
Haha. Now that I have half a foot on the medical devices path, I wonder how it could not be like that. If you start aimlessly looking for information, it will take much longer to find relevant information.
Shift your mindset
There were some students on that course that already had a footing in the medical devices scene, and I learned quite a bit from their questions. Me, being green as grass, had a burning question that I was trying not to ask, but I had to. Not knowing was worse.
So, when I finally mustered enough courage, I blurted: “So, can a medical writer write a CER alone? I mean, a single writer, umm, you know, plan, and write…and…everything?”
Despite my babbling (and accent, but that’s a story for another day), I could make myself understood and got an answer that got me half-sighing of relief, and half-terrified.
Most of the times, you will not write a CER alone, unless you’re an über-writer or something. So that’s a relief. You’ll be part of a team. That’s the part that evokes terrible memories of mandatory group works in secondary school and university. I get slightly terrified at the perspective of facing teamwork, but the truth is, it’s quite enjoyable to have other people working on the same project. You can bounce ideas off each other, overcome obstacles together, and commiserate about a looming deadline.
Working in big projects like a CER is more like running a relay race and less like a marathon. Okay, maybe it’s more like a relay marathon, but the idea is that you’ll have to be a part of a team, and while that has its challenges, the results will be better, and you’ll learn a lot along the way.
To write a CER for medical devices, a medical writer should be aware of the changing regulatory landscape. Some time ago, I wrote a two-part blog post in which I also mentioned the new Medical Devices Regulation. It was supposed to start this year (2020), but it was postponed to May 2021.
There are acronyms to know, extensive documents to read, and a lot to prepare before start writing. It is best to be a part of a team and learn not only by taking courses but also by doing. I learned a lot from the course, but I know I’ll be revisiting my notes when I have a medical devices challenge on my hands.
Now, about you: have you ever written a CER? Did you have the same doubts as me when you started? Leave me a comment below or use the contact form to send me an email, I’d love to hear from you 😊
Acknowledgements: Thanks to Yoon Jung Lee, Pharm.D., for proofreading and comments on a previous version of this text.
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