One of the biggest misconceptions about Clinical Evaluation Reports (CERs) is that you only need to think about writing one after all your clinical trial and product study data are in. Not true.
Yes, your CER will eventually need to include your clinical data. But its real purpose is to put your product side-by-side with other products on the market that have the same intended use. Think of it as an apples-to-apples comparison. And the easier you make that comparison for a Notified Body, the smoother your assessment process will be.
This doesn’t mean you can’t eventually expand your claims or your product’s intended use. It just means that you’ll want to anchor your device in what’s already out there — showing, as clearly as possible, that your device is at least as safe and effective as products that have published data.
Here’s the part people often overlook: many sections of the CER can (and should) be developed well before you run a clinical trial. In fact, building out your CER early can help you design a better trial. Your scope, population, study endpoints, and even your risk mitigation strategies can all be informed by what’s uncovered in the CER.
At the heart of the CER is the systematic literature review. This is how you prove to Notified Bodies that you’ve mapped the market landscape and understood what kinds of products, claims, and outcomes are already in play. You want to show that you’ve taken in lessons learned from this review and incorporated your findings into how you’ve designed your device and what outcomes and risks you’ve chosen to follow. On another practical note, knowing how certain outcomes were measured in previous studies is extremely important, as you can then make informed decisions on which metrics to use in the clinical evaluation of your own device (remember: apples to apples comparisons are easier for an NB reviewer).
Similar to the literature review is the equivalent device analysis. Chances are you’ve already done this informally while pitching to investors or planning your market strategy. But formalizing it — and integrating it into your CER — is a huge time-saver. Knowing which equivalent devices are out there and how the claims of these devices were supported can give you invaluable inputs into 1) whether you need to do your own clinical trial, 2) the parameters of the trial once you decide you need one, and 3) risks you should be aware of.
A Clinical Evaluation Report (CER) is a structured document that demonstrates the safety and performance of your medical device by comparing it to existing products and analyzing relevant clinical evidence.
Under the EU MDR, a CER is required for all device risk classes (I, IIa, IIb, and III). Even self-certified Class I devices must have a CER in place, though the level of detail and supporting evidence will increase with higher-risk classifications.
Another point about equivalent devices: using the concept of equivalence to sidestep having to do your own clinical trials is a really tough case to make. NBs scrutinize equivalence claims intensely; you need to show equivalence on technical, biological and clinical grounds, and you generally need sufficient access to the comparator’s data. The reason for conducting an equivalence analysis (especially on products that have already been assessed for conformity by a NB) is both to assess whether you can reasonably argue equivalence (if you’re one of the lucky ones!) and to understand the argumentation used by the manufacturers of these products in their clinical trials.
This isn’t something to do casually, though. CERs demand rigor. That means someone skilled in research methodology and literature analysis needs to take the lead. I highly recommend using someone with documented clinical research and literature-review experience (MEDDEV/MDCG expect this). A strong CER writer or consultant can deliver a systematic review and equivalent device analysis that immediately moves your submission forward. The outputs? Finished sections of your CER, clearer trial requirements, sharper claims, and a well-documented risk strategy.
Another reason to do it right: your CER is a living document. It isn’t something you complete once and then set aside. After your initial systematic review and equivalence analysis, you’ll be expected to update the CER with updates tied to new evidence and your post-market clinical followup (PMCF) plan. PMCF data feed directly back into the CER to confirm that your device continues to perform as intended, to identify any new risks, and to show regulators that you’re actively monitoring safety and performance over time. In other words, you’ll be stuck with this document for a long time. Do it right the first time!
Done right, your CER isn’t just a regulatory requirement. It’s a roadmap. It helps you shape your product claims, clarify your trial strategy, and sharpen your pitch to investors or partners.
So don’t wait until your trial data is in. Start your CER early, use it to guide your development, and let it work for you. By the time you’re ready to submit, you’ll have more than just compliance — you’ll have a cleaner, stronger, more confident story for your device. And you’ll have a living document that won’t make you cringe every time you open it.
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