Medical device regulation is important. Not just because we work with them. But because they control and regulate devices that diagnose, treat, and monitor literally all health disorders. And for this very reason, no matter what your opinions are on the regulations, you want them there.
Since the regulations serve an important purpose, they also have to be strict. So, before presenting any medical gadget to the market, it must undergo clinical testing to demonstrate its safety and efficacy. As medical device manufacturers, we have to submit documents that prove the device is worth selling. That is the Clinical Evaluation Report.
Most medical regulatory experts are aware of the documentation needed to submit a thorough clinical evaluation report. However, other unexpected paperwork may be required in order to have the device approved. In this blog post, we’ll list some documents you weren’t aware of that you might need.
One document that many professionals tend to overlook is the Complaint Data Report. This data gives you insights into the device’s real-life performance and identifies any adverse events that might have happened. Since this data is gained from patient complaints, collecting it doesn’t cost the company too much either. It also helps create your brand reputation over time.
The report should also include the number of complaints received and how the company addressed these concerns. Remember how the EU MDR really focuses on a good PMS? This report can help regulatory authorities like notified bodies understand how your product operates in real-world situations and build your PMS efforts.
When you have a device in the market, wouldn’t you like to tell authorities just how many people rely on it? Sales volume refers to the number of devices sold, the product’s market share, and the overall money generated through sales, etc. This report shows regulatory authorities the device’s demand and its commercial viability. It also helps manufacturers calculate the negative or positive impact of recent changes.
Risk management strategies
Okay, so risk management by itself is an important segment of the clinical evaluation report. The EU authorities want you to come up with a solid risk management program and implement the process. A risk management plan usually describes the potential qualitative and quantitative aspects of clinical safety and determines residual risks and side effects and how the company plans on managing risk. The plan should outline the risk assessment methodology, risk control procedures, and risk monitoring strategies. It gives essential information regarding the product’s safety and allows regulatory authorities to determine whether the product’s benefits outweigh its risks.
Clinical data appraisal document
Whatever clinical data you present to the authorities needs to be accurate beyond doubt. That is where appraisal comes in. The EU MDR requires you to “appraise all relevant clinical data by evaluating their suitability for establishing the safety and performance of the device.”
In short, after all the data are collected for clinical evaluation reports, they need to be evaluated on their relativity to the device’s intended purpose, benefits, risks, etc. As much of the data is collected through surveys, studies, and trials, the methodology of the data collection, sample size, bias, and quality of the data all need to be carefully assessed.
Evidence for equivalence
If you are claiming that your device is equivalent to another existing and approved device to use its data, you need to prove to the authorities that the devices are indeed equivalent. It usually includes a comparison of the two devices’ performance features, as well as evidence that your device fulfills the same regulatory standards as the previously approved device.
Proof of Sufficient clinical evidence
One of the documents people tend to forget about is the proof of sufficient clinical evidence. Now, this is tricky since the MDR doesn’t specify exactly how much clinical evidence is classified as “sufficient.” That is entirely up to you to determine.
This might contain information about existing products on the market, as well as data from clinical trials or case reports. You also might want to add information about your device’s intended clinical performance, its impact on patient outcomes, and any associated risks, etc.
The evidence needs to be relevant, reliable, and up-to-date. For that, the collected data should be presented in a comprehensive form after analysis. The proof of sufficient clinical evidence should be presented in a way that “proves” that the data presented is enough.
Defining the lifetime of a device and lifetime data
This is a requirement for almost all devices that mention “device lifetime” in their CER. Since a lifetime is an undetermined duration of time, you might want to mention how long the lifetime could be. In particular, you may be required to submit any potential changes or degradation over time, as well as their clinical implications. Also, in PMS plans, you have to mention how you plan to continually collect data during the device’s lifetime. You may also be required to supply information about the device’s long-term safety and effectiveness, as well as any potential risks that may surface over time.
Evidence of state-of-the-art
The state-of-the-art or SoA needs to be established first before the device can be evaluated against it. This entails providing information about the current state-of-the-art technology in your sector and demonstrating that your device is at least as excellent, if not better, than current technology. Providing this information demonstrates that you have properly researched the market and that your device meets current industry standards.
State of the art also changes over time, so each time the CER is updated, necessary changes should be made so it goes along the current SoA.
Clinical development strategy response
This is specific to the devices that are mentioned in Article 61 (2) of EU MDR. Generally, these are class IIb and III devices that are used to administer or remove a medical substance within the human body.